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Reconceptualising patient-reported outcome measures for back pain

Reconceptualising Patient-Reported Outcome Measures (RPROMs): a cluster randomised controlled trial and process evaluation on PROMs in specialist musculoskeletal care for back pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82172279
Enrollment
300
Registered
2018-03-22
Start date
2018-01-31
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back pain management by chiropractors in private settings Musculoskeletal Diseases

Interventions

The cRCT aims to evaluate the outcome of the intervention (study objective A). The process evaluation aims to understand the processes by which an intervention functions, by examining its implementati

Sponsors

University of Southampton
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Chiropractors: 1. Be registered with the General Chiropractic Council 2. Speak and read English fluently, as the PROM used within this study has not been translated into other languages and independently assessed for validity and reliability 3. Be able to comply with all study procedures Patients: 1. Be at least 16 years old. Due to the biological and psychological differences between children, adolescents and adults, children and adolescents have been excluded from the scope of this project 2. Speak and read English fluently. As with the chiropractors, the inclusion criteria of speaking and reading English fluently has been set so study participants may coherently understand the questions in the PROMs used in the study 3. Be a private patient presenting to the musculoskeletal clinic 4. Present to the clinic with self-reported back pain

Exclusion criteria

Exclusion criteria: Chiropractors: 1. Chiropractors who are not registered with the General Chiropractic Council 2. Chiropractors who cannot speak and read English fluently Patients: 1. Patients who are under 16 years old 2. Patients who cannot speak and read English fluently 3. NHS patients presenting to the musculoskeletal clinic 4. Patients who do not have self-reported back pain

Design outcomes

Primary

MeasureTime frame
Back pain (physical functioning and disability) measured with the Roland-Morris Questionnaire at baseline and 90 days

Secondary

MeasureTime frame
Quantitative secondary outcome measures measured at 90 days: 1. Health-related quality of life (HRQoL), measured using the EQ-5D thermometer 2. Pain-related fear, measured using the fear subscale of the pain anxiety symptoms scale (PASS-20) 3. Pain catastrophising, measured using the catastrophising subscale of the coping strategies questionnaire (CSQ-CAT) 4. Fear-avoidance behaviours, measured using the fear-avoidance beliefs questionnaire physical activity subscale (FABPA) 5. Self-efficacy for self-management, measured using the self-efficacy beliefs in patients with chronic pain subscale - self-efficacy for pain management (PSE) 6. Self-management behaviours, measured using the maintenance subscale of the pain stages of change questionnaire (PSOCQ) 7. Treatment perceptions, measured using four-item low back pain treatment beliefs questionnaire 8. Patient-centered communication, measured using patient perception of patient centeredness questionnaire 9. Therapeutic alliance, measured using working alliance inventory - short-revised (WAI_SR) 10. Patient satisfaction, measured using a one-item question: “Over the course of chiropractic treatment for your low back pain how would you rate your overall care?”, scored on a five-point scale from ‘very dissatisfied’ to ‘very satisfied’ 11. Intervention fidelity, measured using a one-item question: “Did you and your chiropractor discuss the questionnaires that you filled in before, during and after your treatment?”, scored on a seven point scale from ‘never’ to ‘always' Nested qualitative study: 1. Audio recordings - one participant per cluster will be randomly sampled to have their treatment sessions audio recorded. The audio recordings will allow researchers to explore and understand the behaviour and activities of p

Countries

England, United Kingdom

Contacts

Public ContactMichelle Holmes

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026