Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001640897
Ethics application status
Approved
Date submitted
20/11/2020
Date registered
30/11/2021
Date last updated
12/12/2022
Date data sharing statement initially provided
30/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of self-massage therapy on the sole of the foot on the back muscle flexibility, pain, stress, and disability among adults with low back pain
Scientific title
Effect of self-myofascial release on the plantar fascia in improving lumbar muscle function, pain, stress, and functional disability in adults with low back pain.
Secondary ID [1] 302584 0
Nil known
Universal Trial Number (UTN)
UTN: U1111-1271-2404
Trial acronym
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
non-specific chronic low back pain 319467 0
Condition category
Condition code
Musculoskeletal 317434 317434 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group
An experienced physiotherapist has conducted a demonstration session of self-myofascial release using a tennis ball rolling on one foot at a time.

The participants were administered with self-myofascial release to the plantar fascia using a tennis ball while seated. Participants were instructed to apply an even pressure of 6/10 (considering 0 - no pain and 10 - maximum pain) using the visual analog scale (VAS) as a guideline throughout the self-myofascial release. Incorporating the VAS in administered treatment enables some form of uniformity about pressure applied onto the plantar fascia. The rhythm of rolling at 4 beats per direction, at a rate of 70 beats per minute for a total duration of 2 minutes for each foot (Wilke et al. 2018). Participants were practiced twice a week for a period of 6 weeks.

Each participant was provided a handout specially designed for this study as a reference for the participants to continue their home exercise program.

Participants were required to record the exercises performed in an exercise diary. They were contacted by the researcher every week to review compliance and advice will be provided if participants had any concerns
Intervention code [1] 318867 0
Rehabilitation
Intervention code [2] 320785 0
Treatment: Other
Comparator / control treatment
Control group

The participants were be performing hamstring stretching, each lift and hold for 5 seconds, repeated 6 times, with no rest between repetitions.
Each participant will be instructed to perform twice a week for a period of 6 weeks.

All patients will be received reminders via phone call or WhatsApp weekly to improve exercise adherence.
Control group
Active

Outcomes
Primary outcome [1] 325467 0
the flexibility of lumbar was measured using sit to reach test
Timepoint [1] 325467 0
at baseline prior to the demonstration and 8 weeks after intervention commencement.
Secondary outcome [1] 388053 0
Pain
the pain was measured by using the Visual Analogue Scale (VAS)
Timepoint [1] 388053 0
at baseline prior to the demonstration and 8 weeks after intervention commencement.
Secondary outcome [2] 388054 0
Low back pain disability
The Oswestry Disability Index (ODI) is a self-administered questionnaire to evaluate the limitations of various daily living activities.
Timepoint [2] 388054 0
at baseline prior to the demonstration and 8 weeks after intervention commencement.
Secondary outcome [3] 388055 0
Stress
Stress level will be employed. the modified versions of the Perceived Stress Scale (PSS-10)
Timepoint [3] 388055 0
at baseline prior to the demonstration and 8 weeks after intervention commencement.

Eligibility
Key inclusion criteria
1. Individuals within the ages of 20-55 years
2. lower back pain diagnosed by Doctor within the past 6 months
3. Has acquired an office job/job requiring manual labour for more than 6 months
4. Has not received any surgical/conservative treatment prior to diagnosis
Minimum age
20 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Major Injuries of the lower limb/spine in the past 6 months (e.g. fractures, dislocations, rheumatoid arthritis, osteoarthritis, malignant tumours, infectious spine)
2. Identified health problems such as nerve involvement or compression, spinal disorders (i.e. Spondylolisthesis, Herniated nucleus pulposus)
3. Surgical interventions in the past year i.e. Total Hip Replacement and Total Knee Replacement spine operation
4. Pregnant
5. Hypermobility will judge by Beighton score (Beighton & Horan,1969)

