Therapeutic procedures

Why ultrasound treatment is the best modality for lumbar disk herniated ?

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Point of view of why you think your modality is the best to treat lumbar disk herniated.

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Ebadi et al. BMC Musculoskeletal Disorders 2012, 13:192
http://www.biomedcentral.com/1471-2474/13/192

RESEARCH ARTICLE Open Access

The effect of continuous ultrasound on chronic
non-specific low back pain: a single blind
placebo-controlled randomized trial
Safoora Ebadi1*, Noureddin Nakhostin Ansari1, Soofia Naghdi1, Shohre Jalaei1, Mirmostafa Sadat2, Hosein Bagheri1,
Maurits W vanTulder3, Nicholas Henschke4 and Ehsan Fallah5

  • Abstract
  • Background
  • : Non-specific chronic low back pain (NSCLBP) is one of the most common musculoskeletal disorders
    around the world including Iran. One of the most widely used modalities in the field of physiotherapy is
    therapeutic ultrasound (US). Despite its common use, there is still inconclusive evidence to support its effectiveness
    in patients with NSCLBP. The objective of this study was to evaluate the effect of continuous US compared with
    placebo US additional to exercise therapy for patients with NSCLBP.

  • Methods
  • : In this single blind placebo controlled study, 50 patients with NSCLBP were randomized into two
    treatment groups: 1) continuous US (1 MHz &1.5 W/cm2) plus exercise 2) placebo US plus exercise. Patients received
    treatments for 4 weeks, 10 treatment sessions, 3 times per week, every other day. Treatment effects were assessed
    in terms of primary outcome measures: 1) functional disability, measured by Functional Rating Index, and 2) global
    pain, measured by a visual analog scale. Secondary outcome measures were lumbar flexion and extension range of
    motion (ROM), endurance time and rate of decline in median frequency of electromyography spectrum during a
    Biering Sorensen test. All outcome variables were measured before, after treatment, and after one-month follow-up.
    An intention to treat analysis was performed. Main effects of Time and Group as well as their interaction effect on
    outcome measures were investigated using repeated measure ANOVA.

  • Results
  • : Analysis showed that both groups had improved regarding function (FRI) and global pain (VAS) (P < .001). Lumbar ROM as well as holding time during the Sorensen test and median frequency slope of all measured paravertebral muscles did not change significantly in either group (P > .05). Improvement in function and lumbar
    ROM as well as endurance time were significantly greater in the group receiving continuous US (P < .05).

  • Conclusions
  • : The study showed that adding continuous US to a semi supervised exercise program significantly
    improved function, lumbar ROM and endurance time. Further studies including a third group of only exercise and
    no US can establish the possible effects of placebo US.

    Trial registration: NTR2251

    Keywords: Low back pain, Ultrasound, Functional disability, Pain, Muscle endurance, Range of motion

    * Correspondence: s_ebadi@razi.tums.ac.ir
    1Department of physiotherapy, School of Rehabilitation, Tehran University of
    Medical Sciences, Shahnazari St, Tehran, Iran
    Full list of author information is available at the end of the article

    © 2012 Ebadi et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
    Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
    reproduction in any medium, provided the original work is properly cited.

    mailto:s_ebadi@razi.tums.ac.ir

    http://creativecommons.org/licenses/by/2.0

    Ebadi et al. BMC Musculoskeletal Disorders 2012, 13:192 Page 2 of 10
    http://www.biomedcentral.com/1471-2474/13/192

    Background
    Low back pain (LBP) is a major cause of morbidity
    in high, middle and low-income countries and affects
    80–85% of people over their lifetime [1]. LBP is a com-
    mon health and socioeconomic problem in Iran. In a
    cross-sectional study in one of the largest car-
    manufacturing companies in Iran, the 1-year prevalence
    of self reported LBP was 21% (20% for males and 27%
    for females). The prevalence rate of absence due to LBP
    was 5% per annum [2]. As part of a World Health
    Organization study, LBP was detected in 15.4% of the
    population under survey in Tehran (urban area) [3] and
    in 23.4% of the population in rural areas in Iran [4].
    Specific back pain occurs in approximately 2% of all

    patients with back complaints [5]. For the majority of
    patients with LBP a specific diagnosis cannot be defined
    on the basis of anatomical or physiological abnormal-
    ities. Non-specific LBP (NSLBP) is assumed to be in-
    flammatory or mechanical in nature [6]. Chronic NSLBP
    refers to an episode of activity-limiting LBP (with no
    pain referred into either lower limb) that lasts for 3
    months or more [7].
    Non-pharmacological methods including a variety of

    physical agents are the cornerstone of the management
    of chronic LBP. Therapeutic ultrasound (US) is among
    the commonly used physical modalities for treating soft
    tissue injuries [8]. There is a dearth of evidence for the
    clinical use of therapeutic US in patients with LBP [9].
    Therapeutic US is delivered in two modes: 1) Continu-

    ous mode in which the delivery of US is non-stop
    throughout the treatment period; 2) Pulsed mode in which
    the delivery of US is intermittently interrupted [10].
    Therapeutic effects of US are classified as thermal and

    non-thermal. Ultrasonic energy causes soft tissue mole-
    cules to vibrate from exposure to the acoustic wave. This
    increased molecular motion generates frictional heat and
    consequently increases tissue temperature. This increased
    temperature, named thermal effects, is thought to cause
    changes in nerve conduction velocity, increase in enzym-
    atic activity, changes in contractile activity of skeletal mus-
    cles, increase in collagen tissue extensibility, increase in
    local blood flow, increase in pain threshold, and reducing
    muscle spasm [11].
    Acoustic waves cause normally present minute gas

    pockets in the tissue to develop into microscopic bubbles
    or cavities. With therapeutic US, stable acoustic cavita-
    tion results, whereby the microbubbles pulsate without
    imploding. This pulsation leads to microstreaming of
    fluid around the pulsating bubbles. When occurring
    around cells, this process, referred to as non-thermal
    effects, is reported to alter cell membrane activity, vascu-
    lar wall permeability, and facilitate soft tissue healing
    [12]. Traditionally, continuous US is used for its thermal
    effects. Pulsing the US is thought to minimize its thermal

    effects [10]. In fact, it is not possible to truly isolate the
    thermal and non-thermal effects as both effects occur
    with US application [13].
    Studies on the efficacy of continuous US in chronic

    LBP are lacking [8] and there is little evidence of its ef-
    fectiveness in physiotherapy practice [14,15]. However,
    lack of evidence is not evidence of lack of effect. There-
    fore, the main objective of the current study was to
    compare the effect of continuous US to placebo US
    combined with exercise therapy on the primary out-
    comes, functional status and pain of a group of patients
    with NSCLBP, as well as on the secondary outcomes, en-
    durance of paravertebral and hip muscles, and lumbar
    range of motion.

