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Abstract
Objective 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.
Design Systematic review and meta-analysis.
Methods and 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.
Results 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).
Conclusions 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 reliable detection of clinically meaningful treatment effects.
PROSPERO registration number CRD42020198301.
- complementary medicine
- statistics & research methods
- back pain
Data availability statement
Data are available in a public, open access repository. Data are available on reasonable request. Data may be obtained from a third party and are not publicly available. All data relevant to the study are included in the article or uploaded as online supplemental information. Details of the characteristics of the included studies and data extracted are available from the corresponding author at carolina.lavazza@docenti.aimoedu.it. Extra data can be accessed via the Dryad data repository at http://datadryad.org/withthedoi:10.5061/dryad.v9s4mw6tb.
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Data availability statement
Data are available in a public, open access repository. Data are available on reasonable request. Data may be obtained from a third party and are not publicly available. All data relevant to the study are included in the article or uploaded as online supplemental information. Details of the characteristics of the included studies and data extracted are available from the corresponding author at carolina.lavazza@docenti.aimoedu.it. Extra data can be accessed via the Dryad data repository at http://datadryad.org/withthedoi:10.5061/dryad.v9s4mw6tb.
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Footnotes
Contributors CL conceived the idea of this review and designed the study with the contribution of MG who also helped in literature search and in the interpretation of study findings. CL and MG revised studies, performed data extraction and analysis and wrote this review. AA and AM provided clinical and technical support, reviewed the manuscript and helped in publication and with the clinical interpretation of study findings. CL is the guarantor of this paper. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. Patients and public were not involved in this project.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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