Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001386527
Ethics application status
Approved
Date submitted
23/10/2024
Date registered
22/11/2024
Date last updated
22/11/2024
Date data sharing statement initially provided
22/11/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluate the feasibility and effectiveness of a pilot chronic low back program for Ezidi refugees: a waitlist-controlled study
Scientific title
Evaluate the feasibility and effectiveness of a pilot chronic low back program for Ezidi refugees: a waitlist-controlled study
Secondary ID [1] 313238 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 335542 0
Condition category
Condition code
Musculoskeletal 332112 332112 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The group program included 1x weekly 30-minutes education sessions tailored for delivery using methods appropriate to the low level of health literacy of the participants, 2x weekly 1-hour exercise classes and 1 x weekly home exercise. This program was a multi-disciplinary intervention. The education sessions included introduction to the program; information about aerobic, progressive strengthening and motor control exercises; pain; pain and physical activity; pain and pacing; chronic pain and medication; psychology in chronic pain; and nutrition and chronic pain. The education sessions were delivered by a physiotherapist, a dietitian, a pharmacist and a psychologist. The exercise program included 20 minutes of high intensity aerobic, progressive strengthening and motor control exercises. The exercise program included 20 minutes of high intensity aerobic, progressive strengthening and motor control exercises. The aerobic exercises were either treadmill or stationary bike training with the aim of achieving 50% to 85% of the individual’s age-predicted maximal heart rate. The strengthening exercises were with upper and oblique abdominals from the supine position with knees bent, lower abdominal crunches, full abdominal crunches, lifting trunk to neutral from prone position and arms in elevation, straight leg lifts toward ceiling and bridging with the exercise intensity progressed from 2 sets of 10 repetitions (weeks 1–2), 2 sets of 15 repetitions (weeks 3–4) to 3 sets of 10 repetitions (weeks 5–6) and 3 sets of 15 repetitions (weeks 7–8). For the motor control exercises, the participants were trained how to activate their transversus abdominus muscles which was facilitated by visualization techniques, verbal instruction, manual palpation and education using illustrations. Participants were instructed to complete controlled, low-level contractions, rather than maximum strength contractions. Training commenced in a low-load non-functional position (prone lying, four-point kneeling, supine lying with flexed knees). Holding time for exercises was gradually increased. Once the participants were able to perform sustained contractions in low-load postures, the exercises were progressed to functional tasks such as lifting an object, pushing a trolley, cleaning the floor, vacuuming, washing dishes and folding laundry. The exercise classes were supervised by a physiotherapist with groups of 6 participants. The total duration was 8 weeks. Assessing and monitoring was carried out by the physiotherapist at the class, and participants' attendance were recorded with a checklist for each exercise.
All participants had 8 weeks of waiting time(control) and all participants participated in the intervention(Intervention).
Intervention code [1] 329818 0
Treatment: Other
Intervention code [2] 329846 0
Rehabilitation
Comparator / control treatment
All participants had 8 weeks of waiting time(control) and all participants participated in the intervention(Intervention).
Control group
Active

Outcomes
Primary outcome [1] 339702 0
The Core Outcome Measures Index for the back tool (COMI-back)
Timepoint [1] 339702 0
The Core Outcome Measures Index for the back tool (COMI-back) was administered on enrolment into the study (T0), repeated 8 weeks after the initial assessment prior to commencement of the program (T1), immediately after the program (T2) and at the 3 months after program ended (T3).
Secondary outcome [1] 440948 0
a post program satisfaction survey
Timepoint [1] 440948 0
Immediately after the program ended

Eligibility
Key inclusion criteria
A convenience sample of all Ezidi refugee patients aged 18 years or over, referred to physiotherapy for management chronic low back pain, were invited to participate in the program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patients who had muscle strength less than 3/5 on manual muscle testing or cauda equina syndrome were excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/07/2021
Date of last participant enrolment
Anticipated
Actual
28/01/2022
Date of last data collection
Anticipated
Actual
20/09/2022
Sample size
Target
18
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317680 0
Government body
Name [1] 317680 0
Hunter New England Health
Country [1] 317680 0
Australia
Funding source category [2] 317721 0
Government body
Name [2] 317721 0
Hunter New England Health
Country [2] 317721 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Health
Address
Country
Australia
Secondary sponsor category [1] 320002 0
None
Name [1] 320002 0
Address [1] 320002 0
Country [1] 320002 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316380 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 316380 0
Ethics committee country [1] 316380 0
Australia
Date submitted for ethics approval [1] 316380 0
02/03/2021
Approval date [1] 316380 0
29/04/2021
Ethics approval number [1] 316380 0
2021/ETH00204

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137710 0
Mr Baeho Joo
Address 137710 0
Armidale Rural Referral Hospital, 226 Rusden Street, Armidale NSW 2350
Country 137710 0
Australia
Phone 137710 0
+61 0422177505
Fax 137710 0
Email 137710 0
[email protected]
Contact person for public queries
Name 137711 0
Baeho Joo
Address 137711 0
Armidale Rural Referral Hospital, 226 Rusden Street, Armidale NSW 2350
Country 137711 0
Australia
Phone 137711 0
+61 0422177505
Fax 137711 0
Email 137711 0
[email protected]
Contact person for scientific queries
Name 137712 0
Baeho Joo
Address 137712 0
Armidale Rural Referral Hospital, 226 Rusden Street, Armidale NSW 2350
Country 137712 0
Australia
Phone 137712 0
+61 0422177505
Fax 137712 0
Email 137712 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.