SPIRAL study: Self-managing Pain In aRthritis and ArthropLasty
| ISRCTN | ISRCTN52305381 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52305381 |
| Protocol serial number | 11270 |
| Sponsor | North Bristol NHS Trust (UK) |
| Funder | NIHR (UK) - Programme Grants for Applied Research |
- Submission date
- 28/06/2013
- Registration date
- 28/06/2013
- Last edited
- 03/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Vikki Wylde
Scientific
Scientific
Bristol Implant Research Centre
Southmead Hospital
Southmead Road Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
| v.wylde@bristol.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Feasibility randomised controlled trial; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Scientific title | A feasibility randomised controlled trial of a pain self-management group for patients undergoing total hip replacement |
| Study acronym | SPIRAL |
| Study objectives | This pilot randomised controlled trial will involve delivering a pain self-management course to patients undergoing total hip replacement (THR). The course will be delivered by Arthritis Care and will consist of two workshops while patients are on the waiting list for a THR and one workshop at 6-9 weeks post-operative. Eighty patients will be recruited into the study and randomised to the control or intervention arm and then followed-up by postal questionnaire for 6-months after surgery. The study will assess the feasibility of a full-scale randomised controlled trial in terms of recruitment rates, reasons for non-participation, attendance at the course, the suitability of outcome measures and assessment timings. More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=11270 |
| Ethics approval(s) | South West 4 NRES Committee, ref: 11/SW/0056; First MREC approval date 03/06/2011 |
| Health condition(s) or problem(s) studied | Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Osteoarthritis, hip replacement |
| Intervention | Pain self-management course, The Challenging Pain course is a pain self-management course run by Arthritis Care. The course will be delivered to participants by lay trainers who have experience of living with chronic pain. The emphasis of the course is on pain management and introduces participants to a variety of cognitive pain management techniques, with the aim of providing coping skills to enable patients to manage their pain and its impact more effectively. Follow Up Length: 6 months Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure(s) |
Feasibility of a full scale randomised controlled trial; Timepoint(s): From recruitment to 6-months after surgery |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 27/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Listed for a primary total hip replacement because of osteoarthritis 2. Target Gender: Male & Female ; Lower Age Limit 18 years |
| Key exclusion criteria | Listed for revision surgery Inability or unwillingness to provide informed consent |
| Date of first enrolment | 20/06/2011 |
| Date of final enrolment | 27/06/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Bristol Implant Research Centre
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/05/2014 | Yes | No |
