The Effect of Pain Education and Patient-led Goal Setting Compared to Guideline-based Written Information on Pain and Disability in Adults With Chronic Low Back Pain: a Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Pain education and patient-led goal setting
- Conditions
- Not specified
- Sponsor
- Neuroscience Research Australia
- Enrollment
- 392
- Locations
- 1
- Primary Endpoint
- Pain intensity
- Status
- Recruiting
- Last Updated
- 23 days ago
Overview
Brief Summary
The goal of this clinical trial is to investigate the effectiveness of two treatments for adults with chronic low back pain. The main question this study seeks to answer is "In adults with chronic low back pain, what is the effectiveness of pain education and patient-led goal setting compared to guideline-based written advice on reducing pain intensity and disability?".
A total of 392 participants will be randomised into two groups: 1) pain education and patient-led goal setting or 2) guideline-based written advice. Participants randomised to the pain education and patient-led goal setting group will receive 5 sessions of 45-60 min each over 8 weeks delivered online via telehealth. Participants randomised to written advice group will receive information developed for people with chronic low back pain. Outcomes will be assessed at baseline and week 8, 26 and 52.
Investigators
Matthew Jones
Principal Investigator
Neuroscience Research Australia
Eligibility Criteria
Inclusion Criteria
- •Low back pain of at least 3 months duration
- •physically inactive (less than or equal to 150min/week moderate intensity physical activity; 75 min/week vigorous activity, or some combination of the two)
- •no known contraindication(s) to performing physical activity
- •English language proficiency
- •access to internet
Exclusion Criteria
- •physically active (more than 150min/week moderate intensity physical activity, 75 min/week vigorous activity, or some combination of the two)
- •known contraindication(s) to performing physical activity
- •known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome/widespread neurological disorder)
- •scheduled for major surgery during the treatment or follow-up period
Arms & Interventions
Pain education and patient-led goal setting
Pain education and patient-led goal setting
Intervention: Pain education and patient-led goal setting
Written advice
Guideline-based written advice developed for people with chronic low back pain (e.g. https://pubmed.ncbi.nlm.nih.gov/34283182/)
Intervention: Guideline-based written advice
Outcomes
Primary Outcomes
Pain intensity
Time Frame: Week 26 post-randomisation
Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale
Disability
Time Frame: Week 26 post-randomisation
Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability
Secondary Outcomes
- Pain intensity(Weeks 8 and 52 post-randomisation)
- Disability(Weeks 8 and 52 post-randomisation)
- Pain self-efficacy(Weeks 8, 26 and 52 post-randomisation)
- Back beliefs(Weeks 8, 26 and 52 post-randomisation)
- Kinesiophobia(Weeks 8, 26 and 52 post-randomisation)
- EuroQol 5-Dimension 5-Level (EQ-5D-5L)(Weeks 8, 26 and 52 post-randomisation)
- Daily step count(Week 8 post-randomisation)
- Light intensity physical activity(Week 8 post-randomisation)
- Moderate-vigorous intensity physical activity(Week 8 post-randomisation)
- Sedentary time(Week 8 post-randomisation)
- Subjective physical activity levels(Weeks 8, 26 and 52 post-randomisation)
- Blood pressure(Week 8 post-randomisation)
- Adverse events(From randomisation to Week 8 post-randomisation)
- Adherence to treatment(From randomisation to Week 8 post-randomisation)
- Lifestyle risk factors(Weeks 8, 26 and 52 post-randomisation)
- Total healthcare costs(Weeks 8, 26 and 52 post-randomisation)
- Goal attainment (goal setting arm only)(Weeks 8, 26 and 52 post-randomisation)