UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061650 |
|---|---|
| Receipt number | R000070539 |
| Scientific Title | Comparison of The Immediate Effect of Myofascial Release and Deep Friction Massage on Trigger Point Area, Fascia Thickness, Pain, and Range of Motion, in Lumbar Myofascial Pain Syndrome |
| Date of disclosure of the study information | 2026/05/22 |
| Last modified on | 2026/05/21 19:23:33 |
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Basic information
Public title
Comparison of Myofascial Release and Deep Friction Massage for Low Back Myofascial Pain
Acronym
MFR-DFM-LBP Study
Scientific Title
Comparison of The Immediate Effect of Myofascial Release and Deep Friction Massage on Trigger Point Area, Fascia Thickness, Pain, and Range of Motion, in Lumbar Myofascial Pain Syndrome
Scientific Title:Acronym
MFR-DFM Trial for Lumbar MPS
Region
| Asia(except Japan) |
Condition
Condition
Lumbar Myofascial Pain Syndrome
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the comparison of the immediate effects of Myofascial Release and Deep Friction Massage on the trigger point area (MTrPs), fascia thickness assessed by ultrasonography, as well as clinical outcomes including pain and range of motion in patients with lumbar myofascial pain syndrome (MPS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in trigger point area (MTrPs) and fascia thickness assessed by ultrasonography immediately before and after Myofascial Release and Deep Friction Massage interventions in patients with lumbar myofascial pain syndrome.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Myofascial Release Group
Interventions/Control_2
Deep Friction Massage Group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants diagnosed with myofascial pain syndrome in the erector spinae and lumbar multifidus muscles confirmed by ultrasonography,
Key exclusion criteria
a. Participants with a history of chronic diseases such as diabetes mellitus, rheumatoid arthritis, fractures, dislocations, history of lumbar surgery, or cancer that may affect pain perception and functional ability.
b. Pregnant women.
c. Participants currently using non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics that may influence pain assessment.
d. Participants with skin infections, open wounds, or other skin conditions in the treatment area.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Riri |
| Middle name | Nanda |
| Last name | Sanovtika |
Organization
Hasanuddin University
Division name
Postgraduate Program in Physiology
Zip code
90245
Address
Jl. Perintis Kemerdekaan KM.10, Tamalanrea, Makassar, South Sulawesi, Indonesia
TEL
087837149698
ririnanda39@gmail.com
Public contact
Name of contact person
| 1st name | Riri |
| Middle name | Nanda |
| Last name | Sanovtika |
Organization
Hasanuddin University
Division name
Postgraduate Program in Physiology
Zip code
90245
Address
Jl. Perintis Kemerdekaan KM.10, Tamalanrea, Makassar, South Sulawesi, Indonesia
TEL
087837149698
Homepage URL
ririnanda39@gmail.com
Sponsor or person
Institute
Hasanuddin University (Self-funded)
Institute
Department
Personal name
Funding Source
Organization
Hasanuddin University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical approval from the Research Ethics Committee of the Faculty of Nursing, Hasanuddin University
Address
Jl. Perintis Kemerdekaan KM.10, Tamalanrea, Makassar, South Sulawesi, Indonesia
Tel
(0411) 586200
office@unhas.ac.id
Secondary IDs
Secondary IDs
YES
Study ID_1
UH0405080
Org. issuing International ID_1
Ethical approval from the Research Ethics Committee of the Faculty of Nursing, Hasanuddin University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 21 | Day |
Last modified on
| 2026 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070539
