SPIRAL study: Self-managing Pain In aRthritis and ArthropLasty
| ISRCTN | ISRCTN52305381 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52305381 |
| Secondary identifying numbers | 11270 |
- 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
| Study design | Feasibility randomised controlled trial; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Feasibility of a full scale randomised controlled trial; Timepoint(s): From recruitment to 6-months after surgery |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 20/06/2011 |
| Completion date | 27/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 80; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
Bristol Implant Research Centre
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
North Bristol NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Trust Headquarters
Beckspool Road
Frenchay
Bristol
B16 1JE
England
United Kingdom
| Website | http://www.nbt.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
NIHR (UK) - Programme Grants for Applied Research
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
