A Randomised Controlled Trial of Multimodal Physiotherapy for Patients with Acute / Sub-acute Cervical Radiculopathy – the PACeR trial protocol

Objectives: Multimodal physiotherapy involving manual therapy and exercise has demonstrated a positive effect on pain and disability in sub-acute and chronic cervical radiculopathy (CR) (Boyles et al., 2011) but a research gap... [ view full abstract ]

Objectives: Multimodal physiotherapy involving manual therapy and exercise has demonstrated a positive effect on pain and disability in sub-acute and chronic cervical radiculopathy (CR) (Boyles et al., 2011) but a research gap exists for optimal management in the first 12 weeks. CR is of particular clinical concern, given the higher levels of pain and disability associated with the presence of nerve-related arm pain resulting in higher healthcare costs for this cohort of people with neck pain (Haldeman et al., 2008). The primary aim of this single blind, 2 parallel group randomised controlled, superiority trial is to investigate the effects of a 4 week (6-8 sessions) programme of manual therapy, exercise and upper limb neural unloading tape compared to weekly phone calls of advice to stay active, on disability (NDI), pain (NPRS) and other biopsychosocial measures (including neck ROM, pressure pain threshold, SF 12v2, HADS, FABQ and GROC scales), in acute / sub-acute cervical radiculopathy patients.  A secondary objective is to identify whether baseline variables, group allocation and aetiology confirmed by MRI can predict outcome.  Methods: Eligible participants (n=64) are diagnosed with CR based on a clinical prediction rule and must have symptoms of unilateral, single-level, radiculopathy for between 2 and 12 weeks, without having yet attended physiotherapy. Participants are recruited directly from GPs in Dublin north and south and from non-urgent neurosurgery waiting lists in the National Neurosurgical Centre. Random 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 the National Neurosurgical Centre and 4 private physiotherapy practices across Dublin. Outcomes are measured at baseline, 4 (primary endpoint) and 12 weeks. Participants’ report of pain, disability and their rating of recovery are recorded by telephone interview at 6 months.   Results (preliminary): An internal pilot study to test recruitment and retention strategies has been undertaken and directly led to expansion of the trial across Dublin to enhance recruitment. Statistical analysis of between group differences will be performed with ANOVAs and MANOVAs and regression analysis will be undertaken to explore predictor variables.  Conclusion: This Eurospine-funded trial is registered at ClinicalTrials.gov (NCT02449200) and currently enrolling with 24/64 participants recruited and no losses to follow up at primary endpoint. Retention strategies have proven effective to date but recruitment is challenging.  Ethical Approval: Ethical approval for this study has been received from the Beaumont Hospital and Irish College of General Practitioners (ICGP) Research Ethics Committees.