Photobiomodulation therapy is not better than placebo in patients with chronic nonspecific low back pain: a randomised placebo-controlled trial.

ABSTRACT: Photobiomodulation therapy (PBMT) has been used in several musculoskeletal disorders to reduce pain, inflammation, and promoting tissue regeneration. The current evidence about the effects of PBMT on low back pain (LBP) is still conflicting. We aimed to evaluate the effects of PBMT against placebo on pain intensity and disability in patients with chronic nonspecific LBP. This was a prospectively registered, randomised placebo-controlled trial, with blinded patients, therapists, and assessors. The study was conducted on an outpatient physical therapy clinic in Brazil, between April 2017 and May 2019. A total of 148 patients with chronic nonspecific LBP were randomised to either active PBMT (n = 74) or placebo (n = 74). Patients from both groups received 12 treatment sessions, 3 times a week, for 4 weeks. Patients from both groups also received an educational booklet based on "The Back Book." Clinical outcomes were measured at baseline and at follow-up appointments at 4 weeks, 3, 6, and 12 months after randomisation. The primary outcomes were pain intensity and disability measured at 4 weeks. We estimated the treatment effects using linear mixed models following the principles of intention-to-treat. There was no clinical important between-group differences in terms of pain intensity (mean difference = 0.01 point; 95% confidence interval = -0.94 to 0.96) and disability (mean difference = -0.63 points; 95% confidence interval = -2.23 to 0.97) at 4 weeks. Patients did not report any adverse events. Photobiomodulation therapy was not better than placebo to reduce pain and disability in patients with chronic nonspecific LBP.

Photobiomodulation therapy does not decrease pain and disability in people with non-specific low back pain: a systematic review.

QUESTION: In people with non-specific low back pain (LBP), what are the effects of photobiomodulation therapy (PBMT) on pain, disability and other outcomes when compared with no intervention, sham PBMT and other treatments, and when used as an adjunct to other treatments? DESIGN: Systematic review of randomised trials with meta-analysis. PARTICIPANTS: People with acute/subacute or chronic non-specific LBP. INTERVENTIONS: Any type of PBMT (laser class I, II and III and light-emitting diodes) compared with no treatment, sham PBMT and other types of treatment, or used as an adjunct to another treatment. OUTCOME MEASURES: Pain intensity, disability, overall improvement, quality of life, work absence and adverse effects. RESULTS: Twelve randomised controlled trials were included (pooled n = 1,046). Most trials had low risk of bias. Compared with sham PBMT, the effect of PBMT on pain and disability was clinically unimportant in people with acute/subacute or chronic LBP. In people with chronic LBP, there was no clinically important difference between the effect of PBMT and the effect of exercise on pain or disability. Although benefits were observed on some other outcomes, these estimates were imprecise and/or based on low-quality evidence. PBMT was estimated to reduce pain (MD -11.20, 95% CI -20.92 to -1.48) and disability (MD -11.90, 95% CI -17.37 to -6.43) more than ultrasound, but these confidence intervals showed important uncertainty about whether the differences in effect were worthwhile or trivial. Conversely, PBMT was estimated to reduce pain (MD 19.00, 95% CI 9.49 to 28.51) and disability (MD 17.40, 95% CI 8.60 to 26.20) less than Tecar (Energy Transfer Capacitive and Resistive) therapy, with marginal uncertainty that these differences in effect were worthwhile. CONCLUSION: Current evidence does not support the use of PBMT to decrease pain and disability in people with non-specific LBP. REGISTRATION: CRD42018088242.

Effects of photobiomodulation therapy on inflammatory mediators in patients with chronic non-specific low back pain: Protocol for a randomized placebo-controlled trial.

