| CTRI Number |
CTRI/2024/12/077655 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of PNF Vs Rocabado exercise in muscular Temporomandibular joint disorders |
|
Scientific Title of Study
|
EFFECTS OF PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION VS ROCABADO EXERCISE ON PAIN AND MAXIMAL MOUTH OPENING IN TEMPOROMANDIBULAR DYSFUNCTION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashfak Abdul Kader S |
| Designation |
Post graduate student |
| Affiliation |
Saveetha College of Physiotherapy ,Saveetha Institute of Medical And Technical Science |
| Address |
No 162,Saveetha College of Physiotherapy, Department of Physiotherapy,SIMATS, Saveetha nagar,Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9962697923 |
| Fax |
|
| Email |
afzy1771@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ASHFAK ABDUL KADER S |
| Designation |
Post Graduate student |
| Affiliation |
Saveetha College of Physiotherapy, Saveetha Institute of Medical And Technical Science |
| Address |
No 162,Saveetha College of Physiotherapy, SIMATS, Saveetha nagar,Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9962697923 |
| Fax |
|
| Email |
afzy1771@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashfak Abdul Kader S |
| Designation |
Post graduate student |
| Affiliation |
Saveetha College of Physiotherapy , Saveetha Institute of Medical And Technical Science |
| Address |
No 162,Saveetha College of Physiotherapy, SIMATS, Saveetha nagar,Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9962697923 |
| Fax |
|
| Email |
afzy1771@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and hospital,Saveetha Nagar,Thandalam, Chennai, Tamil Nadu,India -602105 |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
No 162, Saveetha Medical Hospital, Saveetha Nagar, Thandalam, Tamil Nadu,Chennai,India -602105 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ramana K |
Saveetha Medical Hospital |
No 162,Department of Physiotherapy,poonamalle highroad, Saveetha nagar,Thandalam
Chennai
TAMIL NADU |
8939925505
ramana.scpt@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional scientific review boad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M266||Temporomandibular joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Proprioceptive Neuromuscular Facilitation |
It is a facilitatory technique used to train the weak muscles.it is widely used in various conditions like stroke etc. Patient is informed about the technique , its effects
and precautions.First diagonal movement is flexion with right side rotation and right side lateral flex-ion. Then do extension with left rotation and left lateral flexion. The second Diagonal flexion with left side rotation and left side lateral flexion and extension with right side rotation and right side lateral flexion of the head and neck patterns of PNF were ap-plied. In both diagonals, the following movements were performed: mouth opening, mandibular Retrusion, tongue elevation with neck flexion, and mouth closing, man-dibular protraction, tongue depression with neck extension. All of these patterns were applied using techniques of RS and CI. Individuals with TMD were initially taught exercises with rhythmic initiation and 15 repetitions were applied as warm-up period before techniques were applied. |
| Comparator Agent |
Rocabado exercise |
It is a six set of exercise done with six repetitions, especially framed for temporomandibular joint disorders. The patient is educated about the exercise and its effects on the muscles.It consists of following exercises.Rest position of the tongue.Make a clucking sound with the tongue for 6 times. To find your normal resting position gently place the one third of tongue against the roof of the mouth behind front teeth. Breathe diaphragmatically through your nose while keeping your tongue in this resting position for six breaths.
Controlled temporomandibular joint rotation. Tongue on roof of mouth and open for 15 repetition.
Mandibular rhythmic stabilization. Apply slight resistance to opening, closing and lateral deviation with the jaw in a resting position holding for 6 seconds.
Stabilized head flexion: Nodding facilitates upper cervical flexion, as most of these patients have forward head posture resulting in upper cervical extension deviation. Nod head for 15 degree back and forth for 6 repetitions
Lower cervical retraction: Chin tuck for 6 seconds and hold.
