| CTRI Number |
CTRI/2025/09/094835 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Dry needling versus percutaneous electrical nerve stimulation in patients with jaw pain |
|
Scientific Title of Study
|
Dry Needling Versus Percutaneous Electrical Nerve Stimulation
On Pain, Range Of Motion And Quality Of Life In Myogenous
Masticatory Pain –A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preshita Shah |
| Designation |
Post graduate student |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Room no 39 Advanced Physiotherapy Center Sagar Floor KLEs Dr Prabhakar Kore Hospital and Research center belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9021645645 |
| Fax |
|
| Email |
preshitashah0601@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay Kage |
| Designation |
Dean and professor |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Room no 39 Advanced Physiotherapy Center Sagar Floor KLEs Dr Prabhakar Kore Hospital and Research center
Belgaum
KARNATAKA
590010
India |
| Phone |
08669774249 |
| Fax |
|
| Email |
vijaykage@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vijay Kage |
| Designation |
Dean and professor |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Room no 39 Advanced Physiotherapy Center Sagar Floor KLEs Dr Prabhakar Kore Hospital and Research center
Belgaum
KARNATAKA
590010
India |
| Phone |
08669774249 |
| Fax |
|
| Email |
vijaykage@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Academy of higher education and research center, belagavi karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
Nehru nagar Belagavi Karnataka 590010 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Preshita Shah |
KLEs Dr Prabhakar Kore Hospital and Research center |
Nehru Nagar Belagavi 590010
Belgaum
KARNATAKA |
09021645645
preshitashah0601@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education anfd Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coventional Physiotherapy Treatment On Pain, Range Of Motion And Quality Of Life In Myogenous
Masticatory Pain (MMP) –A Randomized Controlled Trial
|
Coventional Physiotherapy Treatment On Pain, Range Of Motion And Quality Of Life In Myogenous
Masticatory Pain (MMP) will be given for 3 days pwer week for 2 weeks
|
| Intervention |
Dry Needling Versus Percutaneous Electrical Nerve Stimulation
(PENS) On Pain, Range Of Motion And Quality Of Life In Myogenous
Masticatory Pain (MMP) –A Randomized Controlled Trial
|
Percutaneous Electrical Nerve Stimulation
(PENS) On Pain, Range Of Motion And Quality Of Life In Myogenous
Masticatory Pain (MMP) will be given for 3 days per week for 2 weeks |
| Intervention |
Dry Needling Versus Percutaneous Electrical Nerve Stimulation
(PENS) On Pain, Range Of Motion And Quality Of Life In Myogenous
Masticatory Pain (MMP) –A Randomized Controlled Trial
|
Dry Needling On Pain, Range Of Motion And Quality Of Life In Myogenous
Masticatory Pain (MMP) will be given for 3 days per week for 2 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects willing to participate.
Age group between 18 to 40 years of both genders
Participants with MMP with limited mouth opening and stiffness according to the
Diagnostic Criteria for Temporomandibular Disorders
Muscle tenderness of any of the muscles of mastication.
Pain scores of NPRS less than 4
|
|
| ExclusionCriteria |
| Details |
All the red flags of dry needling.
Polyarthritis, OA and arthralgia.
Any coexisting Infections around face and neck, TMJ arthritis, occlusive disorders,
fibromyalgia or any neurologic disorder such as trigeminal neuralgia.
Any systemic sickness or simultaneous condition that could affect the orofacial area
and interfere with the study protocol.
Injuries, use of anticoagulants or medications for circulation issues, metal allergies,
and individuals with cognitive or communicative impairments that can impede the
gathering of essential data.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain severity - Numerical pain rating scale – NPRS
2. Pain pressure threshold (PPT) – Pressure algometer
3. The jaw functional limitations scales (JFLS-20)
4. Maximum Mouth opening – Vernier calliper
5. Quality of life - Oral health impact profile (OHIP-14)
|
baseline and end of two weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2025 |
| Date of Study Completion (India) |
08/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized controlled trial evaluating the effectiveness of dry needling, percutaneous electrical nerve stimulation, conventional therapy [ultrasound and Rocabado exercises] in adults aged 18 to 40 years with myogenous masticatory pain MMP. Thirty six participants will be randomly assigned to one of three groups DN plus conventional, PENS plus conventional, or conventional only, each receiving treatment on alternate days for two weeks. Assessments include pain using NPRS and pain pressure threshold, jaw function JFLS 20 and maximum mouth opening, and quality of life OHIP14, with results analyzed for statistical significance. The aim is to determine which intervention provides the greatest improvements in pain relief, jaw mobility, and quality of life, thus guiding future clinical management in MMP cases where comparative data is lacking. |