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)
Randomization
A participant who was eligible for inclusion in the trial was allocated randomly into intervention and control group by central randomisation using a computer system..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated random number table :
Randomization was done a few times until the two groups matched for age, body mass index, and baseline measurements.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For baseline measurements, Shapiro-Wilk test was used to determine the normality of sample distribution.
Independent t-test and Mann-Whitney test were used to compare the experimental and control groups at
baseline for continuous data while Chi-square test was used for nominal data. Data was analyzed using
intention-to-treat analysis, where the baseline data was used irrespective of the lost to follow up after the
intervention. A mixed model ANOVA was used to examine the eectiveness of self myofascial release group post 8th weeks in terms of time, group and interaction eect. The signicant level was set at p < 0.05 for each statistical analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2021
Actual
9/03/2021
Date of last participant enrolment
Anticipated
1/09/2022
Actual
16/09/2022
Date of last data collection
Anticipated
14/10/2022
Actual
30/10/2022
Sample size
Target
70
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 23066 0
Malaysia
State/province [1] 23066 0
Selangor (Bandar Puncak Alam)

Funding & Sponsors
Funding source category [1] 307015 0
University
Name [1] 307015 0
Universiti Teknologi MARA Selangor
Country [1] 307015 0
Malaysia
Primary sponsor type
University
Name
Universiti Teknologi MARA
Address
Pejabat Rektor
Universiti Teknologi MARA Puncak Alam Branch,
42300 Bandar Puncak Alam
Selangor
Country
Malaysia
Secondary sponsor category [1] 307586 0
University
Name [1] 307586 0
Universiti Teknologi MARA Puncak Alam Branch,
Address [1] 307586 0
Faculty of Medicine,
Universiti Teknologi MARA Sungai Buloh Campus,
Jalan Hospital,
47000 Sungai Buloh,
Selangor
Country [1] 307586 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307146 0
UiTM RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 307146 0
Ethics committee country [1] 307146 0
Malaysia
Date submitted for ethics approval [1] 307146 0
11/11/2020
Approval date [1] 307146 0
01/02/2021
Ethics approval number [1] 307146 0
REC/01/2021 (FB/04)

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

Contacts
Principal investigator
Name 106194 0
Dr Chua Siew Kuan
Address 106194 0
Center of Physiotherapy,
Faculty of Health Sciences
Universiti Teknologi MARA Selangor,
Puncak Alam Campus
42300 Bandar Puncak Alam
Selangor
Country 106194 0
Malaysia
Phone 106194 0
+603 32584492
Fax 106194 0
+603 32584599
Email 106194 0
[email protected]
Contact person for public queries
Name 106195 0
Noor Shazreen Aieda binti Mohd Shaifuddin Azha
Address 106195 0
Center of Physiotherapy,
Faculty of Health Sciences
Universiti Teknologi MARA Selangor,
Puncak Alam Campus
42300 Bandar Puncak Alam
Selangor
Country 106195 0
Malaysia
Phone 106195 0
+6012 401 0439
Fax 106195 0
+603 32584599
Email 106195 0
[email protected]
Contact person for scientific queries
Name 106196 0
Chua Siew Kuan
Address 106196 0
Center of Physiotherapy,
Faculty of Health Sciences
Universiti Teknologi MARA Selangor,
Puncak Alam Campus
42300 Bandar Puncak Alam
Selangor
Country 106196 0
Malaysia
Phone 106196 0
+603 32584492
Fax 106196 0
+60332584599
Email 106196 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
The information of participants' data will be kept in the ‘locked cabinet’ system which provides additional safeguards at the Faculty of Health Sciences,Universiti Teknologi MARA Puncak Alam Campus whilst maintaining patient confidentiality.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13975Informed consent formThe supporting documents can be obtained by applying to the ethics committee of Universiti Teknologi MARA. https://www.recuitm.org/contato-1[email protected] -approval of the extension of data collection from... [More Details] 380784-(Uploaded-29-11-2021-16-19-58)-Study-related document.pdf
13977Ethical approvalThe supporting documents can be obtained by applying to the ethics committee of Universiti Teknologi MARA. https://www.recuitm.org/contato-1[email protected]



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.