Lumbar manipulation and exercise for the treatment of acute low back pain in adolescents: a randomized controlled trial

Abstract

Objectives:

Low back pain (LBP) is a common condition in adolescents. Although much has been written about the efficacy of lumbar manipulation for adults with LBP, little is known about its effectiveness in adolescents. This study had two primary aims: (1) to assess the efficacy of adding lumbar manipulation to an exercise program in adolescents with acute (<90 days) LBP and (2) to report and assess any adverse reactions associated with lumbar manipulation noted in this study.

Methods:

Patients were randomly assigned to receive lumbar manipulation or sham manipulation. All patients performed 4 weeks of physical therapy exercise. Pain, patient-specific functional scale (PSFS), and global rating of change (GROC) scores were measured at evaluation, 1 week, 4 weeks, and 6 months. Relative risk was calculated for adverse reactions noted.

Results:

We recruited 35 consecutive patients with acute LBP. One patient was excluded after being diagnosed with a spondylolysis, 34 patients remained for analysis. Both groups experienced significant improvement over time in all measures. There were no differences between groups for pain, PSFS, or GROC scores. No increased risk of adverse reaction from lumbar manipulation was noted.

Discussion:

The addition of lumbar manipulation to exercise did not benefit adolescents with acute LBP. There was not an increased risk of an adverse reaction noted in this study from lumbar manipulation performed on adolescents. Further research needs to be done to identify factors that predict positive outcomes following lumbar manipulation in adolescents.     

Lumbar manipulation and exercise for the treatment of acute low back pain in adolescents: a randomized controlled trial

ObjectivesLow back pain (LBP) is a common condition in adolescents. Although much has been written about the efficacy of lumbar manipulation for adults with LBP, little is known about its effectiveness in adolescents. This study had two primary aims: (1) to assess the efficacy of adding lumbar manipulation to an exercise program in adolescents with acute (<90 days) LBP and (2) to report and assess any adverse reactions associated with lumbar manipulation noted in this study.MethodsPatients were randomly assigned to receive lumbar manipulation or sham manipulation. All patients performed 4 weeks of physical therapy exercise. Pain, patient-specific functional scale (PSFS), and global rating of change (GROC) scores were measured at evaluation, 1 week, 4 weeks, and 6 months. Relative risk was calculated for adverse reactions noted.ResultsWe recruited 35 consecutive patients with acute LBP. One patient was excluded after being diagnosed with a spondylolysis, 34 patients remained for analysis. Both groups experienced significant improvement over time in all measures. There were no differences between groups for pain, PSFS, or GROC scores. No increased risk of adverse reaction from lumbar manipulation was noted.DiscussionThe addition of lumbar manipulation to exercise did not benefit adolescents with acute LBP. There was not an increased risk of an adverse reaction noted in this study from lumbar manipulation performed on adolescents. Further research needs to be done to identify factors that predict positive outcomes following lumbar manipulation in adolescents.     

A randomized,controlled trial of osteopathic manipulative treatment for acute low back pain in active duty military personnel

Objective

Acute low back pain (ALBP) may limit mobility and impose functional limitations in active duty military personnel. Although some manual therapies have been reported effective for ALBP in military personnel, there have been no published randomized controlled trials (RCTs) of osteopathic manipulative treatment (OMT) in the military. Furthermore, current military ALBP guidelines do not specifically include OMT.

Methods

This RCT examined the efficacy of OMT in relieving ALBP and improving functioning in military personnel at Fort Lewis, Washington. Sixty-three male and female soldiers ages 18 to 35 were randomly assigned to a group receiving OMT plus usual care or a group receiving usual care only (UCO).

Results

The primary outcome measures were pain on the quadruple visual analog scale, and functioning on the Roland Morris Disability Questionnaire. Outcomes were measured immediately preceding each of four treatment sessions and at four weeks post-trial. Intention to treat analysis found significantly greater post-trial improvement in ‘Pain Now’ for OMT compared to UCO (P = 0·026). Furthermore, the OMT group reported less ‘Pain Now’ and ‘Pain Typical’ at all visits (P = 0·025 and P = 0·020 respectively). Osteopathic manipulative treatment subjects also tended to achieve a clinically meaningful improvement from baseline on ‘Pain at Best’ sooner than the UCO subjects. With similar baseline expectations, OMT subjects reported significantly greater satisfaction with treatment and overall self-reported improvement (P<0·01).

