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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low Back Pain (Non-specific, Uncomplicated)
• Intervention / Treatment: Other: Pain education and patient-led goal setting; Other: Guideline-based written advice

• Study Type: Interventional
• Enrollment (Estimated): 392
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew D Jones; Phone Number: +61 9348 0032; Email: capacity@neura.edu.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • Recruiting
      • Neuroscience Research Australia
      • Contact: Imtiaz Desai; Phone Number: +61 404 272 990; Email: capacity@neura.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain education and patient-led goal setting	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 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.
Experimental: Written advice; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale	Weeks 8 and 52 post-randomisation
Disability	Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability	Weeks 8 and 52 post-randomisation
Back beliefs	Back beliefs assessed using the Back Beliefs Questionnaire (BBQ); scale range 9-45, lower scores indicate more pessimistic beliefs about the consequences of low back pain	Weeks 8, 26 and 52 post-randomisation
EuroQol 5-Dimension 5-Level (EQ-5D-5L)	Health-Related Quality of Life assessed using the EQ-5D-5L dimensions scale range, 1-5; higher scores indicate better quality of life) and health thermometer (range, 0-100; higher scores indicate better quality of life).	Weeks 8, 26 and 52 post-randomisation
Daily step count	Average daily step count over the past 7 days assessed using accelerometry.	Week 8 post-randomisation
Light intensity physical activity	Light intensity physical activity (min/day) over the past 7 days assessed using accelerometry	Week 8 post-randomisation
Moderate-vigorous intensity physical activity	Moderate-vigorous intensity physical activity (min/day) over the past 7 days assessed using accelerometry	Week 8 post-randomisation
Sedentary time	Sedentary time (min/day) over the past 7 days assessed using accelerometry	Week 8 post-randomisation
Subjective physical activity levels	Self-reported physical activity over the previous 7 days assessed using the short-form of the International Physical Activity Questionnaire (IPAQ)	Weeks 8, 26 and 52 post-randomisation
Lifestyle risk factors	Diet (do you eat less than two serves of fruit per day? (yes/no); do you eat less than fives serves of vegetables per day? (yes/no)). Alcohol intake (On average, how much alcohol do you drink each week? (I rarely/never drink alcohol; Less than 14 standard drinks; Between 14 and 21 standard drinks; More than 21 standard drinks)	Weeks 8, 26 and 52 post-randomisation
Blood pressure	Blood pressure at rest assessed via an automated sphygmomanometer	Week 8 post-randomisation
Adverse events	Adverse events assessed via self-report	From randomisation to Week 8 post-randomisation
Adherence to treatment	Adherence to treatment assessed via session attendance and self-report (diary)	From randomisation to Week 8 post-randomisation
Total healthcare costs	Total health-care costs will be estimated as the trial intervention costs and outside trial health-care resource use attributable to chronic low back pain from the Medicare Benefits Scheme and Pharmaceutical Benefits Scheme. Quality-adjusted life-years (QALYs) from the EQ-5D-5L using the Australian utility weights will also be used in the trial-based cost-utility analysis.	Weeks 8, 26 and 52 post-randomisation
Goal attainment (goal setting arm only)	Goal attainment assessed using the goal attainment scale. Each goal is rated on a 5-point scale: +2 = much more than expected, +1 = somewhat more than expected, 0 = Patient achieves the expected level, -1 = somewhat less than expected, -2 = much less than expected.	Weeks 8, 26 and 52 post-randomisation
Pain self-efficacy	Pain self-efficacy assessed using the Pain Self-Efficacy Questionnaire (PSEQ); scale range 0-60; higher scores indicate greater pain self-efficacy	Weeks 8, 26 and 52 post-randomisation
Kinesiophobia	Fear of movement (re)injury assessed by the short-form of the Tampa Scale of Kinesiophobia; scale range 4-16 (higher scores indicate greater kinesiophobia)	Weeks 8, 26 and 52 post-randomisation

Collaborators and Investigators

• Sponsor: Neuroscience Research Australia
• Investigators: Principal Investigator: Matthew D Jones, UNSW Sydney

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: September 22, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: chronic low back pain; pain education; patient-led goal setting
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CAPACITY trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified individual participant data will be made to interested researchers only upon reasonable request and once the proposed research project has received separate ethics approval from a Human Research Ethics Committee.

Request to the data custodian, the Principal Investigator (matthew.jones@unsw.edu.au)

• IPD Sharing Time Frame: Data will be made available after the publication of study reports. There is no end date for the availability of study data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No