Reporting of adverse events associated with spinal manipulation in randomised clinical trials: an updated systematic review

被引:1
作者
Gorrell, Lindsay M. [1 ,2 ]
Brown, Benjamin T. [3 ]
Engel, Roger [3 ]
Lystad, Reidar P. [4 ]
机构
[1] Univ Hosp Balgrist, Dept Chiropract Med, Integrat Spinal Res Grp, Zurich, Switzerland
[2] Univ Zurich, Zurich, Switzerland
[3] Macquarie Univ, Fac Med Hlth & Human Sci, Dept Chiropract, Sydney, NSW, Australia
[4] Macquarie Univ, Australian Inst Hlth Innovat, Fac Med Hlth & Human Sci, Sydney, NSW, Australia
来源
BMJ OPEN | 2023年 / 13卷 / 05期
关键词
back pain; musculoskeletal disorders; spine; adverse events; clinical trials; rehabilitation medicine; LOW-BACK-PAIN; ARTERIAL DISSECTIONS; CHIROPRACTIC CARE; NECK PAIN; MANAGEMENT; THERAPY; STROKE; QUALITY; SAFETY; ADULTS;
D O I
10.1136/bmjopen-2022-067526
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
ObjectivesTo describe if there has been a change in the reporting of adverse events associated with spinal manipulation in randomised clinical trials (RCTs) since 2016.DesignA systematic literature review.Data sourcesDatabases were searched from March 2016 to May 2022: MEDLINE (Ovid), Embase, CINAHL, ICL, PEDro and Cochrane Library. The following search terms and their derivatives were adapted for each platform: spinal manipulation; chiropractic; osteopathy; physiotherapy; naprapathy; medical manipulation and clinical trial.MethodsDomains of interest (pertaining to adverse events) included: completeness and location of reporting; nomenclature and description; spinal location and practitioner delivering manipulation; methodological quality of the studies and details of the publishing journal. Frequencies and proportions of studies reporting on each of these domains were calculated. Univariable and multivariable logistic regression models were fitted to examine the effect of potential predictors on the likelihood of studies reporting on adverse events.ResultsThere were 5399 records identified by the electronic searches, of which 154 (2.9%) were included in the analysis. Of these, 94 (61.0%) reported on adverse events with only 23.4% providing an explicit description of what constituted an adverse event. Reporting of adverse events in the abstract has increased (n=29, 30.9%) while reporting in the results section has decreased (n=83, 88.3%) over the past 6 years. Spinal manipulation was delivered to 7518 participants in the included studies. No serious adverse events were reported in any of these studies.ConclusionsWhile the current level of reporting of adverse events associated with spinal manipulation in RCTs has increased since our 2016 publication on the same topic, the level remains low and inconsistent with established standards. As such, it is imperative for authors, journal editors and administrators of clinical trial registries to ensure there is more balanced reporting of both benefits and harms in RCTs involving spinal manipulation.
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