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A randomised controlled trial of multimodal physiotherapy vs advice for recent onset, painful cervical radiculopathy – The PACeR trial protocol

BMC Musculoskeletal Disorders Jun 07, 2019

Keating L, et al. - In this assessor blinded, superiority, 2 parallel group randomized controlled trial, researchers sought to examine how a 4 week physiotherapy program (6–8 sessions) of manual therapy, exercise and upper limb neural unloading tape vs a control of weekly phone advice, affects disability, pain and selected biopsychosocial measures, in acute and sub-acute cervical radiculopathy patients. Further, they sought for baseline variables, symptom duration or group allocation that can predict outcome. From General Practitioners referrals in an urban setting, from a neurosurgery non-urgent waiting list and from self-referral through Facebook advertising, they recruit 64 eligible participants. They will use random 1:1 group allocation (using variable block sizes), allocation concealment, blinded assessment and intention to treat analysis. Clinical specialist physiotherapists in primary and secondary care settings provided the treatment. At baseline, 4 (primary endpoint) and 12 weeks, measurement of outcomes are performed. Via telephone interview at 6 months, they recorded participants’ report of pain, disability and their rating of recovery. Using ANOVAs and MANOVAs, they will perform statistical analysis of between group differences, and via performing multivariable regression analysis, predictor variables will be explored. The trial expansion was done in view of an internal pilot study to test retention and recruitment strategies and now this is a multi center trial involving 5 clinical sites.
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