Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000050550
Ethics application status
Approved
Date submitted
27/09/2023
Date registered
22/01/2024
Date last updated
22/01/2024
Date data sharing statement initially provided
22/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and effectiveness of telerehabilitation in the practice of musculoskeletal physiotherapy for adults with non-specific low back pain
Scientific title
Feasibility and effectiveness of telerehabilitation in the practice of musculoskeletal physiotherapy for adults with non-specific low back pain
Secondary ID [1] 310672 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non- Specific Low Back Pain 331585 0
Condition category
Condition code
Musculoskeletal 328312 328312 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Telerehabilitation treatment: Participant will undergo one familiarisation session about the technology device and apps setting such as Zoom apps or Google Meet with the physiotherapists during face-to-face session after the randomisation. Participants allocated to the telerehabilitation group will schedule their physiotherapy session via Zoom Apps by email or telephone with the telerehabilitation physiotherapist for the following session. Participants will received the telerehabilitation at their own homes. If participants might face internet challenges, necessary adjustments will be made. Alternative communication such as WhatApps or SMS. Additionally, appointment rescheduling is one of the alternative options too. The exercise program was designed during the consultation with physiotherapist. The intervention will be delivered over 8 weeks by a maximum total of eight Zoom session in real time with a physiotherapist. The initial consultation will last up to one hour, while subsequent consultation will be 45- 60 minutes. The physiotherapist and the participant will agree on the number of consultation and treatment sessions according to the client’s progression.

During the telerehabilitation session, a home exercise program will be designed according to the client’s individual goals, and the performance of remotely supervised exercises. The initial exercise prescription will have a dosage of ten repetitions each and perform exercises once a day. The exercise dosage and progression dosage will use in this study is based on previous literatures.

Recruitment rate will be measure during the recruitment stage of the trial. Other feasibility outcome measures such as adherence rate will be measured by the return of logbooks from the participants. For the attendance rate, the numbers of the attendance rate participants in both groups will be monitor and been record by the physiotherapists in charge in conventional physiotherapy group and telerehabilitation group.

The examples of exercises prescribed were MzKenzie approach, core stability exercises, Stretching exercises, cognitive functional therapy, patient education.

The examples of MzKenzie approach are extension in standing, flexion in lying,
The examples of core stability exercise are lumbar stabilization exercise, four point kneeling with alternative arm and leg extension exercise.
The examples of stretching exercises are double knees to chest stretch, piriformis stretch
The choice of the exercises was guided by the history, physical examination finding and physiotherapist's impression. The exercise intensity commonly is 10-15 repetitions with 10 seconds hold/ 2-3 sessions per day
Intervention code [1] 327078 0
Treatment: Other
Comparator / control treatment
All participants allocated into the usual care group (face to face physiotherapy session @ conventional physiotherapy) will have appointment scheduled as per the usual procedure in a physiotherapy unit with the physiotherapist. The exercise program will be designed during the consultation with physiotherapist via conventional physiotherapy. The intervention will be delivered over 8 weeks and guide by a maximum total of eight face to face session with a physiotherapist. The initial consultation will last up to one hour, while subsequent consultation will be 45-60 minutes. The physiotherapist and the participant will agree on the number of consultation and treatment sessions according to the client’s progression.

The examples of exercises prescribed were MzKenzie approach, core stability exercises, Stretching exercises, cognitive functional therapy, patient education.

The examples of MzKenzie approach are extension in standing, flexion in lying,
The examples of core stability exercise are lumbar stabilization exercise, four point kneeling with alternative arm and leg extension exercise.
The examples of stretching exercises are double knees to chest stretch, piriformis stretch
The choice of the exercises was guided by the history, physical examination finding and physiotherapist's impression. The exercise intensity commonly is 10-15 repetitions with 10 seconds hold/ 2-3 sessions per day .

The strategy used to assess or monitor adherence or fidelity to the comparator treatment will be measures by the return of logbooks from the participants
Control group
Active

Outcomes
Primary outcome [1] 336161 0
Each feasibility measurement will be assessed independently as primary outcome.