Shoulder girdle retraction. : Pull shoulder back and down, hold for 6 seconds.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients who meets the RDC for M-TMJ dysfunction. Patients with symptoms of clenching, grinding, joint sounds. Patients with limited jaw movements. |
|
| ExclusionCriteria |
| Details |
Patients having orthopedic, neurological or hematological cervical disorders, ii) Patients receiving occlusive treatments, iii) Patients using functional appliances. Patients with mandibular joint osteoarthritis. Patients with surgical history in the jaw. Patients with vertigo. Patients with headache associated with temporal-mandibular disorders |
|
|
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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain pressure threshold, |
8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maximal Mouth Opening |
8th week |
| Jaw Function Limitation Scale |
8th week |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
16/12/2024 |
| 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="0"
Months="2"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Temporal mandibular joint disorders (TMDs) are a
multifaceted group of excruciating disorders which impact masticatory muscles
along with temporomandibular joint. TMD symptoms include jaw pain or
tenderness, aching in and around the ear, discomfort or difficulty chewing,
agonizing facial pain, joint locking, and trouble opening and closing the
mouth. Females aged 18 years and older reported higher prevalence of TMD signs
and symptoms than males. Aim and objective:. The aim is to
evaluate the effectiveness of Proprioceptive neuromuscular facilitation Vs
Rocabado exercise on pain and maximal mouth opening in muscular temporomandibular
joint disorders. Procedure: For experimental group, Exercises was given 30 minutes per day for 7 days
a week for 8 weeks. First diagonal movement is flexion with right side rotation
and right side lateral flexion. Then do extension with left rotation and left
lateral flexion. The second Diagonal flexion with left side rotation and left
side lateral flexion and extension with right side rotation and right side
lateral flexion of the head and neck patterns of PNF were applied. In both
diagonals, the following movements were performed: mouth opening, mandibular
Retrusion, tongue elevation with neck flexion, and mouth closing, mandibular
protraction, tongue depression with neck extension. All of these patterns were
applied using techniques of RS and CI. Individuals with TMD were initially
taught exercises with rhythmic initiation and 15 repetitions were applied as
warm-up period before techniques were applied. for control group, Exercises was given for
6 reps - 3 sets per day for 7 days a week for 8 weeks
Rest position of the tongue.Make a clucking sound with the tongue for 6 times. To find your normal
resting position gently place the one third of tongue against the roof of the
mouth behind front teeth. Breathe diaphragmatically through your nose while
keeping your tongue in this resting position for six breaths.
Controlled temporomandibular joint rotation. Tongue on roof of mouth and open for 15
repetition.
Mandibular rhythmic stabilization. Apply slight resistance to opening, closing and lateral deviation with the
jaw in a resting position holding for 6 seconds.
Stabilized head flexion: Nodding facilitates upper cervical flexion, as most of these patients have
forward head posture resulting in upper cervical extension deviation. Nod head
for 15 degree back and forth for 6 repetitions
Lower cervical retraction: Chin tuck for 6 seconds and hold.
Shoulder girdle retraction. : Pull shoulder back and down, hold for 6 seconds. Exercises was given for
6 reps - 3 sets per day for 7 days a week for 8 weeks
Rest position of the tongue.Make a clucking sound with the tongue for 6 times. To find your normal
resting position gently place the one third of tongue against the roof of the
mouth behind front teeth. Breathe diaphragmatically through your nose while
keeping your tongue in this resting position for six breaths.
Controlled temporomandibular joint rotation. Tongue on roof of mouth and open for 15
repetition.
Mandibular rhythmic stabilization. Apply slight resistance to opening, closing and lateral deviation with the
jaw in a resting position holding for 6 seconds.
Stabilized head flexion: Nodding facilitates upper cervical flexion, as most of these patients have
forward head posture resulting in upper cervical extension deviation. Nod head
for 15 degree back and forth for 6 repetitions
Lower cervical retraction: Chin tuck for 6 seconds and hold.
Shoulder girdle retraction. : Pull shoulder back and down, hold for 6 seconds. |