Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS)
| ISRCTN | ISRCTN49875385 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49875385 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/03/2014
- Registration date
- 26/03/2014
- Last edited
- 25/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Research from other countries has shown that group physiotherapy, including education and exercise, is as effective as individual physiotherapy for people with hip and knee pain and costs less for the health service. The establishment of group education and exercise classes for clients with chronic hip, knee and back pain that promote self-management is a priority for Health Service Executive (HSE) community physiotherapy services in Ireland. But we do not know how feasible this is. This study will examine the feasibility of providing group education and exercise classes for self-management compared to individual physiotherapy treatment for people with chronic hip, knee and/or low back pain in HSE Community Physiotherapy services in Counties Dublin, Wicklow and Kildare.
Who can participate?
Male or female patients, 45 years old and over, diagnosed with osteoarthritis of any of the joints of the lumbar spine, hip or knee and/or low back pain.
What does the study involve?
At the first appointment, a research physiotherapist will ask each study participant about their pain and how they manage it, how often they exercise, their quality of life and their use of health services. Study participants will be randomly allocated to one of two groups (either group or individual physiotherapy treatment) and they will then receive the most appropriate physiotherapy care and treatment advice for their condition and how to manage it. Each study participant will then be contacted by a Researcher 2 and 6 months after the first appointment and asked the same questions to see if they have changed after their treatment. This study will help to improve future physiotherapy services for people who have hip, knee or back pain.
What are the possible risks of participating?
There are no risks involved in participating in this research.
Where is the study run from?
Health Service Executive (HSE) Primary, Community and Continuing Care Physiotherapy services of Dublin, Kildare and Wicklow (Ireland).
When is the study starting and how long is it expected to run for?
March 2014 to December 2016 (duration 30 months). The study will be recruiting participants for 24 months.
Who is funding the study?
Health Research Board of Ireland
Who is the main contact?
Dr Deirdre Hurley-Osing
deirdre.hurleyosing@ucd.ie
Contact information
Scientific
School of Public Health, Physiotherapy and Population Science
Health Science Centre
University College Dublin
Belfield
Dublin
D4
Ireland
| Phone | +353 (0) 1 7166524 |
|---|---|
| deirdre.hurleyosing@ucd.ie |
Study information
| Study design | Single-blinded feasibility cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Development of an evidence-based, theory-driven group education and exercise intervention to promote self-management for people with osteoarthritis of the lumbar spine, hip or knee and/or chronic low back pain in primary care physiotherapy: a single-blinded feasibility cluster randomized controlled trial within the MRC Framework for Complex Interventions |
| Study acronym | SOLAS |
| Study objectives | 1. The feasibility of providing the group education and exercise intervention to promote self-management compared to individual physiotherapy for clients with osteoarthritis of the lumbar spine/hip/knee and/or chronic low back pain within HSE Community Physiotherapy Services in Dublin, Wicklow and Kildare will be established 2. The protocol and sample size for a fully powered randomised controlled trial will be established |
| Ethics approval(s) | University College Dublin Human Research Ethics Committee Sciences, 17/12/2013, LS-13-54-Currie-Hurley |
| Health condition(s) or problem(s) studied | Osteoarthritis of the lumbar spine, hip and/or knee joints Chronic non-specific low back pain |
| Intervention | 1. Group education and exercise class to promote self-management, once per week for 6 weeks 2. Individual usual physiotherapy treatment, number and frequency of treatments at the discretion of the treating physiotherapist Total duration of follow-up is 6 months |
| Intervention type | Other |
| Primary outcome measure | 1. Acceptability, demand, practicality, and adaptation of the intervention to clients - baseline, 2 and 6 months 2. Acceptability, demand, implementation, practicality, adaptation and integration of intervention to physiotherapists - baseline, 1 and 2 months 3. Feasibility of recruitment process - baseline 4. Feasibility of outcome measurement process - baseline, 1, 2 and 6 months |