    Methods
    Study design
    The protocol of this study was approved by the Research
    Council of Rehabilitation Faculty and the Ethical com-
    mittee of Tehran University of Medical Sciences
    (TUMS). The trial was registered with the Netherlands
    Trial Registry (NTR2251). A more detailed description
    of the study protocol has been published before [16].
    Inclusion criteria in this study were as follows: 1) hav-

    ing NSCLBP, 2) age between 18 and 60. Exclusion criteria
    were: 1) having nerve root symptoms, 2) having systemic
    disease and specific conditions such as neoplasm, frac-
    tures, spondylolysthesis, spondylolysis, spinal stenosis,
    ankylosing spondylitis, previous low back surgery, 3) tak-
    ing medication for specific psychological problems, and
    4) being pregnant. Patients were recruited from three
    university hospitals of TUMS in Tehran, Iran. Patients
    were provided with oral and written information about
    the study and were asked to sign a consent form.

    Sample size
    The primary outcome measure of this study was changes
    in functional status using Functional Rating Index (FRI).
    Assuming the effect size of .8 for FRI with alpha set
    at .05 and a power of .8, and accounting for 10% drop-
    outs, the sample size needed was calculated as being 23
    patients in each group.

    Randomization
    Randomization was performed using opaque sealed
    envelopes, which were prepared by a statistician using a
    computer generated randomization schedule. Half of the
    envelopes were allocated to each group ensuring equal
    number of subjects in each group.

    Interventions
    The intervention group received continuous US plus
    semi-supervised exercise; the control group received pla-
    cebo US plus semi-supervised exercise. Patients were

    Ebadi et al. BMC Musculoskeletal Disorders 2012, 13:192 Page 3 of 10
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    requested not to take pain medications during the inter-
    vention period and not to participate in any other exer-
    cise or treatment program. All patients in both groups
    received 10 sessions of treatment, three times a week,
    every other day.

    US therapy
    Recent reviews of therapeutic US have failed to identify
    a dose–response relationship [17-19]; though intensities
    from 0.5 W/cm2 to 3 W/cm2 have been advocated [18].
    Recently published randomized controlled trials, which
    have reported significant benefits of therapeutic US over
    placebo US, have used intensities of 1 W/cm2 to 1.5
    W/cm2 [20,21].
    Mild heating in the chronic phase of injury is known

    to reduce pain and muscle spasm and to promote heal-
    ing process. More chronic lesions are treated with con-
    tinuous US. US frequency of 1 MHz is preferable when
    treating large and deep soft tissue volumes. Intensities
    between .8 to 3 W/cm2 are suggested for chronic lesions
    [10,22,23]. Therefore, we chose continuous mode with a
    frequency of 1 MHz and an intensity of 1.5 W/cm2 due
    to the chronocity of the condition and the deep position
    of lower back musculature.
    US was applied using Enraf Nonius Sonoplus 434,

    ENRAF,Netherland (coupling gel: Sono Gel, Germany).
    Slow circular movements were applied using the trans-
    ducer head over the painful paravertebral low back re-
    gion. The duration of US was estimated for each patient
    using Grey’s formula [24]. The average local exposure
    time was planned to be one minute and the effective ra-
    diating area of the transducer head was 5 cm2. For a pa-
    tient with an area of low back pain of 40 cm2, for
    example, the required total treatment time was: 1 min ×
    (40 cm2/5 cm2) = 8 minutes.
    Patients in the intervention group received continuous

    US. Placebo US was delivered according to Hashish
    et al. [25]. The therapist moved the applicator at the
    same rate and pressure as for the continuous US group.
    The machine and the light-emitting diode which sig-
    naled that its power was connected were in view of the
    subject, but the dials which indicated the US were out of
    sight. Commonly, the patient is not aware of what she/
    he should expect at the beginning of treatment with US
    and since even with real US subjects are unaware of any
    sensation at most therapeutic intensities [22], patients
    were told in both groups that they may feel some heat
    and should this cause discomfort, to notify the therapist
    in order to safeguard patients in the continuous US
    group from overheating.

    Exercise therapy
    There is strong evidence that exercise is as effective as
    other conservative treatments in chronic LBP, and

    functional and pain outcomes significantly improves in
    groups receiving exercises relative to other interventions
    [26]. Studies indicate that stretching and strengthening
    exercises can improve pain and function. Home exer-
    cises combined with therapist supervision have been
    identified as the most effective strategy for patients with
    CLBP [27].
    It is recognized that the abdominal muscles, back

    extensors, and gluteals are weak in patients with CLBP,
    which can cause significant spinal loading. Patients with
    LBP also exhibit tightness of hamstring and hip exten-
    sors, which may impair spinal mechanics. Therefore,
    strengthening and flexibility exercises are important for
    a healthy lower back [28].
    A semi-supervised exercise program was developed.

    The program included posterior pelvic tilts, sit-ups,
    bridging, quadruped exercises, and posterior hip and
    knee muscles stretching [29,30]. Patients were instructed
    to perform 2 to 3 stretches (of all muscles) per day and
    hold the stretch for 20 seconds unless it hurts. Strength-
    ening exercises started with 5 repetitions and progressed
    according to each patient’s improvement, to 3 sets of 10
    repetitions. Patients received a pamphlet describing
    exercises with figures. To emphasize correct perform-
    ance of the exercises at home, all exercises were checked
    by the therapist on each treatment session.
    Patients were asked to perform the exercises daily; the

    stretching exercises before the strengthening exercises.
    They were advised to stay active during the day, and
    walk for at least 15 minutes before exercising, which
    could also act as a warm-up. After completion of all
    treatment sessions, patients were asked to maintain the
    daily home exercises for one further month. During
    the period from the completion of the treatment to the
    follow-up measuring session (1 month), patients visited
    the clinic once a week to control their exercises for cor-
    rect performance.

    Outcome measures
    Primary and secondary outcome measures were docu-
    mented at baseline, after the final treatment session
    (after 4 weeks), and at one-month follow-up.
    Pain and function are the two most fundamental clin-

    ical outcomes for low back pain [31], while accurate as-
    sessment of lumbar range of motion has been
    recommended as a core domain in the evaluation of
    patients with lumbar dysfunction and monitoring treat-
    ment progress [32,33]. Since the endurance of trunk
    muscles has been shown to be related to the incidence
    of low back pain, surface electromyography, specifically
    power spectral analysis of EMG signals has become an
    increasingly common method for the assessment of lum-
    bar muscle activity and localized muscle fatigue and has
    been suggested as an objective, safe, easy and non

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    invasive measure for the evaluation of patients with low
    back pain [34].
    Readers are referred to the design article of this study

    for further details on assessment methods related to out-
    come measurements [16].
    The Primary outcomes were functional disability mea-

    sured by the Persian version of the Functional Rating
    Index (FRI) [35-37] and pain intensity measured during
    last week on a 100 mm visual analogue scale (VAS) [38].
    Secondary outcome measures were paravertebral

    muscle fatigue during a Biering-Sorensen test using sur-
    face electromyography [39], and lumbar flexion and ex-
    tension range of motion using the Modified-Modified
    Schober Test (MMST) [40].
    Briefly, electromyographic data acquisition was per-

    formed using an 8-channel surface EMG recorder
    (DATA Log Biometrics Ltd) and analyzed by the built in
    software, DATA LOG PC software version 7.5 (Biomet-
    rics Ltd, UK). The software applied Fast Fourier trans-
    formation to calculate median frequency and gave the
    rate of decline in median frequency (MF slope) by trend
    lines which were calculated using Linear Regression
    Analysis based upon the least squares method to pro-
    duce a slope m and an intercept of the Y-axis. Preampli-
    fied bipolar Ag-AgCl electrodes (Type NO.SX230,
    Biometrics Ltd, UK, 10 mm in diameter) with fix center
    to center inter electrode distance of 20 mm were used.
    The signal was gathered at a sample rate of 1000 Hertz
    and a gain of 1000 Decibel.

