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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06620133
Registration number
NCT06620133
Ethics application status
Date submitted
22/09/2024
Date registered
1/10/2024
Date last updated
17/06/2025
Titles & IDs
Public title
Pain Education and Patient-led Goal Setting in Adults With Chronic Low Back Pain: a Randomised Controlled Trial
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Scientific 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
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Secondary ID [1]
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CAPACITY trial
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Universal Trial Number (UTN)
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Trial acronym
CAPACITY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain (Non-specific, Uncomplicated)
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Pain education and patient-led goal setting
Other interventions - Guideline-based written advice
Experimental: Pain education and patient-led goal setting - Pain education and patient-led goal setting
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 interventions: 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.
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pain intensity
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Assessment method [1]
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Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale
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Timepoint [1]
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Week 26 post-randomisation
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Primary outcome [2]
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Disability
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Assessment method [2]
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Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability
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Timepoint [2]
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Week 26 post-randomisation
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Secondary outcome [1]
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Pain intensity
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Assessment method [1]
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Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale
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Timepoint [1]
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Weeks 8 and 52 post-randomisation
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Secondary outcome [2]
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Disability
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Assessment method [2]
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Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability
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Timepoint [2]
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Weeks 8 and 52 post-randomisation
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Secondary outcome [3]
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Pain self-efficacy
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Assessment method [3]
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Pain self-efficacy assessed using the Pain Self-Efficacy Questionnaire (PSEQ); scale range 0-60; higher scores indicate greater pain self-efficacy
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Timepoint [3]
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Weeks 8, 26 and 52 post-randomisation
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Secondary outcome [4]
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Back beliefs
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Assessment method [4]
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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
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Timepoint [4]
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Weeks 8, 26 and 52 post-randomisation
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Secondary outcome [5]
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Kinesiophobia
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Assessment method [5]
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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)
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Timepoint [5]
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Weeks 8, 26 and 52 post-randomisation
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Secondary outcome [6]
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EuroQol 5-Dimension 5-Level (EQ-5D-5L)
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Assessment method [6]
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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).
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Timepoint [6]
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Weeks 8, 26 and 52 post-randomisation
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Secondary outcome [7]
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Daily step count
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Assessment method [7]
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Average daily step count over the past 7 days assessed using accelerometry.
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Timepoint [7]
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Week 8 post-randomisation
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Secondary outcome [8]
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Light intensity physical activity
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Assessment method [8]
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Light intensity physical activity (min/day) over the past 7 days assessed using accelerometry
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Timepoint [8]
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Week 8 post-randomisation
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Secondary outcome [9]
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Moderate-vigorous intensity physical activity
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Assessment method [9]
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Moderate-vigorous intensity physical activity (min/day) over the past 7 days assessed using accelerometry
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Timepoint [9]
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Week 8 post-randomisation
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Secondary outcome [10]
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Sedentary time
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Assessment method [10]
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Sedentary time (min/day) over the past 7 days assessed using accelerometry
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Timepoint [10]
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Week 8 post-randomisation
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Secondary outcome [11]
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Subjective physical activity levels
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Assessment method [11]
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Self-reported physical activity over the previous 7 days assessed using the short-form of the International Physical Activity Questionnaire (IPAQ)
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Timepoint [11]
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Weeks 8, 26 and 52 post-randomisation
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Secondary outcome [12]
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Lifestyle risk factors
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Assessment method [12]
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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)
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Timepoint [12]
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Weeks 8, 26 and 52 post-randomisation
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Secondary outcome [13]
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Blood pressure
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Assessment method [13]
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Blood pressure at rest assessed via an automated sphygmomanometer
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Timepoint [13]
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Week 8 post-randomisation
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Secondary outcome [14]
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Adverse events
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Assessment method [14]
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Adverse events assessed via self-report
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Timepoint [14]
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From randomisation to Week 8 post-randomisation
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Secondary outcome [15]
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Adherence to treatment
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Assessment method [15]
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Adherence to treatment assessed via session attendance and self-report (diary)
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Timepoint [15]
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From randomisation to Week 8 post-randomisation
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Secondary outcome [16]
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Total healthcare costs
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Assessment method [16]
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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.
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Timepoint [16]
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Weeks 8, 26 and 52 post-randomisation
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Secondary outcome [17]
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Goal attainment (goal setting arm only)
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Assessment method [17]
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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.
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Timepoint [17]
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Weeks 8, 26 and 52 post-randomisation
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
9/06/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2029
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Actual
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Sample size
Target
392
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Neuroscience Research Australia - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Neuroscience Research Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06620133
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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Matthew D Jones
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Address
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UNSW Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Matthew D Jones
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Address
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Country
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Phone
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+61 9348 0032
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06620133
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