| Secondary outcome measures | Current secondary outcome measures as of 02/10/2014: 1. Self-management behaviours 2. International Physical Activity Questionnaire 3. Physical Component Summary of the Medical Outcomes Study Short Form Health Survey SF-12 4. Average pain intensity over the last week (0-10 scale) 5. Disease-specific functional disability: low back pain (Roland Morris Disability Questionnaire), and/or Hip and Knee OA (WOMAC function Daily Living Hip and/or Knee Subscale) 6. Participants satisfaction with outcome and care received 7. Participants global impression of change 8. Hospital Anxiety and Depression Scale 9. Client Services Receipt Inventory 10. EuroQol Weighted Health Index EQ5D-5L 11. Average symptom bothersomeness over the last week (0-5 scale) 12. Pain Catastrophising Scale (PCS) 13. Tampa Scale of Kinesiophobia Avoidance Subscale 14. Pain Self-Efficacy Questionnaire 15. Exercise Behaviour Regulation Questionnaire 16. Perceived Competence for Self-Management Questionnaire 17. Treatment Motivation Questionnaire 18. Health Care Climate Questionnaire Measured at baseline, 2 and 6 months Previous secondary outcome measures: 1. Self-management behaviours 2. International Physical Activity Questionnaire 3. Physical Component Summary of the Medical Outcomes Study Short Form Health Survey SF-12 4. Average pain intensity over the last week (0-10 scale) 5. Patient-Specific Functional Scale 6. Participants satisfaction with outcome and care received 7. Participants global impression of change 8. Hospital Anxiety and Depression Scale 9. Client Services Receipt Inventory 10. EuroQol Weighted Health Index EQ5D-5L Measured at baseline, 2 and 6 months |
| Overall study start date | 31/03/2014 |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 144 |
| Total final enrolment | 120 |
| Key inclusion criteria | Current inclusion criteria as of 02/10/2014: 1. Age ≥ 30 years for people with non-specific low back pain of mechanical origin with or without radiation to the lower limb 2. NICE (2014) working diagnosis of osteoarthritis of any of the joints of the lumbar spine, hip or knee defined as: age 45 years old or over, and activity-related joint pain and either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes or 3. Non-specific low back pain of mechanical origin with or without radiation to the lower limb ≥3 months 4. English speaking and English literate 5. Access to a telephone for screening and assessment 6. Willing to attend 6-week group education and exercise class Previous inclusion criteria: 1. ≥ 45 years of age 2. NICE (2014) working diagnosis of osteoarthritis of any of the joints of the lumbar spine, hip or knee defined as: age 45 years old or over, and activity-related joint pain and either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes or 3. Non-specific low back pain of mechanical origin with or without radiation to the lower limb ≥3 months 4. English speaking and English literate 5. Access to a telephone for screening and assessment 6. Willing to attend 6-week group education and exercise class |
| Key exclusion criteria | 1. Suspected or confirmed serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome/widespread neurological disorder) 2. Nerve root compromise (2 of strength, reflex or sensation affected for same nerve root) 3. Lower limb arthroplasty 4. Past medical history 5. Spinal surgery or history of systemic/inflammatory disease 6. Current medical status 7. Scheduled for major surgery during treatment 8. Contraindications 9. Unstable angina/uncontrolled cardiac dysrhythmias/severe aortic stenosis/acute systemic infection accompanied by fever Other 10. No confounding conditions, such as a neurological disorder, intellectual disorder or unstable psychiatric condition. 11. Bladder or bowel incontinence 12. People who are assessed to be at high risk of falls 13. Physiotherapy in the preceding 6 months 14. Unable or unwilling to attend 15. Ongoing litigation related to the pain condition |
| Date of first enrolment | 31/03/2014 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- Ireland
Study participating centre
D4
Ireland
Sponsor information
Government
73 Lower Baggot Street
Dublin
D2
Ireland
| Website | http://www.hrb.ie |
|---|---|
"ROR" |
https://ror.org/003hb2249 |
Funders
Funder type
Government
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/01/2016 | Yes | No | |
| Results article | results | 23/09/2020 | 25/09/2020 | Yes | No |
Editorial Notes
25/09/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
25/01/2016: Publication reference added.
