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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
9/10/2024

Titles & IDs
Public title
Pain Education and Patient-led Goal Setting in Adults with Chronic Low Back Pain: a Randomised Controlled Trial
Scientific title
The Effect of Pain Education and Patient-led Goal Setting Compared to Supervised Group Exercise on Pain and Disability in Adults with Chronic Low Back Pain: a Randomised Controlled Trial
Secondary ID [1] 0 0
CAPACITY trial
Universal Trial Number (UTN)
Trial acronym
CAPACITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain (non-specific, Uncomplicated) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Pain education and patient-led goal setting
Other interventions - Supervised group exercise

Experimental: Pain education and patient-led goal setting - Pain education and patient-led goal setting

Experimental: Supervised group exercise - Supervised group exercise


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: Supervised group exercise
Participants will be asked to attend 1-2 sessions of online supervised group exercise each week for 8 weeks. The sessions will be performed in small groups (up to 8 people) and be led by a trained healthcare practitioner. The prescribed exercises will be able to be performed at home with minimal equipment and will mostly involve bodyweight resistance training targeting the major muscle groups.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain intensity
Timepoint [1] 0 0
Week 26 post-randomisation
Primary outcome [2] 0 0
Disability
Timepoint [2] 0 0
Week 26 post-randomisation
Secondary outcome [1] 0 0
Pain intensity
Timepoint [1] 0 0
Weeks 8 and 52 post-randomisation
Secondary outcome [2] 0 0
Disability
Timepoint [2] 0 0
Weeks 8 and 52 post-randomisation
Secondary outcome [3] 0 0
Pain self-efficacy
Timepoint [3] 0 0
Weeks 8, 26 and 52 post-randomisation
Secondary outcome [4] 0 0
Back beliefs
Timepoint [4] 0 0
Weeks 8, 26 and 52 post-randomisation
Secondary outcome [5] 0 0
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Timepoint [5] 0 0
Weeks 8, 26 and 52 post-randomisation
Secondary outcome [6] 0 0
Daily step count
Timepoint [6] 0 0
Week 8 post-randomisation
Secondary outcome [7] 0 0
Light intensity physical activity
Timepoint [7] 0 0
Week 8 post-randomisation
Secondary outcome [8] 0 0
Moderate-vigorous intensity physical activity
Timepoint [8] 0 0
Week 8 post-randomisation
Secondary outcome [9] 0 0
Sedentary time
Timepoint [9] 0 0
Week 8 post-randomisation
Secondary outcome [10] 0 0
Subjective physical activity levels
Timepoint [10] 0 0
Weeks 8, 26 and 52 post-randomisation
Secondary outcome [11] 0 0
Lifestyle risk factors
Timepoint [11] 0 0
Weeks 8, 26 and 52 post-randomisation
Secondary outcome [12] 0 0
Blood pressure
Timepoint [12] 0 0
Week 8 post-randomisation
Secondary outcome [13] 0 0
Adverse events
Timepoint [13] 0 0
From randomisation to Week 8 post-randomisation
Secondary outcome [14] 0 0
Adherence to treatment
Timepoint [14] 0 0
From randomisation to Week 8 post-randomisation
Secondary outcome [15] 0 0
Total healthcare costs
Timepoint [15] 0 0
Weeks 8, 26 and 52 post-randomisation
Secondary outcome [16] 0 0
Goal attainment (goal setting arm only)
Timepoint [16] 0 0
Weeks 8, 26 and 52 post-randomisation

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
392
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Neuroscience Research Australia - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Country

Ethics approval
Ethics application status

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 supervised exercise 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) supervised group exercise. Participants randomised to the pain education and patient-led goal setting group will receive 5 sessions of 45-60 min each over 8 weeks. Participants randomised to supervised group exercise will be able to attend up to 2 x 45min classes per week over 8 weeks. Both interventions will be delivered online via telehealth. Outcomes will be assessed at baseline and week 8, 26 and 52.
Trial website
https://clinicaltrials.gov/study/NCT06620133
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.
Public notes

Contacts
Principal investigator
Name 0 0
Matthew D Jones
Address 0 0
UNSW Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Matthew D Jones
Address 0 0
Country 0 0
Phone 0 0
+61 9348 0032
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06620133