Objective: To determine whether treatment with spinal manipulative therapy (SMT) administered in addition to standard care is associated with clinically relevant early reductions in pain and analgesic consumption.
Methods: 104 patients with acute low back pain were randomly assigned to SMT in addition to standard care (n = 52) or standard care alone (n = 52). Standard care consisted of general advice and paracetamol, diclofenac or dihydrocodeine as required. Other analgesic drugs or non-pharmacological treatments were not allowed. Primary outcomes were pain intensity assessed on the 11-point box scale (BS-11) and analgesic use based on diclofenac equivalence doses during days 1–14. An extended follow-up was performed at 6 months.
Results: Pain reductions were similar in experimental and control groups, with the lower limit of the 95% CI excluding a relevant benefit of SMT (difference 0.5 on the BS-11, 95% CI −0.2 to 1.2, p = 0.13). Analgesic consumptions were also similar (difference −18 mg diclofenac equivalents, 95% CI −43 mg to 7 mg, p = 0.17), with small initial differences diminishing over time. There were no differences between groups in any of the secondary outcomes and stratified analyses provided no evidence for potential benefits of SMT in specific patient groups. The extended follow-up showed similar patterns.
Conclusions: SMT is unlikely to result in relevant early pain reduction in patients with acute low back pain.
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PJ and MB contributed equally to this paper
Funding The trial was funded by a grant from the Swiss Society for Manual Therapy to PMV, and intramural funds from the Department of Rheumatology and Clinical Immunology to PMV, from the Institute of Social and Preventive Medicine and CTU Bern to PJ and from mediX practice network to MB. PJ was a PROSPER senior research fellow funded by the Swiss National Science Foundation (grant nos 3233-066377 and 3200-066378) and SR was the recipient of an educational grant by the Swiss Society of Rheumatology. CTU Bern is supported by the Swiss National Science Foundation. The sponsors had no role in the analysis and interpretation of the data or the decision to submit the manuscript. The corresponding author had full access to all data of the trial and had final responsibility for the decision to submit for publication.
Competing interests Declared. PMV, GH, H-RZ and SR are members of the Swiss Society for Manual Therapy and RvB is a member of the Swiss Federation of Osteopathy.
Ethics approval The trial was conducted in accordance with the Declaration of Helsinki and was approved by the research ethics committee of the Canton of Bern.
Patient consent Obtained.