Non-specific neck pain Musculoskeletal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients: 1. Adults with CNP pain duration >3 months and considered at high risk of poor long-term outcome (identified with STarT MSK tool) 2. Currently scoring 4 or more on a numerical response scale for pain from 0-10 (0 = no pain, 10 = worst pain) 3. Ability to stand for 10 minutes (required to complete the intervention) 4. Speak and understand English sufficiently to read the information sheet and sign the consent form Physiotherapist: Band 7 physiotherapist (or above) with at least 3 years experience of managing patients with long-term pain.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis) 2. Previous spinal surgery such as discectomy, anterior cervical discectomy and fusion, disc replacement, laminectomy and scoliosis fixation 3. Diagnosis of degenerative neurological disorders (e.g. multiple sclerosis/Parkinson's) 4. Vulnerable patients for example those who lack the mental capacity to make decisions, have dementia or are nearing the end of life 5. BMI of more than 33 (as increased subcutaneous fat prevents the collection of surface EMG signals) 6. Pending litigation related to an injury for example at work or whilst driving 7. Unable to cancel or postpone other treatment that is being received for the condition, for example, physiotherapy, chiropractic or osteopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As this is a feasibility study the primary outcome is related to establishing the feasibility of a future large-scale clinical trial: 1. The average number of participants screened, consented and randomised per month 2. Adherence and retention to the study determined by calculating the average number of sessions attended by participants 3. Optimal outcome measure questionnaires determined by calculating the percentage of participants providing 14-week and 6-month data 4. The acceptability of the intervention to patients determined via qualitative interviews at 14 weeks The following stop-go criteria will be assessed prior to planning a future large-scale trial: 1. Recruitment: average participants recruited per month: red: 6 per month 2. Adherence/retention: participants attending >5 (of 7) clinical sessions: <60%; amber = 60-79%; green =80% 3. Outcomes: participants providing 14-week and 6-month data: red <60%; amber = 60-79%; green =80%. The appropriateness of outcomes is determined via qualitative evaluation 4. Acceptability to patients determined via the qualitative evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disability measured using the Neck Disability Index (NDI) at 14 weeks and 6 months 2. Pain measured using the Numerical rating scale of pain scale (0-10) at 14 weeks and 6 months 3. Kinesiophobia measured using the 13-item Tampa Scale of Kinesiophobia (TSK- 13) at 14 weeks and 6 months 4. Catastrophising measured using the Pain Catastrophising Scale (PCS) at 14 weeks and 6 months 5. Quality of life measured using the EQ-5D-5L (EuroQol) at 14 weeks and 6 months 6. Risk of chronic pain measured using the STarT MSK Screening Tool at 14 weeks and 6 months 7. Healthcare interactions measured using the Healthcare utilisation questionnaire at 14 weeks and 6 months | — |
Countries
England, United Kingdom