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

Not Applicable

Recruiting

• Conditions: Chronic Low Back Pain (Non-specific, Uncomplicated)
• Interventions: Other: Supervised group exercise; Other: Pain education and patient-led goal setting

• Registration Number: NCT06620133
• Lead Sponsor: Neuroscience Research Australia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-22
• Study First Submitted QC: 2024-09-26
• Study First Posted: 2024-10-01
• Status Verified: 2025-06
• Study Start: 2025-06-09
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-17
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 392

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised group exercise	Supervised group exercise	Supervised group exercise
Pain education and patient-led goal setting	Pain education and patient-led goal setting	Pain education and patient-led goal setting

Primary Outcome Measures

Name	Time	Method
Pain intensity	Week 26 post-randomisation	Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale
Disability	Week 26 post-randomisation	Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability

Secondary Outcome Measures

Name	Time	Method
Pain intensity	Weeks 8 and 52 post-randomisation	Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale
Disability	Weeks 8 and 52 post-randomisation	Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability
Pain self-efficacy	Weeks 8, 26 and 52 post-randomisation	Pain self-efficacy assessed using the Pain Self-Efficacy Questionnaire (PSEQ); scale range 0-60; higher scores indicate greater pain self-efficacy
Back beliefs	Weeks 8, 26 and 52 post-randomisation	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
Kinesiophobia	Weeks 8, 26 and 52 post-randomisation	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)
EuroQol 5-Dimension 5-Level (EQ-5D-5L)	Weeks 8, 26 and 52 post-randomisation	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).
Daily step count	Week 8 post-randomisation	Average daily step count over the past 7 days assessed using accelerometry.
Light intensity physical activity	Week 8 post-randomisation	Light intensity physical activity (min/day) over the past 7 days assessed using accelerometry
Moderate-vigorous intensity physical activity	Week 8 post-randomisation	Moderate-vigorous intensity physical activity (min/day) over the past 7 days assessed using accelerometry
Sedentary time	Week 8 post-randomisation	Sedentary time (min/day) over the past 7 days assessed using accelerometry
Subjective physical activity levels	Weeks 8, 26 and 52 post-randomisation	Self-reported physical activity over the previous 7 days assessed using the short-form of the International Physical Activity Questionnaire (IPAQ)
Blood pressure	Week 8 post-randomisation	Blood pressure at rest assessed via an automated sphygmomanometer
Adverse events	From randomisation to Week 8 post-randomisation	Adverse events assessed via self-report
Adherence to treatment	From randomisation to Week 8 post-randomisation	Adherence to treatment assessed via session attendance and self-report (diary)
Lifestyle risk factors	Weeks 8, 26 and 52 post-randomisation	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)
Total healthcare costs	Weeks 8, 26 and 52 post-randomisation	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.
Goal attainment (goal setting arm only)	Weeks 8, 26 and 52 post-randomisation	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.

Trial Locations

Locations (1)

Neuroscience Research Australia; 🇦🇺 Sydney, New South Wales, Australia