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Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS)

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN49875385
Enrollment
144
Registered
2014-03-26
Start date
2014-03-31
Completion date
Unknown
Last updated
2020-10-05

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

Conditions

Osteoarthritis of the lumbar spine, hip and/or knee joints Chronic non-specific low back pain Musculoskeletal Diseases Osteoarthritis

Interventions

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 discr

Sponsors

Health Research Board (Ireland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. Participant?s satisfaction with outcome and care received 7. Participant?s 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. Participant?s satisfaction with outcome and care received 7. Participant?s global impression of change 8. Hospital Anxiety and Depression Scale

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026