    Data analysis
    All data were analyzed using SPSS V19, SPSS Inc.,
    Chicago, IL, USA. Kolmogorov-smirnov test revealed
    normal distribution of data. Repeated measure ANOVA
    was used to determine the main and interaction effects
    of Time and Group on the outcome measures. Bonfer-
    roni test was used for pos -hoc analysis when necessary.
    An intention-to-treat analysis of the data was per-

    formed to retain data for all patients. In the case of
    dropouts, the last recorded values for the outcome mea-
    sures were used in the analysis (Last Observation Car-
    ried Forward (LOCF)). p-values ≤ .05 were considered as
    statistically significant.

    Results
    Figure 1 shows a flow chart of participants. A total of 50
    patients were randomized, 25 to each group. One patient
    in each group dropped out after the 9th session, because
    of personal reasons. Nine more patients (3 patients in
    the experimental group and 6 patients in the placebo
    group) did not complete the follow-up measurement,
    because of travelling, complete improvement or other
    personal reasons.

    Mean age of all participants was 34.7 (SD 12.6) years
    with a mean pain history of 7.0 (SD 4.6) years. There
    was no statistically significant difference in baseline
    characteristics as well as baseline outcome measures be-
    tween groups except for endurance time (Table 1). Pos-
    sible effect of endurance time at baseline was measured
    by evaluating the effect of adding this variable to the
    model using analysis of covariance (ANCOVA). It
    resulted in no change in the statistical significance of the
    Time or Group effects.
    Mean values for baseline, after 10 session treatment

    and 1-month follow up measurements as well as
    P values for baseline differences are shown in Table 2.
    As can be seen, FRI has shown improvement (decreased)
    in both groups. Also, VAS scores have dropped in both
    groups. Details of secondary outcome measures can be
    found in Table 2.
    Table 3 details the results of the mixed model ANOVA

    [Group (US and placebo US) × Time (Pre, Post, and fol-
    low-up)] showing the effect of continuous US versus
    sham US on outcome measures.

    Primary outcome measures
    There was a significant effect of Time (p < .001) on FRI. Bonferroni post-hoc test revealed that FRI scores had improved significantly after 10 treatment sessions (p < .001) and over time after one month follow-up in both groups (p < .001). The improvement of FRI scores was maintained one month after the end of the 10th

    treatment session (p = .24). Main effect of Group on FRI
    was significant (p = .004) while the Time × Group inter-
    action was not significant (p = .31).
    There was a significant effect of Time on VAS

    (p < .001). The mixed model ANOVA on VAS did not reveal a statistically significant Group effect (p = .48). Post-hoc analysis showed that VAS scores improved sig- nificantly from baseline to after the 10th session (p < .001) and continued to improve until the one-month follow-up measurement (p = .004). The Time × Group interaction was not significant (p = .48).

    Secondary outcome measures
    Main effect of Time was not significant on both flexion
    (p = .09) and extension lumbar ROM (p = .11). However,
    a significant Group effect was identified for flexion
    (p = .02) and extension (p = .01). The interaction effect
    of Time × Group on lumbar range of motion was not
    significant (flexion: p = .23, extension: p = .21).
    The values for median frequency slope did not show a

    statistically significant Time effect (p > .05); Group effect
    (p > .05) or Group × Time interaction (p > .05).
    Although main effect of Time on holding time during

    Sorensen test was not significant (p = .09), the effect of
    Group showed statistical significance (p = .01). There

    Assessed for eligibility (n = 56)

    Excluded (n = 6)
    • Not meeting inclusion criteria (n = 4)
    • Declined to participate (n = 0)
    • Other reasons (n = 2)

    Analysed (n = 25)
    • Excluded from analysis (n = 0)

    Lost to follow-up (didn’t attend the follow up
    measurement session because of personal reasons
    other than not being satisfied with the treatment)
    (n = 3)

    Allocated to continuous US group (n = 25)
    • Received allocated intervention (n = 24)

    • Did not receive allocated intervention (n = 1)
    (Discontinued intervention after session 9th
    (travelling))

    Lost to follow-up (didn’t attend the follow up
    measurement session because of personal reasons
    other than not being satisfied with the treatment)
    (n = 6)

    Allocated to placebo US group (n = 25)
    • Received allocated intervention (n = 24)

    • Did not receive allocated intervention (n = 1)
    (Discontinued intervention after session 9th
    (travelling))
    Analysed (n = 25)
    • Excluded from analysis (n = 0)

    Allocation

    Analysis

    Follow-Up

    Randomized (n=50)

    Enrollment

    Figure 1 Flow diagram of participation and withdrawals for patients in continuous ultrasound and placebo ultrasound groups.

    Ebadi et al. BMC Musculoskeletal Disorders 2012, 13:192 Page 5 of 10
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    was no interaction effect of Time × Group on this
    parameter.

  • Discussion
  • In everyday clinical practice the application of US is
    often combined with other physiotherapeutical interven-
    tions, usually with exercise therapy [41]. The aim of this
    study was to investigate whether continuous US can add
    to the effects of exercise therapy in patients suffering
    from NSCLBP compared to placebo US.
    The results showed that both FRI and VAS have

    improved after 10 sessions of treatment and over time

    Table 1 Characteristics of patients with non specific chronic l
    and placebo ultrasound groups

    Parameter Continuous US*

    (n=25)

    Mean S

    Age(years) 31.4 12

    Onset since first episode(years) 5.8 4

    BMI** 24.4 4

    Sex 25%female _ 75%male

    * Ultrasound.
    ** Body Mass Index.
    ***p values are for baseline differences between the two groups. Significance level

    after 1 month in both groups. FRI improvement was sig-
    nificantly greater in the group receiving continuous US.
    This finding is consistent with Ansari et al. [20] who
    demonstrated a better functional outcome in a continu-
    ous US group in comparison with a placebo US group.
    In their study patients did not receive any treatment in
    addition to continuous and placebo US. Other rando-
    mized trials in which the effect of US is directly com-
    pared with placebo US in NSCLBP are lacking. US is
    usually studied in comparison with other modalities
    [42,43] or is presented in a package of physiotherapy
    [44] and is also investigated in other subgroups of

    ow back pain before treatment in continuous ultrasound

    Placebo US P value***

    (n=25)

    D Mean SD

    .3 37.4 11.9 .09

    .1 8.1 4.7 .08

    .1 25.3 3.5 .39

    50%female _ 50%male

    ≤ .05.

