Background: Feasibility and pilot studies are recommended prior to embarking on large-scale costly confirmatory trials. The objectives were to determine the feasibility of conducting a cluster randomized controlled trial (C-RCT) to evaluate a complex knowledge translation (KT) intervention to improve the management of people with neck pain, and to identify challenges and potential solutions to conducting a fully powered C-RCT in the chiropractic setting.
Methods: Pilot C-RCT involving a nationally representative sample of chiropractors and patients. We invited 400 chiropractors and 150 patients to participate. Clinicians were randomized to receive either an online theory-based KT educational and brief action plan (BAP) intervention (intervention group) or a copy of a clinical practice guideline (control group). Study-related challenges were ascertained via mid-study phone interviews and end-of-study feedback questionnaires. Analyses focused on descriptive estimates of likely recruitment, retention, and adherence rates, and documentation of potential barriers.
Results: In total, 47 chiropractors (12%) agreed to participate and were randomized after resampling. Fifteen withdrew from the study, leaving a total of 32 (8%) participants. Eleven chiropractors in the intervention group completed the webinars and e-learning modules, two partially completed them and three did not register. Participating chiropractors recruited a total of 29 patients. Sixty-three percent (n = 7) of intervention and 56% (n = 10) of control group patients completed all outcome measures at both baseline and 3-months follow-up, attended follow-up visits and performed home exercises. Patients in the intervention group reported significant reductions in pain (mean 1.6, 95% CI 0.26–2.94, P = 0.027) and disability scores (9.8, 95% CI 3.68–15.91, P = 0.033) from baseline to 3-month follow-up. Key barriers to participation reported by chiropractors included lack of time, difficulties in recruiting patients, problems with the administration of study questionnaires, concern that the clinician-patient relationship might be jeopardized, and lack of assistance from office staff. Over half (55%) of the respondents in the intervention group encountered some difficulty registering or completing the educational modules.
Conclusion: Recruitment of clinicians and patients for a trial of a complex intervention can be challenging, and retention of participants after enrolment may be low. Future trials of this nature likely require multiple recruitment strategies to achieve desired sample sizes. Moreover, time-constraint issues are perceived particularly by clinicians as a major barrier to both study enrolment before, and protocol adherence during, their actual participation in a trial.
Trial registration: The study was registered at, NCT02483091, on 17th June 2015.
Author keywords: Chiropractic — Knowledge translation — Randomized controlled trial — Pilot projects — Feasibility studies — Recruitment — Retention — Adherence — Multifaceted intervention — Interviews
Author affiliations: PD, AB: School of Physical and Occupational Therapy, Faculty of Medicine, McGill University, Montreal, Quebec, Canada; PD, AB: Centre de recherche interdisciplinaire en réadaptation (CRIR), Montréal,Quebec, Canada; SDF: Department of Chiropractic, Macquarie University, Eastwood, New South Wales, Australia; JAQ: School of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; JAQ: International Collaboration on Repair Discoveries (ICORD), Vancouver Coastal Health Research Institute, Vancouver; JAQ: Spine Program, Department of Orthopaedics, Faculty of Medicine, University of British Columbia, Vancouver; JAQ: The Cambie Chiropractic Centre, Vancouver; HO: CISSS Laval-Jewish Rehabilitation Hospital, Laval, Quebec, Canada; AB: Département chiropratique, Université du Québec à Trois-Rivières, Trois-Rivières, Quebec, Canada
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