UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057073 |
|---|---|
| Receipt number | R000065234 |
| Scientific Title | Comparison of the Effectiveness of Dry Needling and Deep Friction Massage in Low Back Pain (LBP) Patients |
| Date of disclosure of the study information | 2025/02/19 |
| Last modified on | 2025/02/19 12:20:03 |
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Basic information
Public title
Comparison of the Effectiveness of Dry Needling and Deep Friction Massage on Trigger point size, Pain Level, and Range of Motion (ROM) in Low Back Pain (LBP) Patients
Acronym
Comparison the Effect of DN and DFM on TP size, Pain Level, and ROM in LBP patients
Scientific Title
Comparison of the Effectiveness of Dry Needling and Deep Friction Massage in Low Back Pain (LBP) Patients
Scientific Title:Acronym
Comparison the Effect of DN and DFM in LBP Patients
Region
| Asia(except Japan) |
Condition
Condition
Low Back Pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the effectiveness of Dry Needling (DN) and Deep Friction Massage (DFM) in changes trigger point size, reducing pain, and improving range of motion (ROM) in LBP patients using a muscle ultrasonography-based approach.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes trigger point size, reducing pain, and improving range of motion (ROM)
Key secondary outcomes
there were significant changes between the study groups
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Dry Needling
Interventions/Control_2
Deep Friction Massage
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The sample selection process adhered to specific inclusion criteria, participants aged between 20 - 55 years, both males and females, the presence of nodules or trigger points detected via muscle ultrasonography in the back muscles, and limitations in ROM.
Key exclusion criteria
Participants exhibiting conditions such as Delayed Onset Muscle Soreness/DOMS or those who had consumed medication within five hours prior to therapy were excluded from the study.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Mujaddidah |
| Middle name | |
| Last name | Yuharti |
Organization
Hasanuddin University
Division name
Biomedical Science Study Program
Zip code
90245
Address
Andi djemma Street
TEL
+6287845006342
indahmujaddidah@gmail.com
Public contact
Name of contact person
| 1st name | Mujaddidah |
| Middle name | |
| Last name | Yuharti |
Organization
Hasanuddin University
Division name
Biomedical Science Study Program
Zip code
90245
Address
Andi djemma Street
TEL
+6287845006342
Homepage URL
indahmujaddidah@gmail.com
Sponsor or person
Institute
This research was financially supported by the 2024 BAZNAS Research Scholarship Grant.
Institute
Department
Personal name
BAZNAS Scholarship
Funding Source
Organization
BAZNAS Scholarship 2024
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Research Ethics Committee of the Faculty of Public Health, Hasanuddin University
Address
Perintis Kemerdekaan Street, KM 10
Tel
0411-585658
fkm.unhas@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 19 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065234
