Pain Education and Patient-led Goal Setting in Adults With Chronic Low Back Pain: a Randomised Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pain education and patient-led goal setting, Guideline-based written advice.
- Who it may be relevant to
- Registry conditions: Chronic Low Back Pain (Non-specific, Uncomplicated). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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.
Interventions
- Other Pain education and patient-led goal setting
8 week program delivered via five, up to 1-hour telehealth sessions. The sessions will be scheduled at approximately fortnightly intervals. Participants will also be prescribed approximately 30 minutes of online activities with each session. Pain education will be based on Explain Pain and the curriculum will have specified learning objectives adapted for each individual participant. Participants will access the online education curriculum through Pathwright. For patient-led goal setting, the he - Other Guideline-based written advice
Participants will receive guideline-based written information for the management of chronic low back pain. This will include information about the prognosis of low back pain and treatment options to consider.
Primary outcome measures
- Pain intensity [Time frame: Week 26 post-randomisation]
- Disability [Time frame: Week 26 post-randomisation]
Secondary outcome measures (12)
- Pain intensity [Time frame: Weeks 8 and 52 post-randomisation]
- Disability [Time frame: Weeks 8 and 52 post-randomisation]
- Pain self-efficacy [Time frame: Weeks 8, 26 and 52 post-randomisation]
- Back beliefs [Time frame: Weeks 8, 26 and 52 post-randomisation]
- Kinesiophobia [Time frame: Weeks 8, 26 and 52 post-randomisation]
- EuroQol 5-Dimension 5-Level (EQ-5D-5L) [Time frame: Weeks 8, 26 and 52 post-randomisation]
- Daily step count [Time frame: Week 8 post-randomisation]
- Light intensity physical activity [Time frame: Week 8 post-randomisation]
- Moderate-vigorous intensity physical activity [Time frame: Week 8 post-randomisation]
- Sedentary time [Time frame: Week 8 post-randomisation]
- Subjective physical activity levels [Time frame: Weeks 8, 26 and 52 post-randomisation]
- Lifestyle risk factors [Time frame: Weeks 8, 26 and 52 post-randomisation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Neuroscience Research Australia — Sydney
Publications
- Gardner T, Refshauge K, McAuley J, Hubscher M, Goodall S, Smith L. Combined education and patient-led goal setting intervention reduced chronic low back pain disability and intensity at 12 months: a randomised controlled trial. Br J Sports Med. 2019 Nov;53(22):1424-1431. doi: 10.1136/bjsports-2018-100080. Epub 2019 Feb 26. PMID 30808666
Identifiers
NCT: NCT06620133 · CAPACITY trial