Pain Education and Patient-led Goal Setting in Adults With Chronic Low Back Pain: a Randomised Controlled Trial (CAPACITY)

Neuroscience Research Australia

Status: Enrolling

Conditions: Chronic Low Back Pain (Non-specific, Uncomplicated)

Treatments: Other: Guideline-based written advice; Other: Pain education and patient-led goal setting

Study type: Interventional

Funder types: Other

Identifiers

NCT06620133

CAPACITY trial

Details and patient eligibility

About

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.

Enrollment: 392 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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392 participants in 2 patient groups

Pain education and patient-led goal setting

Experimental group

Description:

Pain education and patient-led goal setting

Treatment:

Other: Pain education and patient-led goal setting

Written advice

Experimental group

Description:

Guideline-based written advice developed for people with chronic low back pain (e.g. https://pubmed.ncbi.nlm.nih.gov/34283182/)

Treatment:

Other: Guideline-based written advice