INTRODUCTION: Low back pain (LBP) is ranked as one of the most prevalent health conditions. It is likely that some inflammatory mediators could be associated with pain and disability in these patients. Photobiomodulation therapy (PBMT) is a non-pharmacological therapy often used in patients with LBP and one of the possible mechanisms of action of therapy is modulate inflammatory mediators. However, to date there are no studies that evaluated the effects of PBMT on the levels of inflammatory mediators in patients with LBP. The aim of this study is to evaluate the acute effects of PBMT on systemic levels of inflammatory mediators and pain intensity in patients with chronic non-specific low back pain. METHODS AND ANALYSIS: This is a prospectively registered, two-arm randomized placebo-controlled trial with blinded patients, assessors and therapists. Eighteen patients with chronic non-specific LBP will be randomized into 2 groups: placebo or active PBMT. The treatment will be provided in a single session. The primary outcome will be levels of prostaglandin E2 (PGE2). The secondary outcomes will be levels of necrosis factor alpha (TNF-α), interleukin 6 (IL-6) and pain intensity. Biochemical and clinical outcomes will be measured at baseline and 15 minutes after the single treatment session. DISCUSSION: Despite PBMT be used in musculoskeletal disorders such as LBP, to the best of our knowledge this is the first study that will investigate a possible biological mechanism behind the positive clinical effects of PBMT on non-specific chronic low back pain. ETHICS AND DISSEMINATION: The study was approved by the Regional Research Ethics Committee. The results will be disseminated through publication in peer-reviewed international journal and conferences. TRIAL REGISTRATION NUMBER: NCT03859505.

Effectiveness of Kinesio Taping in Patients With Chronic Nonspecific Low Back Pain: A Systematic Review With Meta-analysis.

STUDY DESIGN: Systematic review. OBJECTIVE: To investigate the effects of Kinesio Taping (KT) in patients with nonspecific low back pain. SUMMARY OF BACKGROUND DATA: KT is widely used in patients with low back pain. METHODS: We conducted searches on PubMed, EMBASE, PEDro, SciELO, and LILACS up to February 26, 2018. We included only randomized controlled trials (RCTs) in adults with chronic nonspecific low back pain that compared KT to no intervention or placebo as well as RCTs that compared KT combined with exercise against exercise alone. The methodological quality and statistical reporting of the eligible trials were measured by the 11-item PEDro scale. The quality of the evidence was assessed using the GRADE classification. We considered pain intensity and disability as the primary outcomes. Whenever possible, the data were pooled through meta-analysis. RESULTS: We identified 11 RCTs for this systematic review (pooled n = 743). Two clinical trials (pooled n = 100) compared KT to no intervention at the short-term follow-up. Four studies compared KT to placebo (pooled n = 287) at short-term follow-up and two trials (pooled n = 100) compared KT to placebo at intermediate-term follow-up. Five trials (pooled n = 296) compared KT combined with exercises or electrotherapy to exercises or spinal manipulation alone. No statistically significant difference was found for most comparisons. CONCLUSION: Very low to moderate quality evidence shows that KT was no better than any other intervention for most the outcomes assessed in patients with chronic nonspecific low back pain. We found no evidence to support the use of KT in clinical practice for patients with chronic nonspecific low back pain. LEVEL OF EVIDENCE: 1.

Photobiomodulation therapy for the improvement of muscular performance and reduction of muscular fatigue associated with exercise in healthy people: a systematic review and meta-analysis.