Conclusion

This study supports the effectiveness of OMT in reducing ALBP pain in active duty military personnel.     

Surface electromyography of the paravertebral muscles in patients with chronic low back pain

OBJECTIVE: To investigate the differences in the electromyographic signals of patients with chronic low back pain (CLBP) and healthy subjects. DESIGN: Cross-sectional study with a matched-pair design. SETTING: University hospital. PARTICIPANTS: Thirty-one patients with CLBP and 31 healthy, matched-pair controls. INTERVENTIONS: The mean rectified surface electromyographic amplitude and muscle strength were measured during maximal voluntary contraction (MVC). During an endurance test at 60% of MVC, the electromyographic parameters of the 2 groups were compared.Main outcome measure Electromyographic measuring of local fatigue, which can be described with changes in the median frequency or by a different parameter of the power spectrum called frequency banding. RESULTS: The strength measurement revealed a deficiency of 40% in the patients and a deficit in the electromyographic amplitude of approximately 60%, compared with the control group. By pairwise comparison, the decrease in the median frequency during the endurance test was greater in the control group. In the frequency banding of the power spectrum, local fatigue was less pronounced in the CLBP patients in pairwise comparison. CONCLUSIONS: The back muscles of CLBP patients appear to be less fatigable than those of controls. The results can be explained by morphologic changes, but influences such as pain, avoidance of pain, and deconditioning, need to be considered when the results are assessed.     

Muscle activation changes after exercise rehabilitation for chronic low back pain

Marshall PW, Murphy BA. Muscle activation changes after exercise rehabilitation for chronic low back pain.

Objective

To investigate the changes in 2 electromyographic measures, flexion relaxation (FR) response and feed-forward activation of the deep abdominals, associated with low back pain (LBP) after different rehabilitation interventions.

Design

A 2×2 factorial design with subjects' self-selecting treatment with randomization after 4 weeks to either the specific exercise group or exercise advice group for a further 12-week period.

Setting

General community practitioners and university training center.

Participants

Subjects with chronic nonspecific LBP were recruited for this study. A total of 112 people were initially screened, and 60 were recruited for the study, with 50 being available for long-term follow-up.

Intervention

Four weeks of treatment (manipulative or nonmanipulation) and 12 weeks of subsequent exercise (supervised Swiss ball training or exercise advice).

Main Outcome Measures

The Oswestry Disability Index, FR response measured at T12-L1 and L4-5, and feed-forward activation of the deep abdominal muscles.

Results

More rapid improvements in disability were identified for subjects who received the supervised exercise program. The FR response at L4-5 also increased more for those who received directly supervised exercise. Long-term follow-up showed that there was still a between-group difference in the FR response, despite no difference in self-rated disability. Long-term changes were observed for the feed-forward activation of the deep abdominals; however, no exercise or treatment effects were identified.

Conclusions

Supervised exercise rehabilitation leads to more rapid improvements in self-rated disability, which were associated with greater improvement in the low back FR response.     

The audible pop is not necessary for successful spinal high-velocity thrust manipulation in individuals with low back pain

OBJECTIVE: To determine the relationship between an audible pop and symptomatic improvement with spinal manipulation in patients with low back pain (LBP). DESIGN: A prospective cohort study. SETTING: Two outpatient physical therapy clinics located in military medical centers. PARTICIPANTS: A cohort of 71 patients with nonradicular LBP referred to physical therapy. INTERVENTIONS: Participants underwent a standardized examination and standardized spinal manipulation treatment program. All patients were treated with a sacroiliac (SI) region manipulative technique and the presence or absence of an audible pop was noted.Main Outcome Measures: Subjects were reassessed 48 hours after the manipulation for changes in range of motion (ROM), numeric pain rating scale (PRS) scores, and modified Oswestry Disability Questionnaire (ODQ) scores. RESULTS: An audible pop occurred in 50 of the 71 subjects during the manipulative procedure. Both groups-those who had an audible pop and those who did not-improved over time in flexion ROM, PRS scores, and modified ODQ scores; however, there were no differences between groups (P>.05). Nineteen of the 71 (27%) patients improved dramatically (mean drop in modified ODQ, 67.6%). In 14 of the 19 dramatic responders, an audible pop occurred. However, the odds ratio (1.2; 95% confidence interval, 0.38-4.04) suggested that the occurrence of a manipulative pop would not improve the odds of achieving a dramatic reduction in symptoms after the manipulation. CONCLUSION: There is no relationship between an audible pop during SI region manipulation and improvement in ROM, pain, or disability in individuals with nonradicular LBP. Additionally, the occurrence of a pop did not improve the odds of a dramatic improvement with manipulation treatment.     

