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NCT Number: NCT06620133

Pain Education and Patient-led Goal Setting 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuroscience Research Australia

Sydney, New South Wales, Australia

Location status: Recruiting

Location contact

Imtiaz Desai

CONTACT

[email protected]

+61 404 272 990

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain intensity

    Time frame: Week 26 post-randomisation

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

  2. Disability

    Time frame: 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 outcomes

  1. Pain intensity

    Time frame: Weeks 8 and 52 post-randomisation

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

  2. Disability

    Time frame: 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

  3. Pain self-efficacy

    Time frame: 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

  4. Back beliefs

    Time frame: 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

  5. Kinesiophobia

    Time frame: 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)

  6. EuroQol 5-Dimension 5-Level (EQ-5D-5L)

    Time frame: 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).

  7. Daily step count

    Time frame: Week 8 post-randomisation

    Average daily step count over the past 7 days assessed using accelerometry.

  8. Light intensity physical activity

    Time frame: Week 8 post-randomisation

    Light intensity physical activity (min/day) over the past 7 days assessed using accelerometry

  9. Moderate-vigorous intensity physical activity

    Time frame: Week 8 post-randomisation

    Moderate-vigorous intensity physical activity (min/day) over the past 7 days assessed using accelerometry

  10. Sedentary time

    Time frame: Week 8 post-randomisation

    Sedentary time (min/day) over the past 7 days assessed using accelerometry

  11. Subjective physical activity levels

    Time frame: 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)

  12. Lifestyle risk factors

    Time frame: 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)

  13. Blood pressure

    Time frame: Week 8 post-randomisation

    Blood pressure at rest assessed via an automated sphygmomanometer

  14. Adverse events

    Time frame: From randomisation to Week 8 post-randomisation

    Adverse events assessed via self-report

  15. Adherence to treatment

    Time frame: From randomisation to Week 8 post-randomisation

    Adherence to treatment assessed via session attendance and self-report (diary)

  16. Total healthcare costs

    Time frame: 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.

  17. Goal attainment (goal setting arm only)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew D Jones

CONTACT

[email protected]

+61 9348 0032

Sponsors and collaborators

Lead sponsor

Neuroscience Research Australia

Other

Registry information

Official study 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

Acronym: CAPACITY

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Oct 1, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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