Researches have been performed to investigate the effects of phototherapy on improving performance and reduction of muscular fatigue. However, a great variability in the light parameters and protocols of the trials are a concern to establish the efficacy of this therapy to be used in sports or clinic. The aim of this study is to investigate the effectiveness, moment of application of phototherapy within an exercise protocol, and which are the parameters optimally effective for the improvement of muscular performance and the reduction of muscular fatigue in healthy people. Systematic searches of PubMed, PEDro, Cochrane Library, EMBASE, and Web of Science databases were conducted for randomized clinical trials to March 2017. Analyses of risk of bias and quality of evidence of the included trials were performed, and authors were contacted to obtain any missing or unclear information. We included 39 trials (861 participants). Data were reported descriptively through tables, and 28 trials were included in meta-analysis comparing outcomes to placebo. Meta-analysis was performed for the variables: time until reach exhaustion, number of repetitions, isometric peak torque, and blood lactate levels showing a very low to moderate quality of evidence and some effect in favor to phototherapy. Further investigation is required due the lack of methodological quality, small sample size, great variability of exercise protocols, and phototherapy parameters. In general, positive results were found using both low-level laser therapy and light-emitting diode therapy or combination of both in a wavelength range from 655 to 950 nm. Most of positive results were observed with an energy dose range from 20 to 60 J for small muscular groups and 60 to 300 J for large muscular groups and maximal power output of 200 mW per diode.

Effects of photobiomodulation therapy in patients with chronic non-specific low back pain: protocol for a randomised placebo-controlled trial.

INTRODUCTION: Low back pain (LBP) is one of the largest and most frequent public health problems worldwide. Photobiomodulation therapy (PBMT) is a frequently used non-pharmacological therapy for the treatment of musculoskeletal disorders. However, there is little high-quality scientific evidence that demonstrates the effectiveness of PBMT in the treatment of patients with chronic LBP in the short, medium and long term. Therefore, the objective of this clinical trial is to evaluate the effects of PBMT in patients with chronic non-specific LBP in the short, medium and long term. METHODS AND ANALYSES: This is a prospectively registered, two-arm randomised placebo-controlled trial with blinded patients, assessors and treatment providers. One hundred and forty-eight patients with chronic non-specific LBP will be recruited. Treatment sessions will be provided three times a week for 4 weeks (totaling 12 sessions) with patients receiving either placebo or active PBMT. For ethical reasons, all patients, regardless of treatment allocation, will also receive an information booklet based on 'The Back Book'. Clinical outcomes will be measured at baseline, at the end of treatment, as well as 3, 6 and 12 months after randomisation. The primary outcomes will be pain intensity and disability measured after 12 sessions of treatment. The secondary outcomes will be pain intensity and disability measured at 3, 6 and 12 months after randomisation, in addition to specific disability and global perceived effect in all time points. ETHICS AND DISSEMINATION: The study was approved by the Research Ethics Committee of Universidade Cidade de São Paulo. The results will be disseminated through scientific publications and presentations at national and international scientific meetings. TRIAL REGISTRATION NUMBER: NCT03089424.

Kinesio Taping Does Not Provide Additional Benefits in Patients With Chronic Low Back Pain Who Receive Exercise and Manual Therapy: A Randomized Controlled Trial.

Study Design Randomized controlled trial. Background Many clinical practice guidelines endorse both manual therapy and exercise as effective treatment options for patients with low back pain. To optimize the effects of the treatments recommended by the guidelines, a new intervention known as Kinesio Taping is being widely used in these patients. Objectives To determine the effectiveness of Kinesio Taping in patients with chronic nonspecific low back pain when added to a physical therapy program consisting of exercise and manual therapy. Methods One hundred forty-eight patients with chronic nonspecific low back pain were randomly allocated to receive 10 (twice weekly) sessions of physical therapy, consisting of exercise and manual therapy, or the same treatment with the addition of Kinesio Taping applied to the lower back. The primary outcomes were pain intensity and disability (5 weeks after randomization) and the secondary outcomes were pain intensity, disability (3 months and 6 months after randomization), global perceived effect, and satisfaction with care (5 weeks after treatment). Data were collected by a blinded assessor. Results No between-group differences were observed in the primary outcomes of pain intensity (mean difference, -0.01 points; 95% confidence interval [CI]: -0.88, 0.85) or disability (mean difference, 1.14 points; 95% CI: -0.85, 3.13) at 5 weeks' follow-up. In addition, no between-group differences were observed for any of the other outcomes evaluated, except for disability 6 months after randomization (mean difference, 2.01 points; 95% CI: 0.03, 4.00) in favor of the control group. Conclusion Patients who received a physical therapy program consisting of exercise and manual therapy did not get additional benefit from the use of Kinesio Taping. Level of Evidence Therapy, level 1b. Prospectively registered May 28, 2013 at www.ClinicalTrials.gov (NCT01866332). J Orthop Sports Phys Ther 2016;46(7):506-513. Epub 6 Jun 2016. doi:10.2519/jospt.2016.6590.