Changes in muscle activity and stature recovery after active rehabilitation for chronic low back pain

Patients with low back pain often demonstrate elevated paraspinal muscle activity compared to asymptomatic controls. This hyperactivity has been associated with a delayed rate of stature recovery following spinal loading tasks. The aim of this study was to investigate the changes in muscle activity and stature recovery in patients with chronic low back pain following an active rehabilitation programme. The body height recovery over a 40-min unloading period was assessed via stadiometry and surface electromyograms were recorded from the paraspinal muscles during standing. The measurements were repeated after patients had attended the rehabilitation programme and again at a six-month follow-up. Analysis was based on 17 patients who completed the post-treatment analysis and 12 of these who also participated in the follow-up. By the end of the six months, patients recovered significantly more height during the unloading session than at their initial visit (ES = 1.18; P < 0.01). Greater stature recovery immediately following the programme was associated with decreased pain (r = −0.55; P = 0.01). The increased height gain after six months suggests that delayed rates of recovery are not primarily caused by disc degeneration. Muscle activity did not decrease after treatment, perhaps reflecting a period of adaptation or altered patterns of motor control.     

Activation of lumbar paraspinal and abdominal muscles during therapeutic exercises in chronic low back pain patients

Arokoski JP, Valta T, Kankaanpää M, Airaksinen O. Activation of lumbar paraspinal and abdominal muscles during therapeutic exercises in chronic low back pain patients. Arch Phys Med Rehabil 2004;85:823-32.

Objectives

To assess the activities of paraspinal and abdominal muscles during therapeutic exercises for the treatment of patients with nonspecific chronic low back pain (CLBP), and to study the effects of active physical rehabilitation on these activities.

Design

A cross-sectional study comparing muscle activities during 18 stabilization exercises, and a prospective follow-up of patients with CLBP during rehabilitation.

Setting

Rehabilitation clinic in university hospital in Finland.

Participants

Nine volunteers (5 men, 4 women) aged 27 to 58 years.

Intervention

Three months of active outpatient rehabilitation (4 to 6 times in a rehabilitation clinic, supplemented with self-motivated exercise at home) supervised by a physiotherapist.

Main outcome measures

Surface electromyography was recorded bilaterally from L5 level paraspinal, rectus abdominis, and obliquus externus abdominis muscles. The recorded signal was averaged and normalized to the maximal electromyographic amplitude obtained during the maximal voluntary contraction. The measurements were taken before and after the exercise treatment period.

Results

CLBP patients showed variable trunk muscle activity patterns during the different therapeutic exercises, similar to those that we reported earlier in healthy subjects. The maximal trunk isometric extension (pre, 147.3±75.9Nm; post, 170.1±72.3Nm) and flexion (pre, 72.0±37.9Nm; post, 93.5±42.5Nm) torques did not show a significant changes during the exercise period. However, trunk rotation-flexion torque (pre, 52.9±26.5Nm; post, 82.4±65.8Nm) increased significantly (35.8%) after the exercise period (P<.05). The corresponding maximal electromyographic amplitudes of back and abdominal muscles remained unchanged. Disability, as assessed by visual analog scale and Oswestry Disability Index, did not change.

Conclusions

The CLBP patients performed therapeutic exercises with similar abdominal and back extensor muscle activities in the same way as the healthy subjects in our earlier studies. In this study, active physical rehabilitation had no effect on the abdominal and back muscle activities or on pain and functional disability indices.     

The relationships between measures of stature recovery, muscle activity and psychological factors in patients with chronic low back pain