    Table 2 Mean and SD of primary and secondary outcome measures for continuous ultrasound and placebo ultrasound
    groups at baseline, after 10 treatment sessions, and after 1 month follow up

    Parameter Continuous US* Placebo US P value***

    Before
    treatment

    After 10
    sessions

    After 1
    month

    Before
    treatment
    After 10
    sessions
    After 1
    month

    N=24 N=24 N=21 N=24 N=24 N=18

    FRI** 40.8 (14.6) 23.4 (6.9) 22.8 (7.8) 43.9 (16.9) 31.1 (13.4) 30.5 (11.9) .49

    VAS** 46.6 (17.7) 26.6 (13.8) 27.7 (14.4) 49 (16) 30.7 (13.1) 25.5 (9.9) .62

    Flexion ROM (millimeters) 48.8 (19.4) 52.4 (18.6) 52.4 (19.60) 57.4 (18.9) 59.8 (17.9) 57.5 (18.3) .13

    Extension ROM (millimeters) 19.4 (8.2) 20.12 (8.5) 21.7 (8.5) 23.6 (9.6) 24.1 (9.3) 24.7 (9.6) .11

    Endurance time(in seconds) 111.5 (33.5) 128.9 (30.2) 128.3 (26.2) 134.2 (27.1) 140.3 (43.5) 139.3 (45.8) .01

    Median frequency slope of right muscles

    Illiocostalis lumborum -.24 (.17) -.21 (.09) -.19 (.07) -.21 (.13) -.20 (.06) -.19 (.06) .56

    Multifidus -.26 (.15) -.26 (.16) -.24 (.13) -.30 (.17) -.25 (.05) -.24 (.05) .82

    Gluteus maximus -.11 (.13) -.09 (.10) -.09 (.10) -.13 (.13) -.09 (.09) -.09 (.1) .65

    Biceps femoris -.12 (.09) -.12 (.08) -.09 (.06) -.11 (.07) -.12 (.07) -.09 (.05) .83

    Median frequency slope of left muscles

    Illiocostalis lumborum -.18 (.11) -.18 (.11) -.16 (.09) -.21 (.12) -.19 (.07) -.18 (.08) .29

    Multifidus -.24 (.14) -.25 (.15) -.25 (.15) -.29 (.21) -.24 (.10) -.25 (.11) .31

    Gluteus Maximus -.06 (.04) -.06 (.06) -.08 (.05) -.09 (.07) -.08 (.05) -.09 (.08) .11

    *US: Ultrasound.
    **FRI: Functional Rating Index, VAS: Visual Analog Scale.
    ***p values are for baseline differences between the two groups at significance level ≤ .05.

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    patients with LBP other than non-specific LBP, such as
    lumbar disk herniation [45-47].
    Durmus et al. [42] in comparing 3 groups of NSCLBP

    patients who received US + exercise, Electrical Stimula-
    tion (ES) + exercise and exercise only, showed signifi-
    cantly greater improvement in pain and function of the
    ES and US groups in comparison with the control group.
    The study found no difference in function between
    groups receiving either ES, or US but the US group had
    significantly better scores regarding pain improvement.
    Mohseni et al. [43] compared manipulation and exer-

    cise treatment with US and exercise treatment in a ran-
    domized clinical trial. One hundred and twenty patients
    with chronic LBP were given a program of exercises. In
    addition, one group received spinal manipulation ther-
    apy and the other group received therapeutic US. Pain
    intensity, functional disability, lumbar movements mea-
    sured by Modified Modified Schober Test and muscle
    endurance were measured shortly before treatment, at
    the end of the treatment program and 6 months after
    randomization using surface electromyography. Al-
    though improvements were recorded in both groups,
    patients receiving manipulation/exercise showed a
    greater improvement compared with those receiving US/
    exercise at both the end of the treatment period and at
    6-month follow-up. The authors did not report on the
    details of the exercise program, and US delivery was in-
    consistent (continuous 1MHz, 1.5-2.5W/cm2 for 5 to 10

    minutes, average 6 sessions, one or two times a week)
    which could both be possible sources of difference with
    our study.
    Since the current study lacks a third group with no

    US, it is impossible to explore the effects of exercise and
    US separately except in parts where the continuous US
    group has shown significant differences in comparison
    to the placebo group. As both groups in our study
    improved significantly regarding pain, we can conclude
    that the treatment common to both groups (exercise
    and mechanical application of US head) have attributed
    to the outcome. There is strong evidence that exercise is
    an effective treatment in chronic low-back pain [48]. Ex-
    ercise programs for CLBP may be designed to reverse
    deconditioning or the fear of movement associated with
    pain. Such exercises typically include aerobic exercises
    like walking as well as strengthening and stretching regi-
    mens [27]. The specific exercises administered to
    patients in this study may have been of benefit in im-
    proving pain. Since many items of the FRI questionnaire
    are indirectly related to the pain experienced by patients
    during that specific task, the decreased pain achieved
    with treatment could have caused the patients in both
    groups to perform better during those tasks as well.
    However, the individual role of the placebo effects of

    US in the placebo group as well as the individual effect
    of mechanical movement of US head and exercising in
    both groups cannot be specified although each one may

    Table 3 Main effects of Time and Group and their
    interaction effect on primary and secondary outcome
    measures (CI=95%,) *

    Outcome measure Effects df F P value

    FRI** Time 2 75.92 <.001*

    Group 1 3.90 .004*

    Time*Group 2 1.03 .31

    VAS** Time 2 80.11 <0.001*

    Group 1 .00 .48

    Time*Group 2 .514 .98

    Lumbar flexion Time 2 3.47 .09

    Group 1 3.16 .02*

    Time*Group 2 1.48 .23

    Lumbar extension Time 2 1.53 .11

    Group 1 4.12 .03*

    Time*Group 2 1.61 .21

    Endurance time Time 2 0.63 .43

    Group 1 3.05 .05*

    Time*Group 2 1.99 .17

    Right Illiocostalis Lumborum Time 2 .39 .53

    Group 1 .01 .93

    Time*Group 2 .52 .41

    Right Multifidus Time 2 .06 .16

    Group 1 .16 .69

    Time*Group 2 .52 .48

    Right Gluteus Maximus Time 2 3.41 .73

    Group 1 .02 .89

    Time*Group 2 .52 .47

    Right Biceps Femoris Time 2 5.38 .86

    Group 1 .02 .79

    Time*Group 2 .05 .82

    Left IliocostalisLumborum Time 2 3.65 .06

    Group 1 .87 .35

    Time*Group 2 .38 .54

    Left Multifidus Time 2 1.49 .23

    Group 1 .14 .71

    Time*Group 2 1.22 .27

    Left Gluteus Maximus Time 2 .98 .33

    Group 1 .95 .33

    Time*Group 2 .86 .36

    *The effect of the US versus placebo US on outcome measures was analyzed
    using a Group (US and placebo US) × Time (Pre, Post, and follow-up) mixed
    model ANOVA at significance level ≤ .05.
    **FRI: Functional Rating Index, VAS: Visual Analog Scale.

