Chronic low back pain Musculoskeletal Diseases Dorsalgia
Conditions
Interventions
1. Supervised exercise class (SEC):
Within one week of randomisation, participants will commence the SEC. This class will follow a group-based format based on the 'Back to Fitness' programme used in
recording of the patient's exercise capabilities and perceived barriers to recovery and the individual's treatment expectations. Participants will then attend the Physiotherapy Department of Beaumont
recording of the patient's exercise capabilities and perceived barriers to recovery and the
Sponsors
Health Research Board (HRB) (Ireland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males/females aged between 18 - 70 years 2. Patients with chronic (greater than or equal to 3 months) or recurrent (greater than or equal to three episodes in the previous 12 months) low back pain (LBP) of mechanical origin with/without radiation to the lower limb 3. No spinal surgery within the previous 12 months 4. Patients deemed suitable by their GP/hospital consultant to carry out an exercise programme 5. Patients willing to attend for an 8-week treatment programme of exercise classes 6. Fluency in English (verbal and written) 7. Access to a telephone (for follow-up support)
Exclusion criteria
Exclusion criteria: 1. Clinically diagnosed primary sleep disorder, e.g., sleep apnoea, insomnia 2. Currently on sleeping medication 3. Currently or having received treatment for CLBP within previous 3 months 4. Patients with minimum disability on the Oswestry Disability Index (less than 10) 5. Red flags indicating serious spinal pathology, e.g., cancer, cauda equina lesion 6. Radicular pain indicative of nerve root compression 7. Patients diagnosed with severe spinal stenosis, spondylolisthesis, fibromyalgia 8. History of systemic/inflammatory disease, e.g., rheumatoid arthritis 9. Patients with any confounding conditions such as a neurological disorder or currently receiving treatment for cancer 10. Patients with acute (less than 6 weeks) or subacute LBP (6 - 12 weeks), provided that they have experienced less than three LBP episodes during previous 12 months 11. Unstable angina/uncontrolled cardiac dysrhythmias/severe aortic stenosis/acute systemic infection accompanied by fever 12. Medico-legal issues 13. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Self-reported sleep quality using the Pittsburgh Sleep Quality Index, Insomnia Severity Index, and the Pittsburgh Sleep Diary 2. Objective sleep quality using the Actiwatch (Model AW4, CamNTech, Cambridge, UK) on all patients and the Sleep Minder (BiancaMed Ltd, Dublin, Ireland) on a sample of the patients recruited on two separate occasions each lasting seven nights: 2.1. At baseline, and 2.2. Three months after initial randomisation 3. Functional disability due to LBP measured by the Oswestry Disability Index (ODI) 4. Pain using Numerical Rating Scales for current and average pain for both back and leg pain 5. Health-related quality of life measured by the 36-item Short-Form, Version 2 questionnaire 6. Psycho-social beliefs using the Fear Avoidance Beliefs Questionnaire and the Anxiety and Depression using the Hospital Anxiety and Depression Scale 7. Employment status and number of days reported sick leave over the past year for those in paid employment only 8. Self-report physical activity levels using the International Physical Activity Questionnaire (IPAQ) 9. Exercise self efficacy questionnaire 10. Patient satisfaction will be assessed using Likert scales assessing satisfaction with outcome and satisfaction with care at 3 months only All outcomes are measured at baseline, 3 and 6 months, apart from objective sleep measures of actiwatch and sleep minder (baseline and 3 months) and patient satisfaction (3 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Ireland
Outcome results
None listed