Abstract
BackgroundA research gap exists for optimal management of cervical radiculopathy in the first 12 weeks and short term natural history of the condition is somewhat unclear, although thought to be favourable. The primary aim of this assessor blinded, superiority, 2 parallel group randomised controlled trial is to investigate the effects of a 4 week physiotherapy programme (6–8 sessions) of manual therapy, exercise and upper limb neural unloading tape, compared to a control of weekly phone advice; on disability, pain and selected biopsychosocial measures, in acute and sub-acute cervical radiculopathy patients. A secondary aim is to identify whether any baseline variables, symptom duration or group allocation can predict outcome.MethodsParticipants are recruited from GP referrals in an urban setting, from a neurosurgery non-urgent waiting list and from self-referral through Facebook advertising. Eligible participants (n = 64) are diagnosed with radiculopathy based on a clinical prediction rule and must have symptoms of unilateral, single level, radiculopathy for between 2 and 12 weeks, without having yet received physiotherapy. Random 1:1 group allocation (using variable block sizes), allocation concealment, blinded assessment and intention to treat analysis are being employed. Treatment is provided by clinical specialist physiotherapists in primary and secondary care settings. Outcomes are measured at baseline, 4 (primary endpoint) and 12 weeks. Participants’ report of pain, disability and their rating of recovery is also recorded by telephone interview at 6 months. Statistical analysis of between group differences will be performed with ANOVAs and MANOVAs, and multivariable regression analysis will be undertaken to explore predictor variables. Ethical approval for this study has been received from the Beaumont Hospital and Irish College of General Practitioners Research Ethics Committees. The trial is registered at ClinicalTrials.gov (NCT02449200).DiscussionAn internal pilot study to test retention and recruitment strategies led to trial expansion and this is now a multi centre trial involving 5 clinical sites.Trial registrationNCT02449200. Registered 20/05/15.
Highlights
A research gap exists for optimal management of cervical radiculopathy in the first 12 weeks and short term natural history of the condition is somewhat unclear, thought to be favourable
Cervical radiculopathy (CR) has been defined by the North American Spine Society (NASS) as pain in a radicular pattern in one or both upper extremities related to compression and/or irritation of one or more cervical nerve roots, with signs and symptoms including varying degrees of sensory, motor, and reflex changes in addition to dysaesthesia and paraesthesia [1]
Ten years have passed since the Taskforce on Neck Pain highlighted the existence of a research gap for its optimal management [5], during the World Health Organisation’s (WHO) Bone and Joint Decade (2000–10); and several clinical guidelines exist for CR management [1, 3, 6, 7], they often rely heavily on consensus and have universally highlighted the paucity of high quality, randomised controlled trials
Summary
Study design The PACeR trial is an exploratory, two parallel group, assessor-blinded, multi-centre randomised controlled trial, with a primary endpoint of pain and disability at 4 weeks. In addition to these outcome measures, baseline demographics including co-morbidities, educational level, smoking status, occupation and work status will be captured; with change in work status noted at subsequent time points Medication use for both groups is recorded weekly over the first month by physiotherapists and by the PI at follow up assessments. An MCID for the NPRS of 2 has been determined for mechanical neck pain, including cervical radiculopathy [43] and a SD of 1.85 [48] Using these figures, with a two-sided 5% significance level and a power of 80%, a sample size of 15 per group was calculated. Appropriate multivariable regression analysis will be performed (linear or logistic)
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