Clinical trial NCT06620133: Pain Education and Patient-led Goal Setting in Adults With Chronic Low Back Pain: a Randomised Controlled Trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain (Non-specific, Uncomplicated)
Keywords: pain education
patient-led goal setting
chronic low back pain
Lead sponsor: Neuroscience Research Australia
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain intensity
timeFrame: Week 26 post-randomisation
measure: Disability
timeFrame: Week 26 post-randomisation
Secondary outcomes:
measure: Pain intensity
timeFrame: Weeks 8 and 52 post-randomisation
measure: Disability
timeFrame: Weeks 8 and 52 post-randomisation
measure: Pain self-efficacy
timeFrame: Weeks 8, 26 and 52 post-randomisation
measure: Back beliefs
timeFrame: Weeks 8, 26 and 52 post-randomisation
measure: Kinesiophobia
timeFrame: Weeks 8, 26 and 52 post-randomisation
measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: Weeks 8, 26 and 52 post-randomisation
measure: Daily step count
timeFrame: Week 8 post-randomisation
measure: Light intensity physical activity
timeFrame: Week 8 post-randomisation
measure: Moderate-vigorous intensity physical activity
timeFrame: Week 8 post-randomisation
measure: Sedentary time
timeFrame: Week 8 post-randomisation
measure: Subjective physical activity levels
timeFrame: Weeks 8, 26 and 52 post-randomisation
measure: Lifestyle risk factors
timeFrame: Weeks 8, 26 and 52 post-randomisation
measure: Blood pressure
timeFrame: Week 8 post-randomisation
measure: Adverse events
timeFrame: From randomisation to Week 8 post-randomisation
measure: Adherence to treatment
timeFrame: From randomisation to Week 8 post-randomisation
measure: Total healthcare costs
timeFrame: Weeks 8, 26 and 52 post-randomisation
measure: Goal attainment (goal setting arm only)
timeFrame: Weeks 8, 26 and 52 post-randomisation
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Neuroscience Research Australia
state: New South Wales
Study officials:
affiliation: UNSW Sydney
name: Matthew D Jones
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.