Chronic non-specific neck pain Musculoskeletal Diseases
Conditions
Interventions
People with neck pain have been involved in designing this study, reviewing study documentation and co-producing the EPIC-Neck intervention.
People with neck pain will be recruited from NHS musculosk
Sponsors
Birmingham Community Healthcare NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Chronic non-specific neck pain (>3 months) 2. Aged >=18 years old 3. Willing and able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Received physiotherapy, chiropractic or osteopathic treatment (exercise, manual therapy, acupuncture etc) for neck pain in the past 6 months 2. Previous cervical spine surgery 3. Neck pain due to trauma (e.g., whiplash-associated disorders) 4. Neck pain due to a specific diagnosis (e.g., rheumatoid arthritis, osteoarthritis) 5. Presence or suspicion of neurological involvement (e.g., cervical radiculopathy or cervical myelopathy) 6. Presence or suspicion of serious pathology requiring onward referral 7. Headache as the primary complaint 8. Unable to understand or follow study procedures with support from family members or professional interpreters
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome aim of this study is to determine whether to continue to a large-scale definitive trial using pre-specified criteria. The researchers are primarily interested in whether 1. The EPIC-Neck intervention is delivered as intended (delivery fidelity), measured by EPIC-Neck appointment audio recordings and observations scored against a fidelity checklist at the study end 2. The EPIC-Neck programme and usual care exercise are sufficiently different (contamination), measured by usual exercise care appointment audio recordings and observations scored against a fidelity checklist and physiotherapist at the study end 3. The degree to which people delivering and receiving the EPIC-Neck programme consider it to be appropriate (acceptability), measured using an acceptability questionnaire at 3 and 6 months and EPIC-Neck participant interviews at 4 months, and interviews with physiotherapists delivering the EPIC-Neck programme after the majority of treatment has been completed. 4. The mean rate of recruitment per month (mean recruitment rate), measured using study monitoring data at treatment completion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety of the intervention measured using an adverse event case report form during the study 2. The inclusivity of the recruitment procedures measured using the Participant Screening and Recruitment log at the study end 3. Usual exercise care defined using appointment audio recordings and interviews with physiotherapists at the study end 4. Completeness of the planned definitive trial outcome measures at 6-month follow-up The planned definitive trial outcome measures collected as part of this feasibility study are: 1. Neck pain related disability measured using the Neck Disability Index at baseline, 3 and 6 months 2. Neck pain measured using the Visual analogue scale at baseline, 3 and 6 months 3. Health-related quality of life measured using the EQ-5D-5L at baseline, 3 and 6 months 4. Mental Well-being measured using the Hospital Anxiety and Depression at baseline, 3 and 6 months 5. Sleep quality measured using The sleep condition indicator at baseline, 3 and 6 months 6. Specific functional or activity limitations measured using the patient-specific functional scale at baseline, 3 and 6 months 7. Social and relationship impact measured using the relationship and self-worth domains of assessment of quality of life (AQoL 8D) at baseline, 3 and 6 months 8. Pain beliefs measured using the Single item survey of pain attitudes questionnaire at baseline, 3 and 6 months 9. Pain-related fear measured using the Tampa scale of kinesiophobia at baseline, 3 and 6 months 10. Pain self-efficacy measured using the pain self-efficacy questionnaire at baseline, 3 and 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed