| CTRI Number |
CTRI/2025/07/090513 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Dentistry Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Management of Head and Neck pain using different treatment modalities. |
|
Scientific Title of Study
|
Evaluation of efficacy of Transcutaneous Electric Nerve Stimulation, Therapeutic Ultrasound, Phonophoresis and Low level Laser Therapy in Management of Temporomandibular Disorders- A Comparative Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshita Arabbi |
| Designation |
Post Graduate |
| Affiliation |
PMNM Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology
PMNM Dental College and Hospital
Navanagar
Bagalkot
Bagalkot KARNATAKA 587103 India |
| Phone |
6364691612 |
| Fax |
|
| Email |
hkarabbi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Praveenkumar Ramdurg |
| Designation |
Professor and Head |
| Affiliation |
PMNM Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology
PMNM Dental College and Hospital
Navanagar
Bagalkot
Bagalkot KARNATAKA 587103 India |
| Phone |
8861593975 |
| Fax |
|
| Email |
praveenod@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Praveenkumar Ramdurg |
| Designation |
Professor and Head |
| Affiliation |
PMNM Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology
PMNM Dental College and Hospital
Navanagar
Bagalkot
Bagalkot KARNATAKA 587103 India |
| Phone |
8861593975 |
| Fax |
|
| Email |
praveenod@gmail.com |
|
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Source of Monetary or Material Support
|
| PMNM DENTAL COLLEGE AND HOSPITAL , BAGALKOT , KARNATAKA 587103 |
|
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Primary Sponsor
|
| Name |
The Principal |
| Address |
PMNM Dental College and Hospital
Navanagar
Bagalkot |
| Type of Sponsor |
Research institution and hospital |
|
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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 Harshita K Arabbi |
PMNM Dental College and Hospital , Navanagar, Bagalkot 587103 |
Room No 1
Department of Oral Medicine and Radiology
Bagalkot KARNATAKA |
6364691612
hkarabbi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M266||Temporomandibular joint disorders, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low level laser therapy |
Wavelength of 940nm mean output power of 2.5 W energy density of 900 J per TMJ for 6 mins |
| Intervention |
Phonophoresis |
with 1 percent Diclofenac Gel along with ultrasound gel of 1 MHz at an intensity of 1.3 Wcm2 for 10 mins |
| Intervention |
Plain Therapeutic Ultrasound |
frequency of 1Mz at an intensity of 1.3 Wcm2 for 10 mins |
| Comparator Agent |
Transcutaneous Electric nerve stimulation |
Electrodes with adjustable intensity from 10 to 15 frequency of 75hz and pulse width of 120 for 15 mins per session |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and females of Age between 20 to 50 years will be enrolled as study group.
2. Patients with history of chronic TMJ pain for more than 1 month
3. Patients under GROUP 1 Myofascial Pain and GROUP 2 Disc Displacement of RDC TMD Criteria
4. Patients who are self-willing to participate are included in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with the history of Pacemakers, recent trauma, open facial wounds, Implants in craniofacial region.
2.Patients who are under regular medications such as muscle relaxants, anti- depressants, anti- convulsant, anxiolytics.
3.Patients with history of any systemic disorders.
4. Patients with history of known allergies.
5. Patients with pain of odontogenic origin or arthrogenic pain as per (RDC/TMD Group III) 6. Patients who are previously treated with TENS, Th US, Phonophoresis, and LLT without improved conditions.
7.Females who are pregnant or lactating will be ruled out.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| The results concluded that Low Level Laser Therapy showed significant improvement in all parameters like Pain score VAS, Helkimo Dysfunctional Index , and Maximum Mouth Opening followed by subjects of Th US, and the least improvement was noted in subjects with TENS therapy |
All the above mentioned 4 modalities will be carried out for 2 times / week for 2 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
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Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hkarabbi@gmail.com].
- For how long will this data be available start date provided 22-06-2025 and end date provided 20-06-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
The Temporomandibular Joint (TMJ) is a vital anatomical structure that connects the mandible (lower jaw) to the temporal bone of the skull. TMJ has a crucial role in monitoring the mandibular movements thereby controlling various essential daily tasks such as chewing, speaking, swallowing, and facial movements. Temporomandibular Disorders (TMD) are a common musculoskeletal condition that cause significant discomfort and functional limitations. These disorders often manifest as chronic pain, joint dysfunction, & muscular stiffness, leading to difficulties in chewing, speaking, and performing daily activities. As conventional pharmacological and surgical treatments have limitations or adverse effects, there is an increasing need for effective, non-invasive therapeutic approaches for the treatment of temporomandibular disorders. Among the various physiotherapeutic modalities, Transcutaneous Electric Nerve Stimulation (TENS), Therapeutic Ultrasound (TUS), Phonophoresis, and Low-Level Laser Therapy (LLLT) have been widely utilized for pain relief and functional improvement in TMD patients. These techniques offer different mechanisms of actions, including neuromodulation (TENS), deep tissue heating (TUS), enhanced drug absorption (Phonophoresis), and photo biomodulation (LLLT), all of which contribute to pain reduction and muscle relaxation. However, despite their widespread use, there is a lack of consensus regarding their comparative effectiveness in managing TMD To assess the impact of these interventions, Visual Analog Scale (VAS) score will be utilized as outcome measures. The VAS score, on the other hand, is a validated tool for measuring subjective pain perception, providing insight into the patient’s pain experience and functional improvement. By integrating clinical (VAS) parameters, this study will provide a comprehensive evaluation of the therapeutic effectiveness of these modalities. The findings will help determine the most suitable non-invasive treatment for TMDs, contributing to evidence-based clinical decision-making and improved patient care. |