| CTRI Number |
CTRI/2021/05/033493 [Registered on: 10/05/2021] Trial Registered Prospectively |
| Last Modified On: |
07/05/2021 |
| 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 Suboccipital Myofacial Release Technique on Temporomandibular Dysfunction with Neck Pain |
|
Scientific Title of Study
|
Efficacy of Sub Occipital Myofacial Release Technique on Functional Disability in Temporomandibular Dysfunction with Neck Pain: A Randomized Control Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Om Chandrakant Wadhokar |
| Designation |
MPT Student |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair
Physiotherapy College, Datta Meghe Institute of Medical Sciences, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
09158492096 |
| Fax |
|
| Email |
wadhokarom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Patil |
| Designation |
Associate Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair
Physiotherapy College, Datta Meghe Institute of Medical Sciences,
Sawangi Meghe,
Wardha
MAHARASHTRA
442001
India |
| Phone |
9975453662 |
| Fax |
|
| Email |
dvjphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratik Phansopkar |
| Designation |
Associate Professor and HOD |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair
Physiotherapy College, Datta Meghe Institute of Medical Sciences,
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9890827710 |
| Fax |
|
| Email |
drpratik77@gmail.com |
|
|
Source of Monetary or Material Support
|
| RNPC, AVBRH and Datta Meghe University Of Medical Sciences, Sawangi, Meghe, Wardha |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Medical Science Ravi Nair Physiotherapy College |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair
Physiotherapy College, Datta Meghe Institute of Medical Sciences,
Sawangi, Meghe, Wardha, Maharashtra 442001 |
| 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 |
| Om Chandrakant Wadhokar |
Acharya Vinoba Bhave Rural Hospital |
Department of
Musculoskeletal
Physiotherapy, Ravi
Nair Physiotherapy
College, Datta Meghe
Institute of Medical
Sciences, Sawangi,
Meghe, Wardha
Wardha
MAHARASHTRA |
9158492096
wadhokarom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee, RNPC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M261||Anomalies of jaw-cranial base relationship, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Stretching exercises |
Suboccipital stretching exercises 30seconds hold 3 sets was given followed by stretching for upper trapezius sternocleido mastoid. then stretching exercises 30 seconds 3 sets. followed by cervical isometrix exercises. |
| Intervention |
Sub occipital Myofacial Release Technique |
this group will be Receiving Myofacial Release Technique 1 set of 3 repetitions with 90 seconds hold for two weeks 5 times a week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
the individual must be between 18 to 50 years of age, both male and female, diagnosed with mild to moderate temporomandibular dysfunction and neck pain with forward head |
|
| ExclusionCriteria |
| Details |
individual recently undergone any dental treatment, individuals undergone recent steroid infiltration, individual undergone recent TMJ surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Maximum Mouth Opening (MMO) using 15 cm scale
2)Fonseca Questionnaire: |
All outcomes will be assessed Pre-intervention
on 1st day, Mid-intervention on 7th day and post
intervention on 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 3) Numerical Pain Rating Scale (NPRS) |
All outcomes will be assessed Pre-intervention
on 1st day, Mid-intervention on 7th day and post
intervention on 14th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
11/05/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
IT IS INTERVENTIONAL STUDY FOR COMPARISION OF MYOFACIAL RELEASE TECHNIQUE VERSUS STRETCHING TECHNIQUE IN SUBOCCIPITSL MUSCLE IN PATIENT WITH MILD TO MODERATE TEMPOROMANDIBULAR DYSFUNCTION WITH NECK PAIN NO SUCH STUDY HAS BEEN DONE DONE SO THIS STUDY WILL BE A NOVEL APROACH |