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

NCT06620133 | Recruiting

• 1 other identifier: CAPACITY trial
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain (Non-specific, Uncomplicated)

Keywords

pain education; patient-led goal setting; chronic low back pain

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale

  Week 26 post-randomisation

• Disability

  Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability

  Week 26 post-randomisation

Secondary Outcomes (17)

• 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

Study Arms (2)

Pain education and patient-led goal setting

EXPERIMENTAL

Pain education and patient-led goal setting

Other: Pain education and patient-led goal setting

Written advice

EXPERIMENTAL

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

Other: Guideline-based written advice

Interventions

Pain education and patient-led goal setting OTHER

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 healthcare practitioner will take an initial history of the participants physical activity behaviours and problems related to their back pain. The participant will prioritise their problems according to impact in their life. Strategies will then be discussed, and the participant will, in collaboration with the healthcare practitioner, set goals and strategies to work on independently between sessions.

Pain education and patient-led goal setting

Guideline-based written advice OTHER

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.

Written advice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuroscience Research Australia: lead

Study Sites (1)

Neuroscience Research Australia

Sydney, New South Wales, Australia

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Study Officials

• Matthew D Jones

  UNSW Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew D Jones

CONTACT

+61 9348 0032; capacity@neura.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: October 1, 2024
• Study Start: June 26, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 9, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be made available after the publication of study reports. There is no end date for the availability of study data

Locations

AU (1)