Kinesio taping to generate skin convolutions is not better than sham taping for people with chronic non-specific low back pain: a randomised trial.

QUESTION: For people with chronic low back pain, does Kinesio Taping, applied according to the treatment manual to create skin convolutions, reduce pain and disability more than a simple application without convolutions? DESIGN: Randomised trial with concealed allocation, intention-to-treat analysis and blinded assessment of some outcomes. PARTICIPANTS: 148 participants with chronic non-specific low back pain. INTERVENTION: Experimental group participants received eight sessions (over four weeks) of Kinesio Taping applied according to the Kinesio Taping Method treatment manual (ie, 10 to 15% tension applied in flexion to create skin convolutions in neutral). Control group participants received eight sessions (over four weeks) of Kinesio Taping with no tension, creating no convolutions. OUTCOME MEASURES: The primary outcome measures were pain intensity and disability after the four-week intervention. Secondary outcomes were pain intensity and disability 12 weeks after randomisation, and global perceived effect at both four and 12 weeks after randomisation. RESULTS: Applying Kinesio Tape to create convolutions in the skin did not significantly change its effect on pain (MD-0.4 points, 95% CI-1.3 to 0.4) or disability (MD-0.3 points, 95% CI-1.9 to 1.3) at four weeks. There was a small difference in favour of the experimental group for the secondary outcome of global perceived effect (MD 1.4 points, 95% CI 0.3 to 2.5) at four weeks. No significant between-group differences were observed for the other secondary outcomes. CONCLUSION: Kinesio Taping applied with stretch to generate convolutions in the skin was no more effective than simple application of the tape without tension for the outcomes measured. These results challenge the proposed mechanism of action of this therapy. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials, RBR-7ggfkv.

Current evidence does not support the use of Kinesio Taping in clinical practice: a systematic review.

QUESTIONS: Is Kinesio Taping more effective than a sham taping/placebo, no treatment or other interventions in people with musculoskeletal conditions? Is the addition of Kinesio Taping to other interventions more effective than other interventions alone in people with musculoskeletal conditions? DESIGN: Systematic review of randomised trials. PARTICIPANTS: People with musculoskeletal conditions. INTERVENTION: Kinesio Taping was compared with sham taping/placebo, no treatment, exercises, manual therapy and conventional physiotherapy. OUTCOME MEASURES: Pain intensity, disability, quality of life, return to work, and global impression of recovery. RESULTS: Twelve randomised trials involving 495 participants were included in the review. The effectiveness of the Kinesio Taping was tested in participants with: shoulder pain in two trials; knee pain in three trials; chronic low back pain in two trials; neck pain in three trials; plantar fasciitis in one trial; and multiple musculoskeletal conditions in one trial. The methodological quality of eligible trials was moderate, with a mean of 6.1 points on the 10-point PEDro Scale score. Overall, Kinesio Taping was no better than sham taping/placebo and active comparison groups. In all comparisons where Kinesio Taping was better than an active or a sham control group, the effect sizes were small and probably not clinically significant or the trials were of low quality. CONCLUSION: This review provides the most updated evidence on the effectiveness of the Kinesio Taping for musculoskeletal conditions. The current evidence does not support the use of this intervention in these clinical populations. PROSPERO registration: CRD42012003436.

Effects of the carrier frequency of interferential current on pain modulation in patients with chronic nonspecific low back pain: a protocol of a randomised controlled trial.

