| CTRI Number |
CTRI/2026/02/103314 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Physiotherapy Treatments for Jaw Joint Pain and Movement Problems |
|
Scientific Title of Study
|
Effect of Maitland Mobilization Versus Muscle Energy Technique in Patients with Temporomandibular Joint Dysfunction: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeraj Athavale PT |
| Designation |
Professor |
| Affiliation |
School of Physiotherapy, Pune Bharati vidyapeeth (Deemed to be University) |
| Address |
School of Physiotherapy, Pune Bharati Vidyapeeth (Deemed to be University) Dhankawadi, Pune- Satara Road, Pune
Pune MAHARASHTRA 411043 India |
| Phone |
9960097409 |
| Fax |
|
| Email |
drneeraj86@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neeraj Athavale PT |
| Designation |
Professor |
| Affiliation |
School of Physiotherapy, Pune Bharati vidyapeeth (Deemed to be University) |
| Address |
School of Physiotherapy, Pune Bharati Vidyapeeth (Deemed to be University) Dhankawadi, Pune- Satara Road, Pune
Pune MAHARASHTRA 411043 India |
| Phone |
9960097409 |
| Fax |
|
| Email |
drneeraj86@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rachana Dabadghav |
| Designation |
Assistant Professor |
| Affiliation |
School of Physiotherapy Pune, Bharati Vidyapeeth Deemed to be University |
| Address |
School of Physiotherapy, Pune, Bharati Vidyapeeth (Deemed to be University) Dhankawadi, Pune- Satara Road, Pune
Pune MAHARASHTRA 411043 India |
| Phone |
9923173525 |
| Fax |
|
| Email |
rachanadabadghav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) Dhankawadi, Pune- Satara Road, Pune 411043 |
|
|
Primary Sponsor
|
| Name |
School of Physiotherapy Pune, Bharati Vidyapeeth (Deemed to be University) |
| Address |
Bharati Vidyapeeth (Deemed to be University) Dhankawadi, Pune- Satara Road, Pune 411043 |
| Type of Sponsor |
Other [Physiotherapy 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 Neeraj Athavale |
Physiotherapy OPD |
Physiotherapy OPD, Ground floor, Bharati Hospital and Research centre, Dhankawadi, Pune- Satara road, Pune-411043 Pune MAHARASHTRA |
9960097409
dr.neeraj86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth ( Deemed to be University) Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M278||Other specified diseases of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Maitland mobilization in addition to TENS and exercises |
The patient will be positioned in a supine position with the arms and legs adequately supported. The therapist will stand opposite the joint to be treated. The technique will be performed by placing the thumbs over the lower molars while the remaining fingers will be comfortably clasped around the patient’s mandible. An oscillatory Grade IV TMJ Maitland mobilization will be administered.
The following glides will be applied based on the identified restriction:
Distraction
Distraction with anterior glide
Distraction with anterior glide and lateral glide (right/left)
Lateral glide without distraction
Each glide will be performed three times. Each procedure will last 60 seconds and will be separated by a 10-second interval. |
| Intervention |
Group B: MET in addition to TENS and exercises |
Group B will receive the post-isometric relaxation muscle energy technique. The subject will be positioned in a supine lying position. The therapist will place the thumbs on the lower molars bilaterally while stabilizing the mandible. The subject will be instructed to close the jaw using approximately 30% of maximal voluntary effort while the therapist will apply equal counter-resistance to ensure that no joint movement occurs.
After a 7-second isometric contraction, the subject will be asked to relax the jaw, following which the therapist will gently open the jaw to the maximum pain-free range possible. This procedure will be repeated five times. |
| Comparator Agent |
Group C: TENS and exercises only |
Group C will receive TENS therapy along with therapeutic exercises. Before the application of TENS, the therapist will thoroughly evaluate the patient for any contraindications. Patients will be positioned in a side-lying position with the arms and legs adequately supported.
Carbon electrodes (40 mm × 54 mm) will be placed over the affected side of the masseter muscle. TENS will be administered at a frequency of 50 Hz with a pulse width of 0.5 milliseconds. The intensity will be adjusted according to the patient’s tolerance. The treatment will be given for 10 for 6 days.
TMD Exercise Protocol:
All patients will also undergo a temporomandibular disorder exercise protocol. Each exercise will be performed six times.
1. The resting position of the tongue will be achieved by placing the tip of the tongue on the upper palate just behind the front teeth. The patient will perform diaphragmatic breathing through the nose while producing a clicking sound with the tongue, ensuring no movement of accessory respiratory muscles.
2. The mouth will be opened slowly to facilitate TMJ rotation, with the tongue maintained in the resting position to prevent anterior translation of the condyle.
3. While maintaining the tongue in the resting position, resistance will be applied using the index finger to left lateral deviation of the chin as well as during opening and closing movements of the jaw.
4. With the body maintained in an upright position and the hand placed over the C2–C7 region at the posterior aspect of the neck, the patient will be trained to perform craniocervical flexion.
5. With the body in an upright position and the eyes and ears maintained at the same horizontal level, upper cervical flexion and lower cervical extension will be performed, followed by cervical retraction through backward head movement.
6. With the body maintained in an upright position, shoulder girdle retraction and depression will be performed without altering the position of the cervical spine.
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both males and females with pain in the TMJ, reduced mouth opening for more than one month due to conditions like trismus, fibromyalgia, bruxism, patients having undergone maxillofacial surgeries after submaxillary space infection, post-operative cases of zygomatic arch fracture, or mandible fracture |
|
| ExclusionCriteria |
| Details |
Patients with Degenerative TMJ arthritis, malignant tumours of the face and jaw, a history of TMJ dislocation, hypermobile TMJ, and missing lower premolar or molar teeth |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain using the visual analogue scale (VAS) |
before the treatment and reassessed after 2 weeks, i.e., 6 sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| maximal mouth opening (MMO) |
before the treatment and reassessed after 2 weeks, i.e., 6 sessions |
| Functional disability was measured by the Fonesca Anamnestic Index (FAI) |
before the treatment and reassessed after 2 weeks, i.e., 6 sessions |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2026 |
| Date of Study Completion (India) |
30/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Temporomandibular joint dysfunction (TMD) is a common
musculoskeletal disorder characterized by jaw pain, restricted mouth opening,
joint sounds, and functional limitations. Owing to its multifactorial etiology,
conservative physiotherapy management—particularly manual therapy—is considered
the first line of treatment. Maitland mobilization and Muscle Energy Technique
(MET) are frequently used techniques, but evidence directly comparing their
effectiveness in TMD is limited.
This randomized controlled trial aims to compare the effects
of Maitland mobilization and MET on pain, maximal mouth opening, and functional
disability in patients with TMD. A total of 45 participants (aged 19–60 years)
diagnosed with TMD will be randomly allocated into three groups:
Group A: Maitland mobilization + TENS + exercises
Group B: MET + TENS + exercises
Group C: TENS + exercises
Intervention will be given for two weeks (6 sessions).
Outcomes will be assessed pre- and post-intervention using the Visual Analogue
Scale (VAS), Maximal Mouth Opening (MMO), and Fonseca Anamnestic Index (FAI).
Data will be analyzed using SPSS version 25.0 with
appropriate parametric and non-parametric tests. The study aims to provide
evidence-based guidance on the relative effectiveness of Maitland mobilization
and MET in the physiotherapy management of temporomandibular joint dysfunction.
|