    Ebadi et al. BMC Musculoskeletal Disorders 2012, 13:192 Page 7 of 10
    http://www.biomedcentral.com/1471-2474/13/192

    have played a part in the outcome. A placebo effect of
    US can be the result of moving the applicator head thus
    benefitting from the effects of massaging [20,25]. Con-
    tinuous movement of the applicator may increase the

    temperature of the area under treatment and may stimu-
    late the skin receptors causing the pain gate control
    mechanism to become active [20]. It has been shown
    that moving the applicator of US on the affected area
    can change the level of serum cortisol, which in turn can
    affect inflammation and swelling [25]. Patients in both
    groups could have benefitted from the Placebo effects of
    the treatment [49].
    A significant difference in the improvement of FRI

    scores in favor of the continuous US group can be
    related to the thermal and mechanical effects of continu-
    ous US.
    Morrisette et al. [50] showed that continuous 1 MHz

    US given at either 1.5 W/cm2 or 2.0 W/cm2 intensity has
    the capability of heating lumbar periarticular tissue while
    the intervening muscle may heat as well. Morrisette sta-
    ted that the temperature elevation was at a level thought
    to be sufficient to produce the theoretical therapeutic
    effects proposed with an elevation in temperature.
    Regarding secondary outcome measures, although

    lumbar flexion and extension ROM increased in both
    groups after treatment, the increase did not reach statis-
    tical significance within groups. Nevertheless, the
    amount of improvement in ROM was significantly
    greater in the continuous US group. Durmus et al. [42]
    reported significant improvement in Modified Schober
    scores in the group receiving US + exercise. However,
    this improvement was not significantly different from
    the two other treatment groups receiving ES + exercise
    and exercise only. In the study carried out by Mohseni
    et al. [43], lumbar flexion and extension ROM as mea-
    sured by MMST (Modified Modified Schober Test)
    improved significantly in US + exercise group but this
    improvement was significantly lower in comparison with
    the manipulation + exercise group. Though none of the
    studies above, had reported the exact exercises pre-
    scribed, their difference with our study can be possibly
    explained by the differences in exercise type and inten-
    sity and patient population as well as the difference in
    the dosage of US.
    Clinical assessment of movement impairment in low

    back pain is predominantly done by measuring changes
    in lumbar ROM in order to investigate patient’s response
    to treatment [51]. The reduction in pain alongside
    stretching and strengthening exercises prescribed could
    have contributed to the increase of ROM in both groups.
    The significant additional increase of ROM in the con-
    tinuous US group may be due to the thermal and mech-
    anical effects of continuous US. It has been shown that
    temporary increases in range of movement can be pro-
    duced by US treatment [52]. There is considerable evi-
    dence that the extensibility of collagen based tissues will
    change with ultrasound thermal applications as long as
    sufficient temperature change is achieved [53]. Since the

    Ebadi et al. BMC Musculoskeletal Disorders 2012, 13:192 Page 8 of 10
    http://www.biomedcentral.com/1471-2474/13/192

    therapeutic window for stretching following US applica-
    tion is limited to some 3 minutes immediately after
    treatment [54], our participants that performed exercises
    after the treatment sessions, at home, barely could have
    benefited from such thermal effect. Given that patients
    suffering from chronic low back pain usually have spasm
    [7], using continuous US could have been effective in
    decreasing spasm [10] and consequently resulting in
    greater ROM increase in comparison with placebo US.
    Considering surface EMG parameters, no significant

    effect of Time or Group was found on median frequency
    slope of all measured muscles.
    The assessment of fatigue based on SEMG techniques

    during a fatiguing contraction can be demonstrated by a
    trend of the power spectrum to lower frequencies usu-
    ally measured by the decrease in median frequency. It
    has been proposed that better endurance would exhibit
    a less precipitous decay rate of the median frequency
    [55], though conflicting opinions exist [56]. It has been
    indicated that trunk muscle endurance can be increased
    by using specific exercises [57].
    Sung [58] investigated changes in multifidi muscle en-

    durance and functional status after a 4-week supervised
    spinal stabilization exercise program in 16 patients pre-
    senting with chronic low back dysfunction (LBD).
    Results showed that Oswestry scores improved signifi-
    cantly from pre to post treatment. Significant pre- to
    post treatment increase in multifidi muscle fatigue for
    men coupled with a nonsignificant improvement in mul-
    tifidi muscle endurance for women was also seen. Sung
    [58] concluded that a 4-week spinal stabilization exercise
    program significantly improved functional status in
    patients presenting with LBD but the program was in-
    sufficient to effect muscle fatigue. In another study,
    Mohseni et al. [43] did not find any significant change in
    median frequency slope or endurance time in the group
    of patients with low back pain who received continuous
    US plus exercise for an average of 6 sessions. We also
    witnessed a nonsignificant change in MF slope of mea-
    sured paravertebral muscles, which may imply that the
    usefulness and sensitivity of this parameter was limited
    in our study.
    Regarding endurance time, the group receiving con-

    tinuous US showed a significantly greater increase than
    the placebo group. Traditionally, endurance is thought
    of as the time for sustaining a nonstationary activity,
    which ceases with fatigue [59]. One of the main reasons
    for muscle fatigue is the accumulation of metabolite
    wastes in the region and the inability of the system to
    provide adequate blood circulation to supply oxygen to
    the tissue and deplete it from wastes [60]. Additionally,
    ischemia due to inflammation and spasm is a common
    finding in chronic low back pain [7,28,61]. It is possible
    that continuous US has improved low back muscle

    fatigue by increasing blood circulation in the region and
    helping improve blood supply [17,23,61] which in turn
    have caused more sufficient and longer muscle contrac-
    tion during the test.

    Limitations
    The main limitation of this study could be that the treat-
    ing physiotherapist who collected the data was not
    blinded to the group allocation. The number of dropouts
    in our study was higher than what we had predicted at 1
    month (22%). The self-reported compliance rate seemed
    high, but it was not checked. The study lacks a third
    group without US which makes it impossible to com-
    ment on individual interventions separately.

    Conclusions
    This single blind, placebo -controlled, randomized clin-
    ical trial showed that adding 1 MHz, 1.5 W/cm2 US to a
    semi-supervised regimen of exercise had significantly
    beneficial effects on function, lumbar flexion and exten-
    sion ROM, and endurance time in patients with
    NSCLBP.
    Further studies including a third group of no US are

    needed to explore the differential effects of each inter-
    vention on patients with NSCLBP. In addition, it would
    be helpful to measure other surface electromyography
    parameters other than median frequency slope, such as
    mean frequency, initial median frequency and normal-
    ized median frequency slope to explore the possible
    effects of the method used in this study on these
    parameters.
    Studies, in which the methodological shortcomings of

    this study and similar studies are addressed, are needed
    to verify a dose response relation in patients with
    chronic low back pain.

  • Competing interests
  • The authors declare that they have no competing interests.

    Authors’ contributions
    SE and NNA came up with the original concept for the study. SN, NH, and
    MvT helped to design the study and contributed to the development of the
    manuscript. EF and MS coordinated and referred the patients, HB
    participated in the executive steps of the study and SHJ performed the
    statistical analysis. SE wrote the first draft of the manuscript with help from
    the other authors. All authors read and approved the final manuscript.

  • Acknowledgements
  • The authors would like to thank all patients included in this study. We would
    also like to thank the Research Deputy, Tehran University of Medical Sciences
    for their financial support.

  • Author details
  • 1Department of physiotherapy, School of Rehabilitation, Tehran University of
    Medical Sciences, Shahnazari St, Tehran, Iran. 2Sina Hospital, Medical Faculty,
    Tehran University of Medical Sciences, Hasanabad St, Tehran, Iran.
    3Department of Health Sciences, VU University, De Boelelaan, Amsterdam,
    The Netherlands. 4Musculoskeletal Division NHMRC Postdoctoral Fellow, The
    George Institute for Global Health, Kent St, Sydney, Australia. 5Emam Reza

    Ebadi et al. BMC Musculoskeletal Disorders 2012, 13:192 Page 9 of 10
    http://www.biomedcentral.com/1471-2474/13/192

    hospital, Medical Faculty, Army University of Medical sciences of the I.R.Iran,
    Etemadzade St., Tehran, Iran.

