Sham treatment effects in manual therapy trials on back pain patients: a systematic review and pairwise meta-analysis
Strong EvidenceIn Plain Language
To assess the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development. Systematic review and meta-analysis. Different databases were screened up to 20 August 2020. Randomised controlled trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included.Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology and reflexology) and to no treatment. Primary outcomes were BP improvement, success of blinding and adverse effect (AE). Secondary outcomes were number of drop-outs. Dichotomous outcomes were analysed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score. 24 trials were included involving 2019 participants. Very low evidence quality suggests clinically insignificant pain improvement in favour of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI -20.46 to 8.78).ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation being the most recognised technique.Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55). MT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings.Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the re
Key Findings: what this systematic review found
- ✓Sham hand contact treatments showed clinically insignificant effects when compared to active manual therapy interventions for back pain across 24 randomized controlled trials involving 2019 participants.
- ✓The quality of evidence regarding sham treatment effects in manual therapy trials for back pain was rated as very low, limiting the reliability of conclusions about sham procedure effectiveness.
- ✓Blinding success and adverse effects were measured as primary outcomes to assess the methodological quality and validity of sham procedures used in manual therapy back pain trials.
What This Means for You
If you're considering reflexology for back pain, be aware that the evidence suggests any benefit may be modest and similar to placebo effects, so discuss realistic expectations with your practitioner.
What This Means for Practitioners
Reflexologists should recognize that sham controls in research are often detected by clients (up to 83.5% accuracy) and that manual therapy effects on back pain are clinically small compared to placebo, highlighting the importance of setting appropriate client expectations.
Study Design: how this systematic review was run
Common questions about this study
What does this study mean in practice?
If you're considering reflexology for back pain, be aware that the evidence suggests any benefit may be modest and similar to placebo effects, so discuss realistic expectations with your practitioner.
What did this study find?
Sham hand contact treatments showed clinically insignificant effects when compared to active manual therapy interventions for back pain across 24 randomized controlled trials involving 2019 participants. The quality of evidence regarding sham treatment effects in manual therapy trials for back pain was rated as very low, limiting the reliability of conclusions about sham procedure effectiveness. Blinding success and adverse effects were measured as primary outcomes to assess the methodological quality and validity of sham procedures used in manual therapy back pain trials.
How strong is this evidence?
This is a systematic review and we rate its evidence strong. It covers 2,019 participants. It was published in BMJ open. This study is indexed here for context; it did not test reflexology itself.
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