Chronic Low Back Pain (Non-specific, Uncomplicated)CAPACITYNCT06620133
Pain Education and Patient-led Goal Setting in Adults With Chronic Low Back Pain: a Randomised Controlled Trial
A study testing Pain education and patient-led goal setting and Guideline-based written advice in people with Chronic Low Back Pain (Non-specific, Uncomplicated), run by Neuroscience Research Australia at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain (Non-specific, Uncomplicated)
- What is being tested?
- Pain education and patient-led goal setting and Guideline-based written advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Jun 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Neuroscience Research Australia
Sydney, New South Wales
Imtiaz Desai, +61 404 272 990, capacity@neura.edu.au
About this study
Official 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
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.
- Being tested
- Pain education and patient-led goal setting, Guideline-based written advice
- Keywords
- pain education, patient-led goal setting, chronic low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain education and patient-led goal settingOther
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 adviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain education and patient-led goal setting | Experimental | Pain education and patient-led goal setting Receives: 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/) Receives: Other: Guideline-based written advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale
Measured: 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
Measured: Week 26 post-randomisation
Secondary outcomes (17)
Pain intensity
Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale
Measured: 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
Measured: Weeks 8 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
Measured: Weeks 8, 26 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
Measured: 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)
Measured: 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).
Measured: Weeks 8, 26 and 52 post-randomisation
Daily step count
Average daily step count over the past 7 days assessed using accelerometry.
Measured: Week 8 post-randomisation
Light intensity physical activity
Light intensity physical activity (min/day) over the past 7 days assessed using accelerometry
Measured: Week 8 post-randomisation
Moderate-vigorous intensity physical activity
Moderate-vigorous intensity physical activity (min/day) over the past 7 days assessed using accelerometry
Measured: Week 8 post-randomisation
Sedentary time
Sedentary time (min/day) over the past 7 days assessed using accelerometry
Measured: 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)
Measured: 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)
Measured: Weeks 8, 26 and 52 post-randomisation
Blood pressure
Blood pressure at rest assessed via an automated sphygmomanometer
Measured: Week 8 post-randomisation
Adverse events
Adverse events assessed via self-report
Measured: From randomisation to Week 8 post-randomisation
Adherence to treatment
Adherence to treatment assessed via session attendance and self-report (diary)
Measured: 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.
Measured: 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.
Measured: Weeks 8, 26 and 52 post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start26 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (Non-specific, Uncomplicated)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuroscience Research Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Jones, Neuroscience Research Australia
- Investigators
- Matthew D Jones, Principal investigator, UNSW Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620133
- Sponsor's protocol ID
- CAPACITY trial
- Acronym
- CAPACITY
- Status last verified
- Jun 2025
- First submitted
- 22 Sep 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
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.
PubMed 30808666
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06620133
- Acronym / sponsor ID
- CAPACITY / CAPACITY trial
- Keywords
- pain education, patient-led goal setting, chronic low back pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Neuroscience Research AustraliaUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain education and patient-led goal setting | Experimental | Other: Pain education and patient-led goal settingPain education and patient-led goal setting |
| Written advice | Experimental | Other: Guideline-based written adviceGuideline-based written advice developed for people with chronic low back pain (e.g. https://pubmed.ncbi.nlm.nih.gov/34283182/) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain education and patient-led goal setting8 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. | Other | Pain education and patient-led goal setting |
| Guideline-based written adviceParticipants 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. | Other | Written advice |
Primary outcome
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
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
17 secondary outcomes
Pain intensity
Time frame: Weeks 8 and 52 post-randomisation
Disability
Time frame: Weeks 8 and 52 post-randomisation
Pain self-efficacy
Time frame: Weeks 8, 26 and 52 post-randomisation
Back beliefs
Time frame: Weeks 8, 26 and 52 post-randomisation
Kinesiophobia
Time frame: Weeks 8, 26 and 52 post-randomisation
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Weeks 8, 26 and 52 post-randomisation
Daily step count
Time frame: Week 8 post-randomisation
Light intensity physical activity
Time frame: Week 8 post-randomisation
Moderate-vigorous intensity physical activity
Time frame: Week 8 post-randomisation
Sedentary time
Time frame: Week 8 post-randomisation
Subjective physical activity levels
Time frame: Weeks 8, 26 and 52 post-randomisation
Lifestyle risk factors
Time frame: Weeks 8, 26 and 52 post-randomisation
Blood pressure
Time frame: Week 8 post-randomisation
Adverse events
Time frame: From randomisation to Week 8 post-randomisation
Adherence to treatment
Time frame: From randomisation to Week 8 post-randomisation
Total healthcare costs
Time frame: Weeks 8, 26 and 52 post-randomisation
Goal attainment (goal setting arm only)
Time frame: Weeks 8, 26 and 52 post-randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 30808666Gardner 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.
- Individual participant dataSharing planned: Yes. 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)
Related trials for Chronic Low Back Pain (Non-specific, Uncomplicated)
Not yet recruiting
Comparison of Abdominal Expansion and Abdominal Drawing-In Training With Manual and Verbal Cueing in Chronic Non-Specific Low Back Pain
Chronic Low Back Pain (Non-specific, Uncomplicated)
Recruiting
Immediate Effects of Manual and Verbal Cueing During Movement Control Training in Chronic Non-Specific Low Back Pain
Chronic Low Back Pain (Non-specific, Uncomplicated)
Enrolling by invitation
Auricular Acupressure for Chronic Low Back Pain in Postmenopausal Women
Chronic Low Back Pain (Non-specific, Uncomplicated)
Not yet recruiting
Chronic Low Back Pain Comorbidities: Unravelling Impaired Glucose Metabolism
Chronic Low Back Pain (Non-specific, Uncomplicated), Chronic Low Back Pain (CLBP)
RecruitingEarly Phase 1
Evaluation of the Effectiveness and Safety of Mesotherapy in the Treatment of Chronic Low Back Pain Syndrome
Chronic Low Back Pain (Non-specific, Uncomplicated)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew D Jones principal investigator
UNSW Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain education and patient-led goal setting and Guideline-based written advice in people with Chronic Low Back Pain (Non-specific, Uncomplicated), run by Neuroscience Research Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew D Jones (+61 9348 0032, capacity@neura.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Week 26 post-randomisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06620133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.