Individuals with low back pain (LBP) often exhibit elevated paraspinal muscle activity compared to asymptomatic controls during static postures such as standing. This hyperactivity has been associated with a delayed rate of stature recovery in individuals with mild LBP. This study aimed to explore this association further in a more clinically relevant population of NHS patients with LBP and to investigate if relationships exist with a number of psychological factors. Forty seven patients were recruited from waiting lists for physiotherapist-led rehabilitation programmes. Paraspinal muscle activity while standing was assessed via surface electromyogram (EMG) and stature recovery over a 40-min unloading period was measured on a precision stadiometer. Self-report of pain, disability, anxiety, depression, pain-related anxiety, fear of movement, self-efficacy and catastrophising were recorded.Correlations were found between muscle activity and both pain (r = 0.48) and disability (r = 0.43). Muscle activity was also correlated with self-efficacy (r = −0.45), depression (r = 0.33), anxiety (r = 0.31), pain-related anxiety (r = 0.29) and catastrophising (r = 0.29) and was a mediator between self-efficacy and pain. Pain was a mediator in the relationship between muscle activity and disability. Stature recovery was not found to be related to pain, disability, muscle activity or any of the psychological factors. The findings confirm the importance of muscle activity within LBP, in particular as a pathway by which psychological factors may impact on clinical outcome. The mediating role of muscle activity between psychological factors and pain suggests that interventions that are able to reduce muscle tension may be of particular benefit to patients demonstrating such characteristics, which may help in the targeting of treatment for LBP.     

Compliance effects in a randomised controlled trial of yoga for chronic low back pain: a methodological study

Study design

Methodological study nested within a multicentre randomised controlled trial (RCT) of yoga plus usual general practitioner (GP) care vs usual GP care for chronic low back pain.

Objective

To explore the treatment effects of non-compliance using three approaches in an RCT evaluating yoga for low back pain.

Summary of background data

A large multicentre RCT using intention-to-treat (ITT) analysis found that participants with chronic low back pain who were offered a 12-week progressive programme of yoga plus usual GP care had better back function than those offered usual GP care alone. However, ITT analysis can underestimate the effect of treatment in those who comply with treatment. As such, the data were analysed using other approaches to assess the problem of non-compliance. The main outcome measure was the self-reported Roland Morris Disability Questionnaire (RMDQ).

Methods

Complier average causal effect (CACE) analysis, per-protocol analysis and on-treatment analysis were conducted on the data of participants who were fully compliant, predefined as attendance of at least three of the first six sessions and at least three other sessions. The analysis was repeated for participants who had attended at least one yoga session (i.e. any compliance), which included participants who were fully compliant. Each approach was described, including strengths and weaknesses, and the results of the different approaches were compared with those of the ITT analysis.

Results

For the participants who were fully compliant (n = 93, 60%), a larger beneficial treatment effect was seen using CACE analysis compared with per-protocol, on-treatment and ITT analyses at 3 and 12 months. The difference in mean change in RMDQ score between randomised groups was −3.30 [95% confidence interval (CI) −4.90 to −1.70, P < 0.001] at 3 months and −2.23 (95% CI −3.93 to −0.53, P = 0.010) at 12 months for CACE analysis, −3.12 (95% CI −4.26 to −1.98, P < 0.001) at 3 months and −2.11 (95% CI −3.33 to −0.89, P = 0.001) at 12 months for per-protocol analysis, and −2.91 (95% CI −4.06 to −1.76, P < 0.001) at 3 months and −2.10 (95% CI −3.31 to −0.89, P = 0.001) at 12 months for on-treatment analysis. For the participants who demonstrated any compliance (n = 133, 85%), the results were generally consistent with the fully compliant group at 3 months, but the treatment effect was smaller. The difference in mean change in RMDQ score between randomised groups was −2.45 (95% CI −3.67 to −1.24) for CACE analysis, −2.30 (95% CI −3.43 to 1.17) for per-protocol analysis and −2.15 (95% CI −3.25 to −1.06) for on-treatment analysis, which was slightly less than that for ITT analysis. In contrast, at 12 months, per-protocol and on-treatment analyses showed a larger treatment effect compared with CACE and ITT analyses: per protocol analysis −1.86 (95% CI −3.02 to −0.71), on-treatment analysis −1.99 (95% CI −3.13 to −0.86) and CACE analysis −1.67 (95% CI −2.95 to −0.40).

Conclusion

ITT analysis estimated a slightly smaller treatment effect in participants who complied with treatment. When examining compliance, CACE analysis is more rigorous than per-protocol and on-treatment analyses. Using CACE analysis, the treatment effect was larger in participants who complied with treatment compared with participants who were allocated to treatment, and the difference between ITT and CACE analyses for the fully compliant group at 3 months was small but clinically important. Per-protocol and on-treatment analyses may produce unreliable estimates when the effect of treatment is small.

International Standard Randomised Trial Number Register

ISRCTN 81079604.     

