Predictive factors for reporting adverse events following spinal manipulation in randomized clinical trials – secondary analysis of a systematic review

Gorrell, Lindsay M.; Brown, Benjamin T.; Lystad, Reidar P.; Engel, Roger

doi:10.1016/j.msksp.2017.05.002

Cited by 5 publications

(6 citation statements)

References 155 publications

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“…Regarding the increased likelihood of studies reporting on adverse events if spinal manipulation was delivered to multiple/unclear regions, it is possible that this finding is spurious as there was a larger number of studies (n=49) in this category compared with studies in which the intervention was delivered to a single region. This hypothesis is supported by a secondary analysis of our previous review which reported that the region treated was not a significant predictor for reporting on adverse events 56…”

Section: Discussionmentioning

confidence: 64%

“…Specifically, the current review included an improved search strategy, including both an expansion to the number of databases searched (ie, MEDLINE (Ovid), Embase, CINAHL and ICL were added) in addition to the inclusion of several search terms that did not limit the search to spinal manipulation delivered by chiropractors and osteopaths (ie, physiotherapists, naprapaths and medical manipulation were added). Additionally, the current review reports on analyses that we had previously reported separately in two manuscripts: the original review26 and a secondary analysis 56. By reporting these analyses in a single manuscript, we hope it is clearer for readers to identify that the current level of reporting of adverse events associated with spinal manipulation in RCTs is both poor and not consistent with established standards, and understand the possible explanations for this observation.…”

Section: Discussionmentioning

confidence: 99%

“…This hypothesis is supported by a secondary analysis of our previous review which reported that the region treated was not a significant predictor for reporting on adverse events. 56 …”

Section: Discussionmentioning

confidence: 99%

“…Additionally, the current review reports on analyses that we had previously reported separately in two manuscripts: the original review 26 and a secondary analysis. 56 By reporting these analyses in a single manuscript, we hope it is clearer for readers to identify that the current level of reporting of adverse events associated with spinal manipulation in RCTs is both poor and not consistent with established standards, and understand the possible explanations for this observation. By streamlining the dissemination of this information, we hope to make it easier for readers to identify areas in which researchers may improve the reporting of adverse events in this field.…”

Section: Discussionmentioning

confidence: 99%

“…As such, we do not feel this factor had any material influence on our results. Second, as outlined above, small differences in the methodology between the current and previous reviews26 56 mean that it is not possible to directly compare all reported findings between the two reviews. However, as these differences occurred due to methodological improvements in the current review, we do not believe this affected the results and/or discussion in the current review.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2023

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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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Section: Discussionmentioning

confidence: 64%

Section: Discussionmentioning

confidence: 99%

“…This hypothesis is supported by a secondary analysis of our previous review which reported that the region treated was not a significant predictor for reporting on adverse events. 56 …”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

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

et al. 2023

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A methodological review revealed that reporting of trials in manual therapy has not improved over time

Alvarez

Solà

Sitjà-Rabert

et al. 2020

Journal of Clinical Epidemiology

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Short-Term Effect of Spinal Manipulation on the Magnitude of Exophoria in Adults Who Are Asymptomatic: A Randomized Controlled Trial

Fernández-Seguín

Peinado-Asensio²,

Díaz-Mancha

et al. 2023

Physical Therapy

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Objective This study aimed to assess the immediate and short-term effects of cervical spinal manipulation, compared with a placebo, on the magnitude of near and distance exophoria in adults with asymptomatic exophoria. Methods In this single-blind, randomized controlled trial, individuals with a clinical diagnosis of horizontal exophoria confirmed with the prism alternating cover test (PACT) were allocated to a single intervention session using a high-velocity, low-amplitude cervical spinal manipulation technique or a sham intervention (manual contact under the head). Outcomes were the magnitude of horizontal heterophoria, as a measure of binocular vision efficiency at near (40 cm) or distance (4 m) fixation, using the PACT. Evaluations were made at baseline, immediately after intervention, and at a 1-week follow-up. Results From May to September 2021, 44 volunteers (23 women), with a mean age of 35 (SD = 9.5) years, were recruited and equally distributed into the study groups. All participants completed follow-up assessments, and no adverse events were reported. There was a significant time x group interaction for exophoria at near vision, but not at distance fixation. The spinal manipulation group showed a significant decrease of near exophoria compared to the control group at the 1-week follow-up (mean difference = −1.09 prism diopters; 95% CI = −0.20 to −1.98 prism diopters). Conclusion The use of cervical spinal manipulation therapy resulted in a significant reduction of the magnitude of horizontal exophoria at near vision (medium effect size), compared with the placebo, in young adults who are asymptomatic. However, these effects were not observed at distance fixation and should be considered cautiously due to the pre-post design with a single intervention session and the short-term follow-up. Impact The findings suggest short-term benefits of spinal manipulation therapy can manage undiagnosed ocular convergence disorders, although changes were not clinically relevant.

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Predictive factors for reporting adverse events following spinal manipulation in randomized clinical trials – secondary analysis of a systematic review

Cited by 5 publications

References 155 publications

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

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

A methodological review revealed that reporting of trials in manual therapy has not improved over time

Short-Term Effect of Spinal Manipulation on the Magnitude of Exophoria in Adults Who Are Asymptomatic: A Randomized Controlled Trial

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