Persistent non-cancer pain Signs and Symptoms
Conditions
Interventions
Participating practices will identify adults 18 years and over who have been prescribed any opioid medicines for persistent non-cancer pain continuously for 6 months or longer and have been issued a p
Sponsors
Keele University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients aged =18 years 2. Prescribed any opioid analgesic (defined as any opioid or opioid/paracetamol combination analgesic from sections 4.7.2 and 4.7.1 British National Formulary [BNF]) for chronic non-cancer pain continuously for =6 months 3. Prescription issued within the previous 2 months
Exclusion criteria
Exclusion criteria: 1. Patients being treated for acute pain (self-limiting pain, for example after injury or surgery), pain associated with cancer and patients with terminal illness (life expectancy <6 months) 2. Vulnerable patients (e.g. severe mental illness, learning difficulties, dementia) 3. Patients currently receiving treatment for substance misuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in opioid use (binary outcome defined as a participant who achieved at least a 25% reduction in opioid use from their baseline Yes/No), measured by self-report questionnaire at baseline, 3, 6 and 12 months 2. Non-inferiority of the Brief Pain Inventory total score, measured by self-report questionnaire at baseline, 3, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain severity/interference measured using the Brief Pain Inventory (BPI) Total Score at 3 and 6 months self-report questionnaire 2. Pain severity, assessed using the BPI pain severity subscale (four items; current, least, worst, and average pain rated on 0-10 scale), at baseline, 3, 6 and 12 months self-report questionnaire 3. Pain-related interference, assessed using the BPI interference subscale (seven items assessing interference with general activity, walking, sleep, work, mood, enjoyment of life and relationships rated on a 0-10 scale) at baseline, 3, 6 and 12 months self-report questionnaire 4. Opioid use (mean daily MED) at 3, 6 and 12 months. A self-reported pain medicines use questionnaire (developed for this research programme, tested in the feasibility study and refined in light of the findings) will collect data on opioid use (prescribed and non-prescribed) during the previous week (7 days). Incomplete data on prescribed medicines will be obtained, where possible, by telephone or from the electronic prescribing record. Mean daily MED will be calculated using published conversion factors. 5. Non-opioid pain-related medicines use, assessed from the self-reported pain medicines use questionnaire at baseline, 3, 6 and 12 months. Incomplete data on prescribed medicines will be obtained, where possible, by telephone or from the electronic prescribing record. 6. Presence and severity of opioid-related side-effects, assessed from a self-reported side effects checklist (developed for this research programme from existing measures and tested in a feasibility study) at baseline, 3, 6 and 12 months self-report questionnaire. 7. Depressive symptoms assessed using the Patient Health Questionnaire Depression Scale (PHQ-8) at baseline, 3, 6 and 12 months self-report 8. Anxiety symptoms assessed using the Generalised Anxiety Assessment (GAD-7) at baseline, 3, 6 and 12 months self-report 9. Confidence to cope with pain (pain self-efficacy) using the Pain Self-Eff | — |
Countries
United Kingdom
Outcome results
None listed