Co-developed neck exercise (EPIC-Neck) versus usual exercise care for people with chronic non-specific neck pain: a UK multicentre randomised feasibility trial
Open Access
Abstract
Objectives To assess the feasibility of conducting a definitive randomised controlled trial of the EPIC-Neck progamme versus usual exercise care for chronic non-specific neck pain, specifically in relation to recruitment, retention, delivery fidelity, acceptability and contamination. Design Multicentre, two-arm, parallel-group, individually randomised controlled feasibility trial with an embedded process evaluation. Setting Three National Health Service musculoskeletal services in England. Participants Adults (≥18 years) with chronic non-specific neck pain lasting >3 months. Interventions Participants were randomised (2:1) to EPIC-Neck (an individualised, evidence-based, theory informed, co-designed exercise programme) or usual exercise care. Participants and outcome assessors were not blinded to allocation. Feasibility objectives Progression was assessed using predefined green–amber–red criteria across five domains: (1) recruitment rate, (2) retention rate (percentage returning the neck disability index at 6 months), (3) delivery fidelity (audio-recorded appointments scored on a 0–5 Dreyfus competence scale where ≥3 means acceptable), (4) acceptability to participants and physiotherapists (1–5 acceptability questionnaires where ≥4 means acceptable and interviews analysed deductively using framework analysis against the theoretical framework of acceptability) and (5) contamination (presence of EPIC-Neck components in usual care) scored using the same 0–5 Dreyfus competency scale as delivery fidelity. Results Between May 2024 and February 2025, 287 individuals were screened and 36 were randomised (24 EPIC-Neck, 12 usual care), yielding a mean recruitment rate of 4.5 participants/month (green). Retention at 6 months was 67% (24/36) (red). Among participants who completed their allocated treatment, the 6-month retention rate was 91% (22/24). Delivery fidelity was moderate (mean 2.4/5; amber), with only 14% of participants receiving EPIC-Neck at an acceptable level. Acceptability was generally positive, although interviews identified addressable concerns around intervention coherence (amber). Contamination was low (mean fidelity score for controls was 1.1/5; green). Conclusions EPIC-Neck shows potential for evaluation in a definitive trial, but progression is conditional on future refinement of the intervention and study procedures to address the key barriers to progression: retention, delivery fidelity and intervention coherence. Trial registration number ISRCTN81746901Keywords
Funding Information
- National Institute for Health and Care Research (Clinical Doctoral Research Fellow, NIHR302141)
This publication has 89 references indexed in Scilit:
- Retention rates and reasons for non-retention in exercise oncology trials in the post-treatment phase—a systematic reviewJournal of Cancer Survivorship, 2024
- The clinical course of neck pain: Are trajectory patterns stable over a 1‐year period?European journal of pain, 2021
- Contamination: How much can an individually randomized trial tolerate?Statistics in Medicine, 2021
- Psychometric properties of the EQ-5D-5L: a systematic review of the literatureQuality of Life Research, 2020
- Visual trajectory pattern as prognostic factors for neck painEuropean journal of pain, 2020
- Training Physical Therapists in Person‐Centered Practice for People With Osteoarthritis: A Qualitative Case StudyArthritis Care & Research, 2018
- Deriving population norms for the AQoL-6D and AQoL-8D multi-attribute utility instruments from web-based dataQuality of Life Research, 2016
- Exercises for mechanical neck disordersCochrane Database of Systematic Reviews, 2015
- Validity and Reliability of the Assessment of Quality of Life (AQoL)-8D Multi-Attribute Utility InstrumentThe Patient - Patient-Centered Outcomes Research, 2013
- The pain self‐efficacy questionnaire: Taking pain into accountEuropean journal of pain, 2007