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Musculoskelet Sci Pract. 2017 Jun;29:66-71. doi: 10.1016/j.msksp.2017.03.003. Epub 2017 Mar 14.

Adverse events in a chiropractic spinal manipulative therapy single-blinded, placebo, randomized controlled trial for migraineurs.

Author information

1
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.
2
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.
3
Department of Chiropractic, Macquarie University, NSW, 2109, Australia. Electronic address: peter.tuchin@mq.edu.au.
4
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.

Abstract

BACKGROUND:

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.

OBJECTIVE:

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

DESIGN:

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

METHODS:

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.

RESULTS:

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).

CONCLUSIONS:

AEs were mild and transient, and severe or serious AEs were not observed.

KEYWORDS:

Adverse events; Chiropractic; Migraine; RCT; Randomized controlled trial; Side effects; Spinal manipulative therapy

PMID:
28324697
DOI:
10.1016/j.msksp.2017.03.003
[Indexed for MEDLINE]
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