UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061442 |
|---|---|
| Receipt number | R000070301 |
| Scientific Title | Comparison Dry Needling vs Electrical Dry Needling on Myofascial Trigger Points Using Ultrasonographic and Clinical Outcomes in Lumbar Myofascial Pain Syndrome: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/05/02 |
| Last modified on | 2026/05/02 10:19:06 |
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Basic information
Public title
COMPARISON OF THE DIRECT EFFECTS OF DRY NEEDLING AND ELECTRICAL DRY NEEDLING ON TRIGGER POINT AREA, FASCIA THICKNESS, PAIN, AND RANGE OF MOTION IN LUMBAR MYOFASCIAL PAIN SYNDROME
Acronym
DN-EDN Trial
Scientific Title
Comparison Dry Needling vs Electrical Dry Needling on Myofascial Trigger Points Using Ultrasonographic and Clinical Outcomes in Lumbar Myofascial Pain Syndrome: A Randomized Controlled Trial
Scientific Title:Acronym
DN-EDN RCT
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 comparative effects of dry needling and electrical dry needling on the area of MTrPs,fascia thickness,pain,and range of motion in lumbar myofascial pain syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome are Myofascial Trigger Points (MTrPs) size area and fascia thicknees using ultrasonography
Key secondary outcomes
Secondary Outcome Measures:
Pain intensity
Measured using a standardized scale (e.g., Visual Analog Scale or Numeric Rating Scale) before and after the intervention.
Range of motion (ROM)
Assessed in the lumbar region using standardized measurement techniques at pre-test and post-test.
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
| Medicine |
Interventions/Control_1
A minimally invasive therapy technique that involves inserting thin, filiform needles into trigger points in muscles experiencing myofascial pain syndrome in the lumbar region. The needles are applied directly to the muscle area, penetrating the skin and touching the trigger point. The needles are then manipulated until a local twitch response occurs. Procedure: F: 1x therapy I: 40-75 mm T: Pistoning, local twitch response (LTR) T: 3 minutes
Interventions/Control_2
A minimally invasive therapy technique similar to conventional dry needling but using a combination of Transcutaneous Electrical Neurostimulation.
Procedure:
F: 1x therapy
I: 2 Hz
T: Needles inserted into trigger points in situ + TENS stimulation
T: 10 minutes
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
Inclusion criteria are individuals aged 20 to 60 years, patients with subacute or chronic lumbar MPS, confirmed presence of myofascial trigger points and fascial thickening in the lumbar region as verified by ultrasonography, and limitation in lumbar range of motion.
Key exclusion criteria
Exclusion criteria include: (1) contraindications to needling, (2) open wounds or infection at the intervention site, (3) presence of pacemakers or implantable defibrillators, (4) pregnancy or breastfeeding, (5) history of peripheral neuropathy or progressive neurological disorders, and (6) current use of systemic anticoagulants, NSAIDs, or routine analgesics.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Meilani |
| Middle name | Meilani |
| Last name | Meilani |
Organization
Hasanuddin University
Division name
Magister Program in Biomedical Science, Postgraduate School
Zip code
90245
Address
Perintis Kemerdekaan No.10
TEL
+6282292955020
mlani4756@gmail.com
Public contact
Name of contact person
| 1st name | Meilani |
| Middle name | Meilani |
| Last name | Meilani |
Organization
Hasanuddin University
Division name
Magister Program in Biomedical Science, Postgraduate School
Zip code
90245
Address
Perintis Kemerdekaan No.10
TEL
+6282292955020
Homepage URL
mlani4756@gmail.com
Sponsor or person
Institute
Hasanuddin University
Institute
Department
Personal name
Person
Funding Source
Organization
Hasanuddin University (but independent researcher)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Indonesia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Health Research Ethics Committee, Faculty of Nursing, Hasanuddin University
Address
Perintis Kemerdekaan No.10
Tel
+6285397275009
kepk_fkepuh@unhas.ac.id
Secondary IDs
Secondary IDs
YES
Study ID_1
Ethical Approval (UH2603061)
Org. issuing International ID_1
Health Research Ethics Committee, Faculty of Nursing, Hasanuddin University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Musculoskeletal Laboratory of Physiotherapy, Hasanuddin University (Makassar)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
https://osf.io/bp467
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 | 04 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 17 | 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 | 02 | Day |
Last modified on
| 2026 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070301
