Supervised Walking In comparison to Fitness Training for back pai

Not Applicable

Completed

• Conditions: Chronic low back pain; Musculoskeletal Diseases; Dorsalgia

• Registration Number: ISRCTN17592092
• Lead Sponsor: Health Research Board (HRB) (Ireland)

Brief Summary

1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19573247 2. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25599309 (added 21/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-08
• Study Completion: 2010-10-01
• Last Update Posted: 9 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

1. Patients with chronic (greater than or equal to three months) or recurrent (greater than or equal to three episodes in previous 12 months) LBP of mechanical origin with/without radiation to the lower limb
2. Males/females between 18 - 65 years
3. No spinal surgery within the previous 12 months
4. Patients deemed suitable by their General Practitioner (GP)/hospital consultant to carry out an exercise programme
5. Patients willing to attend for an 8-week treatment programme of exercise classes
6. Access to a telephone (for follow-up support)
7. Fluency in English (verbal and written)
8. Low levels of physical activity measured by the International Physical Activity Questionnaire (IPAQ) (less than 600 MET-minutes/week)

Exclusion Criteria

1. Currently or having received treatment for chronic low back pain (CLBP) within previous three months
2. Red flags indicating serious spinal pathology, e.g. cancer, cauda equina lesion
3. Radicular pain indicative of nerve root compression
4. Patients diagnosed with severe spinal stenosis, spondylolisthesis, fibromyalgia
5. History of systemic/inflammatory disease, e.g. rheumatoid arthritis
6. Patients with any confounding conditions such as a neurological disorder or currently receiving treatment for cancer
7. Patients with acute (less than six weeks) or subacute LBP (6 - 12 weeks), provided that they have experienced less than three LBP episodes during previous 12 months
8. Unstable angina/uncontrolled cardiac dysrhythmias/severe aortic stenosis/acute systemic infection accompanied by fever
9. Medico-legal issues

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index, measured at 3, 6 and 12 months by postal follow-up.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Pain using a Numerical Rating Scale<br> 2. Health-related quality of life measured by the EuroQol questionnaire<br> 3. Psychosocial beliefs using the Fear Avoidance Beliefs Questionnaire and the Back Beliefs Questionnaire<br> 4. Number of days reported sick leave over the past year for those in paid employment only<br> 5. Physical activity levels using the International Physical Activity Questionnaire (IPAQ), an exercise diary and the activPalTM accelerometer<br> 6. Patient satisfaction will be assessed using Likert scales assessing satisfaction with outcome and satisfaction with care<br> 7. Self efficacy questionnaire<br><br> The outcomes will be measured at 3, 6 and 12 months by postal follow-up.<br>