Evidence map›Paper›PMID 28324697›Full record

Trial reportMusculoskeletal science & practice2017

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

Aleksander Chaibi, Jūratė Šaltytė Benth, Peter J Tuchin, Michael Bjørn Russell

Erratum issued Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Musculoskeletal science & practice, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01741714 (Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option for Migraine? A Randomized Controlled Clinical Trial), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.5field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01741714 nacompletednot on this map

Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option for Migraine? A Randomized Controlled Clinical Trial

TypeinterventionalSponsorUniversity Hospital, AkershusRan2013 to 2015Enrolled104ConditionsMigraine With Aura, Migraine Without AuraArmsSham chiropractic manipulative therapy, Chiropractic spinal manipulative therapy
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 2 countries.

Aleksander ChaibiHead 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.
Jūratė Šaltytė BenthInstitute 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.
Peter J TuchinDepartment of Chiropractic, Macquarie University, NSW, 2109, Australia. Electronic address: peter.tuchin@mq.edu.au.
Michael Bjørn RussellHead 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.
University of Oslo · NOAkershus University Hospital · NOMacquarie University · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUnlike 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.

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

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

methodsSeventy 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.

resultsAEs 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).

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

Indexed as

AdolescentAdultAgedFemaleHumansMaleManipulation, ChiropracticManipulation, SpinalMiddle AgedMigraine DisordersNorwayPainPlacebo EffectSingle-Blind MethodYoung AdultAdverse eventsChiropracticMigraineRandomized controlled trialRCTSide effectsSpinal manipulative therapy

Identifiers

PMID28324697
OpenAlexW2596449026

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.