A randomised controlled trial to determine the effectiveness of a healthy lifestyle program for patients with chronic low back pain who are overweight or obese.
- Conditions
- Overweight and ObesityLow Back PainMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12617001288314
- Lead Sponsor
- Hunter New England Population Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 346
Eligible patients will be: 18 years of age or older with chronic low back pain, defined as pain between the 12th rib and buttock crease, with or without leg pain of more than 3 months duration; Pain greater or equal to 3 on the Numerical Rating Scale or Moderate interference with daily activities of living (adapted from question in SF36).
Patients will be excluded if they: are unable to use a telephone; do not live independently (i.e. require care for activities of daily living); are currently undertaking weight management or smoking cessation programs; have planned surgery in the next 6 months; are pregnant or planning pregnancy at the time of enrolment, or have a comorbidity that precludes understanding or participation in study procedures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be disability measured on the Roland Morris Disability Questionnaire - a 24 item low back pain specific survey, which has been validated and is a recommended core outcome for trials in low back pain. [Baseline, Week 6, 12, 26 and 52 (Primary endpoint is 6 months (26 weeks) post-randomisation)]
- Secondary Outcome Measures
Name Time Method