    Received: 15 December 2011 Accepted: 26 September 2012
    Published: 2 October 2012

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    Cite this article as: Ebadi et al.: The effect of continuous ultrasound on
    chronic non-specific low back pain: a single blind placebo-controlled
    randomized trial. BMC Musculoskeletal Disorders 2012 13:192.

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      Abstract
      Background
      Methods
      Results
      Conclusions
      Trial registration
      Background
      Methods
      Study design
      Sample size
      Randomization
      Interventions
      US therapy
      Exercise therapy
      Outcome measures
      Data analysis
      Results
      Primary outcome measures
      Secondary outcome measures
      Discussion
      Limitations
      Conclusions
      Competing interests

    • Authors´ contributions
    • Acknowledgements
      Author details
      References

    Clinical Study
    Comparison of High-Intensity Laser Therapy and Ultrasound
    Treatment in the Patients with Lumbar Discopathy

    Ismail Boyraz,1 Ahmet Yildiz,1 Bunyamin Koc,1 and Hakan Sarman2

    1Department of Physical Medicine and Rehabilitation Training and Research Hospital,
    Abant Izzet Baysal University Medical School, Bolu, Turkey
    2Department of Orthopeadic and Traumatology, Abant Izzet Baysal University Medical School, Bolu, Turkey

    Correspondence should be addressed to Ismail Boyraz; boyraz@yahoo.com

    Received 2 January 2015; Accepted 24 February 2015

    Academic Editor: Vida Demarin

    Copyright © 2015 Ismail Boyraz et al. This is an open access article distributed under the Creative Commons Attribution License,
    which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

    The aim of the present study was to evaluate the efficiency of high intensity laser and ultrasound therapy in patients who were
    diagnosed with lumbar disc herniation and who were capable of performing physical exercises. 65 patients diagnosed with lumbar
    disc were included in the study. The patients were randomly divided into three groups: Group 1 received 10 sessions of high intensity
    laser to the lumbar region, Group 2 received 10 sessions of ultrasound, and Group 3 received medical therapy for 10 days and
    isometric lumbar exercises. The efficacy of the treatment modalities was compared with the assessment of the patients before the
    therapy at the end of the therapy, and in third month after the therapy. Comparing the changes between groups, statically significant
    difference was observed in MH (mental health) parameter before treatment between Groups 1 and 2 and in MH parameter and VAS
    score in third month of the therapy between Groups 2 and 3. However, the evaluation of the patients after ten days of treatment did
    not show significant differences between the groups compared to baseline values. We found that HILT, ultrasound, and exercise
    were efficient therapies for lumbar discopathy but HILT and ultrasound had longer effect on some parameters.

    1. Introduction

    The lumbar region is the most common site involved in
    musculoskeletal pain. In developed countries, low-back pain
    ranks second after headaches among the other causes of pain.
    Of people living in industrialized countries, approximately
    80% suffer from low-back pain at a certain time in their lives
    [1]. Approximately 10% of people who experience low-back
    pain develop chronic low-back pain. Approximately 1% of the
    population is completely disabled due to low-back pain. Low-
    back pain often starts at a young age, and the prevalence is
    the highest in middle-aged population [1]. Intervertebral disc
    diseases, which are an important etiological cause of low-back
    pain, often occur in the lumbar region (61.94%). The majority
    of people presenting with low-back pain have problems with
    intervertebral discs. There are many different approaches
    in the management of low-back pain. There is a wide
    spectrum of treatment options including patient education,
    behavioral therapies, lumbar support, and physical therapy
    modalities such as massage, traction, superficial heaters, deep

    heaters, transcutaneous electrical nerve stimulation (TENS),
    and laser. The treatment of disc herniation is important to
    control pain, to prevent the recurrence, and development of
    chronic pain and disability, and to accelerate the return to
    work process. Exercises and education on lumbar protective
    measures have become prominent in recent years [2].

    The term laser originated as an acronym for “light
    amplification by stimulated emission of radiation.” The basic
    principle of laser devices is the amplification of electron spin
    rates by passing photon energy through a particular medium
    to produce a single directional laser beam having a different
    wavelength than the original light beam [3]. The action
    mechanism of lasers is based on tissue stimulation. This
    stimulation occurs at the level of the cell, vascular structure,
    interstitial tissue, and immune system. Furthermore, laser has
    direct effects when applied to the tissues locally and systemic
    effects when applied to acupuncture points [4]. The analgesic
    and anti-inflammatory effects of laser can be explained by
    many mechanisms. Laser produces reactive vasodilation by
    decreasing the pain sensation in the sensory nerve endings

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    and the spasm in the muscle arterioles. It exerts analgesic
    and anti-inflammatory effects by promoting regeneration
    and increasing the release of beta-endorphins through the
    induction of protein synthesis in the rheumatoid synovial
    fluid. Laser is also suggested to stimulate hematopoiesis in the
    bone marrow and exert antibacterial effects by stimulating
    the immune system [4]. Lasers do not cause a significant
    change in the tissue temperature. This finding indicates that
    the potential physiological effects of laser are independent
    from heat. Recent studies implicated laser in the regenerative
    process of the tissue, bone formation, synthesis of new carti-
    lage tissue, and synthesis of the cartilage matrix [5, 6]. It was
    found that Nd: YAG lasers contribute to the healing process
    in the tendons and ligaments and prevent the formation of
    fibrosis [7]. Some studies showed that low level laser therapy
    combined with exercise had more beneficial than exercise
    alone in chronic low-back pain for the long term [8–10].

    Superficial and deep heaters used in the treatment of
    lumbar disc herniations have an important place in physical
    therapy applications. Superficial and deep heaters have mul-
    tiple effects such as vasodilation, increased pain threshold,
    and increased collagen production in connective tissues. It
    was found that ultrasound (US) exerts many effects mediated
    by its thermal effects such as increase in nerve transmission
    speed and enzymatic activity, increase in the contractility of
    skeletal muscles, increase in the elongation of collagen tissue,
    increase in blood flow rate, decline in pain threshold, and
    relief of muscle spasms [11]. US is important physical therapy
    agent used in the treatment of musculoskeletal disorders [12].

    The aim of the present study is to evaluate the efficiency
    of high intensity laser and ultrasound therapy in patients
    who are diagnosed with lumbar disc herniation and who are
    capable of performing physical exercises.

    2. Materials and Methods

    The present study included patients who were admitted
    to the outpatient or inpatient clinic of Physical Therapy
    and Rehabilitation at our hospital to undergo a physical
    therapy program and who met the study inclusion criteria.
    The diagnoses of the patients were established by medical
    history, physical examination, and results of imaging studies.
    The diagnose of 65 patients confirmed with lumbar MRI as
    lumbar disc herniation. The patients were randomly divided
    into three groups: Group 1 received 10 sessions of high
    intensity laser to the lumbar region five sessions per week,
    Group 2 received 10 sessions of US to the lumbar region five
    sessions per week, and Group 3 received medical therapy
    (NSAII) for 10 days and all of the patients in three groups
    performed isometric lumbar exercises. The efficacy of the
    treatment modalities was compared with the assessment of
    the patients before the therapy, at the end of the therapy, and
    in third month after the therapy.