Assessing the effect of sample size, methodological quality and statistical rigour on outcomes of randomised controlled trials on mobilisation, manipulation and massage for low back pain of at least 6 weeks duration

Objectives

To assess the effect of sample size, methodological quality and statistical rigour on outcomes of randomised controlled trials (RCTs) on manual therapy (i.e. manipulation, mobilisation and/or massage) for non-specific low back pain (LBP) of at least 6 weeks duration, and to report results from RCTs with adequate sample size, methodological quality and statistical rigour.

Data sources

MedLine, EMBASE, CINAHL, AMED, Cochrane, PEDro and the library collection of the Chartered Society of Physiotherapy.

Review methods

RCTs were identified that compared manual therapy with a control or alternative intervention in adults with non-specific LBP of at least 6 weeks duration. The sample size, methodological quality (adapted 10-point van Tulder scale) and statistical rigour were then assessed. RCTs were regarded as higher quality if they fulfilled the following three criteria: (a) >40 subjects in the manual therapy group; (b) scoring >5/10 on the Van Tulder scale; and (c) reporting statistical tests that compared the change in the intervention group with the change in the control group.

Results

Ten RCTs were included in the review but only two qualified as higher quality RCTs. Results from smaller trials and lower quality RCTs showed more variation in differences between the intervention and control groups than larger or higher quality trials. Evidence from large, high-quality RCTs with adequate statistical analyses showed that, for improvement in pain and function, a mobilisation/manipulation package is an effective intervention [compared with general practitioner (GP) care], whilst manipulation used in isolation showed no real benefits over sham manipulation or an alternative intervention. No higher quality evidence considering massage was identified.

Conclusions

Many RCTs in the area of manual therapy for LBP have shortcomings in sample size, methodological quality and/or statistical rigour, but there remains evidence from higher quality RCTs to support the use of a manual therapy package, compared with GP care, for non-specific LBP of at least 6 weeks duration.     

A physiotherapist-led exercise and education program for preventing recurrence of low back pain: a randomised controlled pilot trial

Background

Before beginning a large and complex trial it is considered good practice to run a pilot study to assess the feasibility and acceptability so that quality is maintained and resources are not wasted.

A randomised controlled study of reflexology for the management of chronic low back pain

The use of complementary and alternative medicine (CAM) for the management of chronic low back pain (CLBP) continues to rise. However, questions regarding the efficacy of many CAM therapies for CLBP remain unresolved. The present study investigated the effectiveness of reflexology for CLBP. A pragmatic randomised controlled trial was conducted. N=243 patients were randomised to one of three groups: reflexology, relaxation, or non-intervention (usual care). All completed a questionnaire booklet before and after the treatment phase, and at six months follow up. This measured their general health status, pain, functioning, coping strategies and mood. After adjusting for pre-treatment scores repeated measures ANCOVA found no significant differences between the groups pre and post treatment on the primary outcome measures of pain and functioning. There was a main effect of pain reduction, irrespective of group. Trends in the data illustrated the pain reduction was greatest in the reflexology group. Thus, the current study does not indicate that adding reflexology to usual GP care for the management of CLBP is any more effective than usual GP care alone.     

A double blind randomised controlled clinical trial on the effect of transcutaneous spinal electroanalgesia (TSE) on low back pain

A double blind randomised controlled clinical trial on the effect of transcutaneous spinal electroanalgesia (TSE) on low back pain was carried out in 58 patients attending a Pain Management Unit. Four TSE instruments, two active and two sham, were used and each patient was assigned randomly to one of these. Low back pain was rated by each patient using a visual analogue scale (VAS) immediately before and immediately after a single 20min treatment of TSE and also daily for the week prior to, and the week following, the treatment. No significant difference in mean pain score was detected between the active and sham treated groups immediately after treatment or during the subsequent week. The Hospital, Anxiety and Depression scale (HAD) and the General Health Questionnaire (GHQ) were completed by each patient and there was a positive correlation between the scores achieved on these scales and the mean pain scores in both the active and sham treated groups. A post‐trial problem was the discovery that the specification of the two active TSE machines differed from the manufacturer's specification. Thus, the output frequencies were either more (+10%) or less (?17%) while the maximum output voltages were both less (?40% and ?20%), respectively. However, additional statistical analysis revealed no significant differences between the results obtained with the two active machines.     

