Adult consulters in primary care with back, neck, knee, shoulder or multisite pain Signs and Symptoms
Conditions
Interventions
Current intervention as of 15/10/2019:
Approximately 24 GP practices in the UK will take part in the trial. 8 practices are recruited to a pilot phase before recruiting the remaining practices to the
Sponsors
Arthritis Research UK Primary Care Centre, Keele University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 31/08/2017: 1. Aged 18 years and over 2. Registered with a participating GP practice at the time of the specified study period 3. Read-coded relevant musculoskeletal consultation within the specified study period (this may be the first, or a repeat consultation) 4. Provided consent for the research team to have information from their GP medical records 5. A completed study template in the GP consultation 6. Consent to monthly follow-up 7. GP confirmation that the index pain is in the back, neck, shoulder, knee or is multi-site pain 8. Completion of the initial postal questionnaire within 4 weeks of their initial mailing date Previous inclusion criteria: 1. Aged 18 years and over 2. Registered with a participating GP practice at the time of the specified study period 3. Read-coded relevant musculoskeletal consultation within the specified study period (termed the “index consultation”; this may be the first, or a repeat consultation) 4. Provided consent for the research team to have information from their GP medical records 5. A completed study template in the GP consultation 6. Consent to monthly follow-up 7. GP confirmation that the index pain is in the back, neck, shoulder, knee or is multi-site pain 8. Completion of the initial postal questionnaire within 4 weeks of their initial mailing date
Exclusion criteria
Exclusion criteria: 1. Indications of serious ‘red flag’ pathology – for example, recent trauma with significant injury; acute, red, hot swollen joint; suspected fracture, joint infection or cancer; inflammatory arthropathy; crystal disease; spondyloarthropathy; polymyalgia rheumatic 2. Urgent care needs (e.g. Cauda Equina Syndrome) 3. Vulnerable patients, including any patients on the ‘Severe and enduring mental health register’ that GPs feel are not stable, or those who have a diagnosis of dementia, or those with a terminal illness, or those who have experienced recent trauma or bereavement 4. Those unable to communicate in English (both in reading and speaking)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity measured monthly over the study time period (0-6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline and 6 month follow-up secondary outcomes include: 1. Site-specific physical functional measures: 1.1. The Roland-Morris Disability Questionnaire (RMDQ) for patients with back pain 1.2. The Neck Disability Index (NDI), the Shoulder pain and disability index (SPADI) 1.3. The Knee Injury and Osteoarthritis Outcome Score Physical Function Short-form (KOOS-PS) 1.4. Physical function for patients with multi-site pain using the Short Form 12v2 Physical Component Scale 2. Other individual patient outcomes of interest include: 2.1. Patients’ musculoskeletal risk status using the STarT MSK Tool 2.2. Symptom severity and impact from the musculoskeletal pain problem measured using the 14-item Musculoskeletal Health Questionnaire, which includes measures of pain interference with sleep, hobbies/leisure activities, work and daily routine, and quality of life with items for patients’ confidence to manage their pain (self-efficacy), mood, and understanding of how to deal with their condition 2.3. Fear avoidance behaviours will be measured using the 11-item Tampa Scale of Kinesiophobia 2.4. Patient perceived level of reassurance from their GP will be captured using the Holt and Pincus et al reassurance scale, which has four sub-scales: information gathering, relationship building, generic reassurance and cognitive reassurance 2.5. A further quality of life scale EQ-5D-5L will be used to calculate quality adjusted life years (QALYs) used in the health economic evaluation There will be single item questions to capture patient satisfaction with care received, whether they received written education material from their GP, physical activity level, and overall rating of change since their index GP visit. 3. To help describe the population recruited, additional baseline descriptors will capture: 3.1. health literacy using the Single Item Literacy Screener (SILS) 3.2. episode duration of musculoskeletal pain by asking time since last whole month free from this pain 3.3. Age 3. | — |
Countries
England, United Kingdom
Contacts
Public ContactJonathan Hill
Outcome results
None listed