    The patients, who were diagnosed with lumbar disc her-
    niation on lumbar MRI performed, who were not working on
    occupations requiring intensive effort and in whom physical
    therapy was not contraindicated, who did not have congenital
    abnormalities or history of trauma, and who had sufficient
    mental capacity to understand and answer the questions

    asked in the assessment scales, were included in the study. The
    patients who had a history of injection to the lumbar region
    in the last four weeks or who had severe osteoporosis, history
    of lumbar surgery, acute trauma, inflammatory pain, neuro-
    logical disorder, or lumbar instability, patients who received
    physical therapy in the last three months, and patients with
    uncontrolled or severe cardiovascular or metabolic disorder
    were excluded from the study.

    A detailed medical history was obtained from the patients
    and all underwent physical examination of the locomotor
    system. The patients were randomly divided into three
    groups: Group 1 included 20 patients, Group 2 included
    25 patients, and Group 3 included 20 patients. VAS (visual
    analog scale) was used to assess the pain level of the patients.
    The Oswestry disability index, SF-36 (short form 36), was
    used to evaluate the functional and psychologic status of the
    patients. A locomotor system examination was repeated after
    the therapy.

    The patients in Group 1 received laser therapy 3.8 watts
    for 14 minutes at a wavelength of 1064 nm. The total energy
    received was 1800 joules. A cosmogamma Cyborg laser
    device was used as the high intensity laser in this study.
    This device produces laser beams with a wavelength of
    1064 nm. This device is also known as a gallium aluminum
    arsenide laser (GaAlAs laser) and designed to provide a fiber
    output of at least 10 w (±10%). The device has continuous,
    pulsed, and high pulsed modes. Different treatment programs
    are recorded on the device memory according to different
    diagnoses. The treatments were applied to the lumbar region
    using beam expanders for the treatment of large areas up to
    120 cm2.

    The patients in Group 2 received a US therapy. A Chat-
    tanooga intelect mobile US device was used in the treatments.
    The intelect mobile US device allows the application of 1
    or 3 MHz, and 20% or 50% or continuous modes without
    any need to change the applicators. In the present study,
    US was applied at 1.5 watt/cm for six minutes to the lumbar
    paravertebral area. In addition, an isometric lumbar exercise
    program was initiated to be performed with five repetitions in
    each set (modified straightening and pelvic tilt exercises) in
    Groups 1 and 2. The repetitions of both sets were increased up
    to ten, provided that this did not increase the patient’s pain.

    The patients in Group 3 received a medical therapy agent
    for ten days in addition to two sets of lumbar isometric
    exercises (pelvic tilt and modified straightening), which were
    repeated five times in the morning and at night. All patients in
    the study were trained on lumbar exercises. The patients were
    administered pelvic tilt and modified straightening exercises,
    to be performed in two sets, each containing at least five
    repetitions during periods with intensive pain. The patients
    were instructed to increase the number of repetitions to ten
    in each set when the treatment provided some relief. The
    patients were informed that the key to prevent recurrences
    and provide functional recovery was making the exercises
    part of their lives.

    The demographic features of the patients were ques-
    tioned. The patient’s age, place of residence, comorbid con-
    ditions, and medications were questioned. The patients were

    BioMed Research International 3

    assessed before and after the therapy. The lumbar MR images
    of the patients were evaluated.

    Statistical Analysis. All statistical analyses were performed
    using SPSS 17.0 for Windows (SPSS, Chicago, IL, USA). The
    Kolmogorov-Smirnov test was used to test the normality of
    the data distribution, and the data were expressed as the
    mean and standard deviation. The chi-square test was used
    to compare the categorical variables between the groups.
    The one-way ANOVA test was used for comparisons of the
    parametric continuous data. The Kruskal-Wallis test was used
    for the nonparametric continuous data. Pearson’s correlation
    analysis was used to examine the associations between the
    variables, and a linear regression analysis was performed
    to identify independent predictors of the pain domains of
    the SF-36. A two-sided ? value < 0.05 was considered to be statistically significant. A repeated measures ANOVA was used to analyze the changes in variables. Significant differences were determined by Bonferroni post hoc tests.

    3. Results

    Of 20 patients in Group 1, 5 were males and 15 were females.
    Of 25 patients in Group 2, 8 were males and 17 were females.
    Of 20 patients in Group 3, 9 were males and 11 were females.
    There was no statistically significant difference in terms of
    gender distribution. The mean age was 58.4 ± 10.76 years in
    Group 1, 61±10.47 years in Group 2, and 54.6±14.89 years
    in Group 3. There was no significant difference between the
    groups in terms of age (?> 0.05).

    The lumbar MRI reports of 65 patients with lumbar disc
    herniations were examined. Of these patients, 53 had disc
    protrusion at one or more levels and 12 had disc extrusion.
    Of 65 patients, 32 had compression of the nerve roots at one
    or more levels. There was no significant difference in terms of
    compression of the nerve root and level of disc herniation.

    The comparison of parameters in Group 1 before the
    treatment and at the end of the therapy revealed significant
    changes in VAS (visual analog scale), Oswestry scale score,
    BP (body pain), GH (general health), VT (vitality), and SF
    (social functioning) (? < 0.05). There was no significant change in PF (Physical Function), RP (Restricted Physical Roles), RE (Restricted Emotional roles), and MH (Mental Health) parameters (? > 0.05). Changes of Oswestry scale
    score and PF, BP, GH, and VT parameters in third month after
    the therapy compared to values at the end of the treatment
    were statically significant (Table 1).

    The comparison of parameters in Group 2 before the
    therapy and at the end of the therapy revealed significant
    changes in VAS score, Oswestry scale score, and PF, RF, BP,
    GH, VT, SF, RE, and MH parameters (?< 0.05). Comparing results in third month of the treatment and at the end of the treatment, statically significant changes were determined in Oswestry scale score and PF, BP, GH, and MH parameters (Table 1).

    The comparison of parameters in Group 3 before the
    therapy and at the end of the therapy revealed significant
    changes is VAS, Oswestry scale score, and PF, RP, BP, GH, and
    RE parameters (? < 0.05). VT, SF, and MH parameters did

    not significantly change in Group 3 (? > 0.05). Comparing
    results at the end of the treatment and in third month of
    the treatment, statically significant change was continuing in
    Oswestry scale score and BP and GH parameters (Table 1).

    Comparing the changes between groups, statically sig-
    nificant difference was observed in MH parameter before
    treatment between Groups 1 and 2 and in MH parameter and
    VAS score in third month of the therapy between Groups 2
    and 3. However, the evaluation of the patients after ten days
    of treatment did not show significant differences between the
    groups compared to baseline values (Table 1).