Effectiveness of focused meditation for patients with chronic low back pain—A randomized controlled clinical trial

ObjectivesWe aimed to evaluate the effectiveness of an 8-week meditation program (focused meditation) in patients with chronic low-back pain.DesignA randomized clinical trial was conducted on 68 patients (55 years;75% female) with chronic low-back pain who scored >40 mm on a 100 mm Visual-Analogue-Scale. Subjects were allocated to an 8-week meditation program (focused meditation) with weekly 75 min classes or to a self-care exercise program with a wait-list offer for meditation. Both groups were instructed to practice at home. Outcomes were assessed baseline and after 4 and 8 weeks. The primary outcome measure was the change in mean back pain at rest after 8 weeks. Secondary outcomes included function, pain-related bothersomeness, perceived stress, quality-of-life (QOL), and psychological outcomes.ResultsTwelve (meditation) and 4 (exercise) patients were lost to follow-up. The primary outcome, pain at rest after 8 weeks, was reduced from 59.3 ± 13.9 mm to 40.8 ± 21.8 mm with meditation vs. 52.9 ± 11.8 mm to 37.3 ± 18.2 mm with exercise (adjusted group difference: −1.4 (95%CI:11.6;8.8;p = n.s.) Perceived stress was significantly more reduced with meditation (p = 0.011). No significant treatment effects were found for other secondary outcomes as pain-related bothersomeness, function, quality-of-life and psychological scores, although the meditation group consistently showed non-significant better improvements compared to the exercise group.ConclusionsFocused meditation and self-care exercise lead to comparable, symptomatic improvements in patients with chronic low back pain. Future studies should include longer-term follow-ups and develop guided meditation programs to support compliance.     

Effect of soft and prolonged Graeco-Arabic massage in low back pain - A randomized controlled clinical trial

BackgroundLow back pain (waja-uz-zahr) due to lumbar spondylosis affects approximately 60–80% of the population at any point of life. The present study was aimed to evaluate the efficacy of soft and prolonged massage with roghan-i-suranjan on low back pain.Material and methodsClinically and radiologically diagnosed patients of low back pain were randomized into test and control groups consisting 20 patients in each group. The patients in test group received soft and prolonged massage with roghan-i-suranjan; while, in control group, short wave diathermy was given on every alternate day up to 20 min for 3 weeks. The patients were assessed before and after the treatment using the VAS and ODI (OLBP) scales.ResultsVAS score was reduced to 42.14%, (p < 0.001) in massage and 13.94%, (p < 0.008) in control group after the treatment [Percentual Change (PC) between the groups = 54.35%, p < 0.001]. OLBP score was improved to 37.16% (p < 0.001) in massage and 5.93% (p < 0.0012) in control group after the treatment [PC between the groups = 29.57%, p < 0.02].ConclusionApart from the muhallil-i-awram (anti-inflammatory), mulattif (attenuative), daf-i-alam (analgesic), and musakkin (sedative) activities of the tested-drugs, the specific strokes soft and prolonged massage further enhances the evacuative and rejuvenative process through its own action of tahleel (dissolution), talteef (attenuation), taskeen (sedation), and taskheen (diaphoresis) induced by the various manipulations used in this massage. Soft and prolonged massage with tested oil was found effective in reducing the pain and improving the quality of life in the patients of low back pain.     

Acupuncture in patients with acute low back pain: A multicentre randomised controlled clinical trial

Reviews of the efficacy of acupuncture as a treatment for acute low back pain have concluded that there is insufficient evidence for its efficacy and that more research is needed to evaluate it. A multicentre randomized controlled trial was conducted at 4 primary-care centres in Spain to evaluate the effects of acupuncture in patients with acute nonspecific low back pain in the context of primary care. A total of 275 patients with nonspecific acute low back pain (diagnosed by their general practitioner) were recruited and assigned randomly to 4 different groups: conventional treatment either alone or complemented by 5 sessions over a 2-week period of true acupuncture, sham acupuncture, or placebo acupuncture per patient. Patients were treated from February 2006 to January 2008. The primary outcome was the reduction in Roland Morris Disability Questionnaire scores of 35% or more after 2weeks' treatment. The patients in the 3 types of acupuncture groups were blinded to the treatments, but those who received conventional treatment alone were not. In the analysis adjusted for the total sample (true acupuncture relative risk 5.04, 95% confidence interval 2.24-11.32; sham acupuncture relative risk 5.02, 95% confidence interval 2.26-11.16; placebo acupuncture relative risk 2.57 95% confidence interval 1.21-5.46), as well as for the subsample of occupationally active patients, all 3 modalities of acupuncture were better than conventional treatment alone, but there was no difference among the 3 acupuncture modalities, which implies that true acupuncture is not better than sham or placebo acupuncture.