Adverse events in a chiropractic spinal manipulative therapy single-blinded, placebo, randomized controlled trial for migraineurs.
Unlike pharmacological randomized controlled trials (RCTs), manual-therapy RCTs do not always report adverse events (AEs). The few manual-therapy RCTs that provide information on AEs are frequently without details, such as the type and-, severity of the AE and reason for withdrawal.



To prospectively report all AEs in a chiropractic spinal manipulative therapy (CSMT) RCT.



A prospective 3-armed, single-blinded, placebo, RCT.



Seventy migraineurs were randomized to the CSMT or a placebo, with 12 intervention sessions over three months. The recommendations by CONSORT and the International Headache Society's Task Force on AEs in migraine RCTs were followed. A standardized reporting scheme designed for pharmacological RCTs was used, and the AEs were described as frequencies and percentages within each group. The 95% confidence intervals (CIs) for the percentages (absolute risk) of AEs in each group were calculated when possible. Attributable risk (%) and relative risk were calculated with the corresponding 95% CIs.



AEs were assessed in 703 sessions, with 355 in the CSMT group and 348 in the placebo group. Local tenderness was the most common AE, reported by 11.3% and 6.9% of the CSMT group and the placebo group, respectively, and tiredness on the intervention day was reported by 8.5% and 1.4% of CSMT group and the placebo group, respectively. The highest attributable risk was for tiredness on the treatment day, 7.0% (CI 3.9-10.2%) which presented a relative risk of 5.9 (CI 2.3-15.0).



AEs were mild and transient, and severe or serious AEs were not observed.
Head and Neck Research Group, Research Centre, Akershus University Hospital, 1478, Lørenskog, Oslo, Norway; Institute of Clinical Medicine, Campus Akershus University Hospital, University of Oslo, 1474, Nordbyhagen, Oslo, Norway. Electronic address: aleksander.chaibi@medisin.uio.no.
Aleksander
A
Chaibi
Institute of Clinical Medicine, Campus Akershus University Hospital, University of Oslo, 1474, Nordbyhagen, Oslo, Norway; HØKH, Research Centre, Akershus University Hospital, 1478, Lørenskog, Oslo, Norway. Electronic address: jurate.saltyte-benth@medisin.uio.no.
Jūratė Šaltytė
JŠ
Benth
Department of Chiropractic, Macquarie University, NSW, 2109, Australia. Electronic address: peter.tuchin@mq.edu.au.
Peter J
PJ
Tuchin
Head and Neck Research Group, Research Centre, Akershus University Hospital, 1478, Lørenskog, Oslo, Norway; Institute of Clinical Medicine, Campus Akershus University Hospital, University of Oslo, 1474, Nordbyhagen, Oslo, Norway. Electronic address: m.b.russell@medisin.uio.no.
Michael Bjørn
MB
Russell
D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D026882:Manipulation, Chiropractic / Q000009:adverse effects* / Q000379:methods*; D020393:Manipulation, Spinal / Q000009:adverse effects* / Q000379:methods*; D008875:Middle Aged; D008881:Migraine Disorders / Q000628:therapy*; D009664:Norway; D010146:Pain / Q000209:etiology*; D015990:Placebo Effect; D016037:Single-Blind Method; D055815:Young Adult
Adverse events; Chiropractic; Migraine; RCT; Randomized controlled trial; Side effects; Spinal manipulative therapy