dc.date.accessioned | 2017-09-04T09:01:29Z | |
dc.date.available | 2017-09-04T09:01:29Z | |
dc.date.issued | 2017 | |
dc.identifier.uri | http://hdl.handle.net/10852/57760 | |
dc.description.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. | en_US |
dc.language.iso | en | en_US |
dc.relation.ispartof | Chaibi, Aleksander (2017) Chiropractic spinal manipulative therapy for migraine. Doctoral thesis. http://urn.nb.no/URN:NBN:no-60486 | |
dc.relation.uri | http://urn.nb.no/URN:NBN:no-60486 | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.title | Adverse events in a chiropractic spinal manipulative therapy single-blinded, placebo, randomized controlled trial for migraineurs | en_US |
dc.type | Journal article | en_US |
dc.creator.author | Chaibi, Aleksander | |
dc.creator.author | Benth, Jūratė Šaltytė | |
dc.creator.author | Tuchin, Peter J. | |
dc.creator.author | Russell, Michael Bjørn | |
dc.identifier.jtitle | Musculoskeletal Science and Practice | |
dc.identifier.volume | 29 | |
dc.identifier.startpage | 66 | |
dc.identifier.endpage | 71 | |
dc.identifier.doi | https://doi.org/10.1016/j.msksp.2017.03.003 | |
dc.identifier.urn | URN:NBN:no-60485 | |
dc.type.document | Tidsskriftartikkel | en_US |
dc.type.peerreviewed | Peer reviewed | |
dc.identifier.fulltext | Fulltext https://www.duo.uio.no/bitstream/handle/10852/57760/1/1-s2.0-S2468781217300541-main.pdf | |
dc.type.version | PublishedVersion | |