Recruitment rate
Timepoint [1] 336161 0
Recruitment rate will be measure during the recruitment stage of the trial only.
Primary outcome [2] 336162 0
Adherence rate
Timepoint [2] 336162 0
week 8 (post commencement of treatment)
Primary outcome [3] 336163 0
Attendance rate
Timepoint [3] 336163 0
Baseline (taken prior to commencement of treatment)
week 4 (primary endpoint)
week 8 ( post commencement of treatment)
Secondary outcome [1] 427181 0
Pain Scores (Primary outcome)
Timepoint [1] 427181 0
Baseline (taken prior to commencement of treatment)
week 4
week 8 ( post commencement of treatment)
Secondary outcome [2] 429504 0
Self-Efficacy for exercise (Primary outcome)
Timepoint [2] 429504 0
Baseline (taken prior to commencement of treatment)
week 4
week 8 ( post commencement of treatment)
Secondary outcome [3] 429505 0
Activity limitation in activity of daily living
Timepoint [3] 429505 0
Baseline (taken prior to commencement of treatment)
week 4
week 8 ( post commencement of treatment)
Secondary outcome [4] 429506 0
Fear and avoidance Belief
Timepoint [4] 429506 0
Baseline (taken prior to commencement of treatment)
week 4
week 8 ( post commencement of treatment)

Eligibility
Key inclusion criteria
1. People who are formally diagnosed with Non- specific low back pain (NSLBP) by a medical doctor
2. People without any obvious deformities affecting the trunk or upper and lower extremities.
3. People who own a smartphone/ laptop/ PC/ tablet
4. People who can read and understand Malay or English
5. People who are familiar with Google meeting platform or other video conferencing platform
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. People who have known co-morbidities or repeated history of cardiovascular disease contraindicating an exercise regime
2. Orthopaedic and/or neurological disorders that affect evaluation and treatment
3. Pregnant
4. Malignant conditions
5. Psychiatric disease
6. Previous back surgery
7. Uncorrected vision impairment
8. Uncorrected hearing impairment

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table (Block of four randomisation) created by Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data will be analysed using SPSS version 26. Descriptive analysis will be used to analyse sociodemographic, the feasibility of telerehabilitation in management of NSLBP. To investigate the effectiveness in the NSLBP management, Repeated Measure ANOVA will be used.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/10/2023
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
64
Accrual to date
20
Final
Recruitment outside Australia
Country [1] 25784 0
Malaysia
State/province [1] 25784 0

Funding & Sponsors
Funding source category [1] 314893 0
Self funded/Unfunded
Name [1] 314893 0
Lee Lee Sia
Country [1] 314893 0
Malaysia
Primary sponsor type
Individual
Name
Lee Lee Sia
Address
Miri Hospital, Jalan Cahaya, 98000 Miri, Sarawak.
Country
Malaysia
Secondary sponsor category [1] 316903 0
None
Name [1] 316903 0
Address [1] 316903 0
Country [1] 316903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313888 0
Medical Research & Ethic Committee, Ministry of Health Malaysia
Ethics committee address [1] 313888 0
Ethics committee country [1] 313888 0
Malaysia
Date submitted for ethics approval [1] 313888 0
21/03/2023
Approval date [1] 313888 0
18/08/2023
Ethics approval number [1] 313888 0
23-01170-BJL (IIR)

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

Contacts
Principal investigator
Name 129682 0
Ms Lee Lee, Sia
Address 129682 0
Hospital Miri, Jalan Cahaya, 98000 Miri, Sarawak
Country 129682 0
Malaysia
Phone 129682 0
+60178531680
Fax 129682 0
Email 129682 0
[email protected]
Contact person for public queries
Name 129683 0
Lee Lee, Sia
Address 129683 0
Hospital Miri, Jalan Cahaya, 98000 Miri, Sarawak
Country 129683 0
Malaysia
Phone 129683 0
+60178531680
Fax 129683 0
Email 129683 0
[email protected]
Contact person for scientific queries
Name 129684 0
Lee Lee, Sia
Address 129684 0
Hospital Miri, Jalan Cahaya, 98000 Miri, Sarawak
Country 129684 0
Malaysia
Phone 129684 0
+60178531680
Fax 129684 0
Email 129684 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.