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

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.

Sponsor

Neuroscience Research Australia

Recruitment Status

RECRUITING

Study Objective

TREATMENT

ClinicalTrials.gov ID

NCT06620133

Additional Identification number

Last Update Posted

2025-06-11

Study Completion (Actual)

2029-12-31

Study Record Versions

Contacts and Locations

facility: Neuroscience Research Australia
status: RECRUITING
city: Sydney
state: New South Wales
country: Australia
contacts: [{name=Imtiaz Desai, role=CONTACT, phone=+61 404 272 990, email=capacity@unsw.edu.au}]
geoPoint: {lat=-33.86785, lon=151.20732}

Conditions

Chronic Low Back Pain (Non-specific, Uncomplicated)

TargetDisease

id: M4714
name: Back Pain
asFound: Back Pain
relevance: HIGH

id: M19433
name: Low Back Pain
asFound: Low Back Pain
relevance: HIGH

id: M13066
name: Pain
relevance: LOW

id: M12404
name: Neurologic Manifestations
relevance: LOW

id: T1303
name: Chronic Graft Versus Host Disease
asFound: Chronic
relevance: HIGH

ProductName

IsActiveControl

IsControlDrug

IsPlacebo

ControlDrug

-

Intervention / Treatment

type: OTHER
name: Pain education and patient-led goal setting
description: 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.
armGroupLabels: [Pain education and patient-led goal setting]

type: OTHER
name: Supervised group exercise
description: 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.
armGroupLabels: [Written advice]

Intervention

Study Type

INTERVENTIONAL

Phase

NA

Allocation

RANDOMIZED

Interventional Model

PARALLEL

Subject Blind

Arm Label

Arm Type

label: Pain education and patient-led goal setting
type: EXPERIMENTAL
description: Pain education and patient-led goal setting
interventionNames: [Other: Pain education and patient-led goal setting]

label: Written advice
type: EXPERIMENTAL
description: Guideline-based written advice developed for people with chronic low back pain (e.g. https://pubmed.ncbi.nlm.nih.gov/34283182/)
interventionNames: [Other: Supervised group exercise]

NumberOfInterventionGroups

0

GroupEnrollment

Target Number of Participant

0

InstitutionLocation

InstitutionPhoneNumber

Study Site

Location Countries

Countries of recruitment

Study Start (Actual)

2025-06-09

Arm Description

Inclusion and Exclusion Criteria

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

minimum age

18 Years

maximum age

Standard ages

ADULT

OLDER_ADULT

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

NO

Enrollment (Actual)

392

Original Enrollment (Actual)

0

Final Enrollment Number

0

FinalSubjectSelectionDate

AnalysisTargetGroup

DemographicInformation

Primary Outcome Measures

measure: Pain intensity
description: Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale
timeFrame: Week 26 post-randomisation

measure: Disability
description: Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability
timeFrame: Week 26 post-randomisation

Secondary Outcome Measures

measure: Pain intensity
description: Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale
timeFrame: Weeks 8 and 52 post-randomisation

measure: Disability
description: Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability
timeFrame: Weeks 8 and 52 post-randomisation

measure: Pain self-efficacy
description: Pain self-efficacy assessed using the Pain Self-Efficacy Questionnaire (PSEQ); scale range 0-60; higher scores indicate greater pain self-efficacy
timeFrame: Weeks 8, 26 and 52 post-randomisation

measure: Back beliefs
description: 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
timeFrame: Weeks 8, 26 and 52 post-randomisation

measure: Kinesiophobia
description: 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)
timeFrame: Weeks 8, 26 and 52 post-randomisation

measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L)
description: 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).
timeFrame: Weeks 8, 26 and 52 post-randomisation

measure: Daily step count
description: Average daily step count over the past 7 days assessed using accelerometry.
timeFrame: Week 8 post-randomisation

measure: Light intensity physical activity
description: Light intensity physical activity (min/day) over the past 7 days assessed using accelerometry
timeFrame: Week 8 post-randomisation

measure: Moderate-vigorous intensity physical activity
description: Moderate-vigorous intensity physical activity (min/day) over the past 7 days assessed using accelerometry
timeFrame: Week 8 post-randomisation

measure: Sedentary time
description: Sedentary time (min/day) over the past 7 days assessed using accelerometry
timeFrame: Week 8 post-randomisation

measure: Subjective physical activity levels
description: Self-reported physical activity over the previous 7 days assessed using the short-form of the International Physical Activity Questionnaire (IPAQ)
timeFrame: Weeks 8, 26 and 52 post-randomisation

measure: Lifestyle risk factors
description: 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)
timeFrame: Weeks 8, 26 and 52 post-randomisation

measure: Blood pressure
description: Blood pressure at rest assessed via an automated sphygmomanometer
timeFrame: Week 8 post-randomisation

measure: Adverse events
description: Adverse events assessed via self-report
timeFrame: From randomisation to Week 8 post-randomisation

measure: Adherence to treatment
description: Adherence to treatment assessed via session attendance and self-report (diary)
timeFrame: From randomisation to Week 8 post-randomisation

measure: Total healthcare costs
description: 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.
timeFrame: Weeks 8, 26 and 52 post-randomisation

measure: Goal attainment (goal setting arm only)
description: 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.
timeFrame: Weeks 8, 26 and 52 post-randomisation

PrimaryEndpointResult

Primary Completion Date (Actual)

2028-12-31

ClinicalTrialResultSummary

Telephone

Address

Name

Matthew Jones

Title

Principal Investigator

Telephone

name: Matthew D Jones
role: CONTACT
phone: +61 9348 0032
email: matthew.jones@unsw.edu.au

Affiliation

Neuroscience Research Australia