| CTRI Number |
CTRI/2024/05/066772 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of instrument on mouth opening in patients with severe neck pain |
|
Scientific Title of Study
|
Effect of Instrument assisted soft tissue mobilization on mouth opening in patients with chronic neck pain: A Randomised 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 |
Suraj Chavan |
| Designation |
PG student |
| Affiliation |
Dr. D. Y. Patil college of Physiotherapy |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
8999422263 |
| Fax |
|
| Email |
chavansuraj20000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Desai |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil college of Physiotherapy |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9890992383 |
| Fax |
|
| Email |
roopa.desai@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Suraj Chavan |
| Designation |
Pg student |
| Affiliation |
Dr. D. Y. Patil college of Physiotherapy |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
8999422263 |
| Fax |
|
| Email |
chavansuraj20000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil college of Physiotherapy Pimpri, Pune India, 411018 |
| Suraj Chavan |
|
|
Primary Sponsor
|
| Name |
Suraj Chavan Dr D Y Patil college of Physiotherapy Pimpri |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri |
| Type of Sponsor |
Other [self] |
|
|
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 Roopa Desai |
Dr. D. Y. Patil College of Physiotherapy |
Dr. D. Y. Patil college of Physiotherapy OPD Ground Floor, Pimpri, Pune 411018
Pune
MAHARASHTRA |
9890992383
roopa.desai@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of Dr. D. Y. Patil college of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M799||Soft tissue disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Instrument Assisted Soft Tissue Mobilization |
IASTM 2 sessions in a week with Hot Pack stretching and neck isometric for 5 days a week for 30 minutes duration for 4 weeks |
| Comparator Agent |
Routine Physiotherapy Exercises |
Hot Pack, stretching and neck isometric for 5 days a week for 20 minutes duration for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with chronic neck pain with difficulty in mouth opening.
At least two to three trigger points in Neck flexors and Extensors.
|
|
| ExclusionCriteria |
| Details |
Patients with cervical radiculopathy, History of neck surgery.
Diagnosis of systematic disease like Ankylosing Spondylitis, Spinal deformities.
H/O cardiovascular diseases, Neurological diseases.
Conditions contraindicated for IASTM technique like open wounds, unhealed fracture (cervical) , Skin hypersensitivity, hematoma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical pain rating scale
Vernier Caliper
|
Pre 0th week
post 4th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
not applicable
|
not applicable
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Chronic neck pain patients diagnosed with temporomandibular dysfunction often present with musculoskeletal issues characterized by pain, stiffness, and reduced range of motion in the cervical spine. This condition predominantly affects the cervical spine, but its impact can extend to adjacent anatomical structures, including the temporomandibular joint (TMJ) responsible for mouth opening. Neck pain causes cervical muscles tightness, muscles which are commonly involved are upper trapezius, SCM, Suboccipital, Scalene, and Levator Scapulae that can affect neck movements and has direct impact on craniovertebral angle. According to studies, cervical muscle tightness can limit mouth opening by affecting the kinetic chain. In such cases physiotherapy treatment mainly focuses on improvement of cervical spine range of motion and neck pain, which leads to negligence of TMJ evaluation and management. Previous literature suggest that IASTM has been proved for trigger point release in patients with chronic neck pain. There is dearth in literature regarding treatment efficacy of IASTM to release triggers points and improve mouth opening, Hence the need arises. |