BACKGROUND: Low back pain is an important public health problem that is associated with poor quality of life and disability. Among the electrophysical treatments, interferential current (IFC) has not been studied in patients with low back pain in a high-quality randomised controlled trial examining not only pain, but pain mechanisms and function. METHODS/DESIGN: A three-arm randomised controlled trial with patient and assessor blinded to the group allocation. One hundred fifty patients with chronic, nonspecific low back pain from outpatient physical therapy clinics in Brazil. The patients will be randomly allocated into 3 groups (IFC 1 kHz, IFC 4 kHz or Placebo IFC). The interferential current will be applied three days per week (30 minutes per session) over four weeks. PRIMARY OUTCOME: Pain intensity. SECONDARY OUTCOMES: The pressure pain threshold, global impression of recovery, disability, function, conditioned pain modulation and temporal summation of pain, discomfort caused by the current. All outcomes will be measured at 4 weeks and 4 months after randomisation. The between-group differences will be calculated by using linear mixed models and Tukey's post-hoc tests. DISCUSSION: The use of a placebo group and double-blinding assessor and patients strengthen this study. The present study is the first to compare different IFC carrier frequencies in patients with chronic low back pain. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials: http://RBR-8n4hg2.

Reproducibility of the pressure biofeedback unit in measuring transversus abdominis muscle activity in patients with chronic nonspecific low back pain.

The Pressure Biofeedback Unit (PBU) is often used by clinicians and researchers to indirectly evaluate transversus abdominis (TrA) muscle activity. The purpose of this study was to evaluate the inter and intra-examiner reproducibility of the PBU in measuring TrA muscle activity in fifty patients with chronic nonspecific low back pain. This study was performed using a test-retest design with a seven day interval. An Intraclass Correlation Coefficient (ICC(2,1)) of 0.74 (95% CI 0.54 to 0.85) and 0.76 (95% CI 0.58 to 0.86) was observed for the intra and inter-examiner reproducibility, respectively. The intra-examiner agreement (Limits of Agreement - LOA = 2.1 to -1.8 mmHg) and the inter-examiner agreement (LOA = 2.0 to -1.9 mmHg) were within the limits of agreement on 95% of occasions. The reproducibility of PBU in measuring TrA muscle activity in patients with chronic nonspecific low back pain ranged from satisfactory to excellent.

Measurement properties of the pressure biofeedback unit in the evaluation of transversus abdominis muscle activity: a systematic review.

BACKGROUND: Measurements from pressure biofeedback units (PBUs) can be used to evaluate the activity of the transversus abdominis (TrA) muscle indirectly. These measurements can classify patients or monitor the progress of treatment programmes for people with low back pain. OBJECTIVE: To systematically review studies on the measurement properties of PBUs for the assessment of TrA activity. DATA SOURCES: Eligible studies were identified through searches of PUBMED, CINAHL and BIREME (1990 to 2009). In addition, hand searches of journals and citation tracking were performed. STUDY SELECTION: Full-text studies involving any type of clinimetric tests of PBU measurement for the assessment of TrA activity were selected. DATA EXTRACTION: Two independent reviewers selected the studies, extracted the data and assessed methodological quality. DATA SYNTHESIS: Due to the heterogeneity of study designs and statistical analysis, it was not possible to pool the data for a meta-analysis. RESULTS: Six studies met the inclusion criteria. These studies were typically of low quality and recruited healthy subjects rather than patients with low back pain. The studies found moderate to good reproducibility (intra-class correlation coefficients from 0.47 to 0.82) and acceptable construct validity (intra-class correlation coefficients from 0.48 to 0.90). CONCLUSIONS: The current evidence about the measurement properties of PBUs for the assessment of TrA activity is mainly based on studies with suboptimal designs, and the findings from these studies are likely to be overly optimistic. The most important clinical questions about the measurement properties of PBUs for the assessment of TrA activity are yet to be answered.