| CTRI Number |
CTRI/2024/12/078643 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Pilot Study on Dry Needling for Pain Relief and Improved Mouth Function in Oral Sub-Mucous Fibrosis |
|
Scientific Title of Study
|
Effects of Dry Needling on Pain, Functional Limitations and Mouth Opening in Patients with Oral Sub-Mucous Fibrosis- A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sachi Yogesh Bhuse |
| Designation |
Post Graduation Student |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advance physiotherapy Centre, Room no. 39, Sagar Floor, KLE Hospital Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi
neheru nagar, belegavi, Belgaum KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9168636151 |
| Fax |
|
| Email |
sachiiibhuse@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Peeyoosha Gurudut |
| Designation |
HOD and Professor |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advance physiotherapy Centre, Room no. 39, Sagar Floor, KLE Hospital Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi
NEHERU NAGAR, belegavi, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Peeyoosha Gurudut |
| Designation |
HOD and Professor |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advance physiotherapy Centre, Room no. 39, Sagar Floor, KLE Hospital Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi, 590010 |
|
|
Primary Sponsor
|
| Name |
KAHER institute of physiotherapy |
| Address |
KLs Dr. prabhakar Kore Hospital and Medical Research Centre, Belagavi |
| 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 |
| Dr Sachi Bhuse |
KLEs DR.Prabhakar Kore Hospital and Medical Research Centre, Belagavi |
advanced physiotherapy centre, physiotherapy OPD, department of orhtopaedics, KLE hospital, Nehru Nagar, Belagavi, Karnataka.
Belgaum
KARNATAKA |
9168636151
sachiiibhuse@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry Needling |
Dry Needling therapy will be given alternate days for 3 times for 1 week |
| Comparator Agent |
NIL |
NIl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate, between the age group of 18-60 years of all the genders
Diagnosed by OSMF grades 1 and 2 by the dentists.
Mouth range of motion up to 35 to 25 mm. |
|
| ExclusionCriteria |
| Details |
All the red flags to dry needling
Any coexisting infections around the 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
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess pain intensity using visual analog scale
To assess mouth function limitations:The jaw functional limitations scales (JFLS-20)
To assess the mouth range of motion using Vernier caliper |
Day 1 pre and post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2025 |
| Date of Study Completion (India) |
27/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Aim: To evaluate the effect of dry needling on pain, functional limitations, and mouth opening in patients with OSMF.
INCLUSION CRITERIA • Patients willing to participate, between the age group of 18 and 60 years of all the genders diagnosed by OSMF grades 1 and 2 by the dentists. • Mouth range of motion up to 35 to 25 mm.
EXCLUSION CRITERIA- • All the red flags to dry needling • Any coexisting infections around the 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
OUTCOE MEASURES To assess pain intensity using visual analog scale To assess mouth function limitations using the jaw functional limitations scales (JFLS-20). To assess the mouth range of motion using Vernier caliper
PROCEDURE Study participants will be screend for incusion and exclusion criteria. The pre and post-score will be measured.
|