    4. Discussion

    In the present study, a total of 65 patients with lumbar disc
    herniation in the high intensity laser treatment (HILT), US,
    and control groups were compared in terms of their scores
    in VAS, SF-36, and Oswestry scale. In all treatment groups,
    most parameters measured showed significant changes. The
    differences in the three treatment groups did not achieve
    statistical significance in terms of some parameters (? >
    0.05). The comparison of parameters in Group 1 before
    and at the end of the therapy revealed significant changes
    in VAS score, Oswestry scale score, BP, GH, VT, and SF.
    The comparison of parameters in Group 2 before and at
    the end of the therapy revealed significant changes in VAS,
    Oswestry scale score, and PF, RF, BP, GH, VT, SF, RE, and
    MH parameters. The comparison of parameters in Group
    3 before therapy and at the end of the therapy revealed
    significant changes in terms of VAS, Oswestry scale score,
    and PF, RP, BP, GH, and RE parameters. Improvement of
    Oswestry scale score and PF, BP, GH, and VT parameters in
    Group 1, improvement of Oswestry scale score and PF, BP,
    GH, and MH parameters in Group 2, and improvement of
    Oswestry scale score and BP and GH parameters in Group
    3 were going on increasingly for three months. VAS scores
    were better than compared to value before the therapy and at
    the end of the therapy but there was no significant difference
    between VAS scores in third month after the therapy and at
    the end of the therapy.

    Fiore et al. demonstrated the short term effects of a high
    intensity laser on lumbar pain in a study that included 30
    patients, 15 of which received US therapy and 15 who received
    laser therapy. They reported more prominent pain relief and
    recovery disability in the HILT group compared to US group
    after three weeks of treatment. The rate of decline in the
    VAS score in the two patient groups was 10% in favor of
    the HILT group and 20% in Oswestry scale in favor of the
    HILT group. They did not have control group as an important
    lack of the study [13]. Alayat et al. conducted a randomized,
    single-blind, placebo-controlled study to evaluate the long
    term effects of HILT in patients with lumbar pain. The study
    included 72 patients, and 28 patients in Group 1 received
    HILT + exercise therapy, 24 patients in Group 2 received
    placebo laser + exercise, and 20 patients in Group 3 received
    HILT. They performed a total of 12 sessions of therapy for
    four weeks. The patients were evaluated at baseline, fourth
    week, and twelfth week. This study showed higher efficacy of

    4 BioMed Research International

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    BioMed Research International 5

    the HILT + exercise program compared to placebo HILT +
    exercise program and only exercise group [14]. Conte et al.
    evaluated the HILT + lumbar school versus lumbar school
    alone and studied 28 patients using VAS and Oswestry scale.
    They emphasized that the HILT + lumbar school provided
    higher improvement in Oswestry and VAS scores compared
    to the lumbar school alone. Furthermore, they concluded that
    the laser possessed low biological activity and produced little
    side effects, if any, compared to pharmacological therapies
    [15]. A meta-analysis of studies on low intensity laser therapy
    reported positive effects on tissue repair and pain control
    at various levels. However, these studies did not specifically
    evaluate lumbar pain [16]. Monochromatic laser beams can
    inherently modulate cellular and tissue functions. There
    are controversial data regarding the effects of low intensity
    laser on lumbar pain. Despite this controversy, low intensity
    laser therapy has demonstrated efficacy in the short term
    compared to the placebo when the patients were assessed
    using VAS and Oswestry scales [17]. Considering last surveys,
    HILT therapy can be good alternative physical therapy agent
    for the patients with lumbar disc herniation. It does not
    have distinct adverse effect and we did not encounter any
    complication in our study.

    Therapeutic US is an important treatment agent in mus-
    culoskeletal disorders [12]. Ebadi et al. evaluated a total of 50
    patients divided into two groups in order to investigate the
    efficacy of continuous US in chronic lumbar pain. The first
    group received continuous US and exercise, and the second
    group received placebo US + exercise. They performed a total
    of ten sessions of therapy for four weeks. They evaluated the
    patients before and after the therapy using FRI (functional
    rating index), VAS score, ROM, and endurance time. They
    found significant improvement in the FRI index in the
    continuous US group. The decrease in VAS scores, increase
    in lumbar ROM, and endurance time were more prominent
    in the continuous US group compared to the placebo US
    group. The limitation of this study was that the effectiveness
    of placebo US was not evaluated with the addition of a third
    group that received exercise only [18]. Durmus et al. also
    evaluated three patients groups that received either US +
    exercise therapy, electrical stimulation, and exercise therapy
    or exercise therapy alone for lumbar pain. They found that
    US + exercise provided better pain relief compared to the
    other two treatment modalities [19]. Doğan et al. divided 60
    patients into three groups in order to evaluate three different
    approaches in the treatment of chronic lumbar pain. In their
    study, Group 1 received home exercises + aerobic exercise,
    Group 2 received physical therapy (hot-pack, TENS, and US)
    and home exercises, and Group 3 received home exercises
    alone. They found a significant reduction in the pain level and
    an increase in aerobic capacity, but there was no significant
    difference between the groups. They stated that the rate
    of functional disability and physiological disturbances were
    lower in the physical therapy and home exercise group [20].
    In the study by Grubisić et al. that evaluated the therapeutic
    efficiency of US in the treatment of chronic lumbar pain,
    16 out of 31 patients received US therapy. Ongoing medical
    therapies of the study participants were not changed and
    the patients were only allowed to take paracetamol during

    painful periods. In the control group, a US device was
    switched off while performing physical therapy. At the end
    of the treatment period, US was found to be more effective
    in providing pain relief; however, US was not found to
    be superior to the control group in providing functional
    improvement [21]. Basford et al. reported that US therapy has
    gained a wide acceptance in routine practice in the treatment
    of chronic lumbar pain; however, the evidence is not strong
    enough to support the efficiency of this therapy [17]. US is
    used for a long time in physical therapy and it is so safe and
    effective treatment agent in several locomotor diseases. In our
    study, we obtained improvement in terms of some parameters
    in US group. We did not encounter any complication.

    Limitation of this study may be the number of the
    patients. If we received a larger numbers of patients, the effect
    of HILT would be displayed obviously. We permitted the
    patients to take medicine only during treatment period. It
    may be seen disadvantage for the short term effect of the
    treatment. Further studies with a larger number of patients
    and controls are required to evaluate the long term effects of
    the therapies.

    There were no studies in the literature that compared the
    effectiveness of HILT, US, and medical therapies in patients
    with lumbar disc problems, which have an important place
    in the etiology of acute and chronic lumbar pain. The current
    literature search did not show a sufficient number of similar
    studies. There are a very limited number of studies that
    evaluated the efficiency of HILT in lumbar pain. The number
    of patients included in the present study was similar to that
    reported in other studies in the literature. The inclusion of a
    control group allowed for the comparison of HILT and US
    therapies with exercise therapies in the short term. However,
    the evaluation of the patients aftermath ten-day treatment
    did not show significant differences between the groups
    compared to baseline values. This may have been caused
    by the fact that the patients in our study were allowed to
    take medical therapies during the most painful periods. The
    patients in the HILT and US groups were not allowed to take
    medical therapies unless they had extreme pain. We found
    that HILT, US, and exercise were efficient therapies for lumbar
    discopathy but HILT and US had longer effect in terms of
    some parameters. Exercise therapy should never be ignored
    to treat and prevent lumbar back pain.

    Disclosure

    All authors have no financial disclosures. They do not accept
    any grants.

    Conflict of Interests

    The authors declare that there is no conflict of interests
    regarding the publication of this paper.

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