Myofascial Temporomandibular DisordersPhase 2NCT06790667
Comparison of Low-Level Laser Therapy and Transcutaneous Electrical Nerve Stimulation for Myofascial Pain in Temporomandibular Disorders
A Phase 2 study testing Low Level Laser Therapy and Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02) in people with Myofascial Temporomandibular Disorders, run by University of Health Sciences Lahore.
Trial summary
Myofascial pain is the most common form of temporomandibular disorder (TMD) encountered in maxillofacial practice. Treatment options range from conservative management to open surgical procedures, with physical therapies identified as the safest and most effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Temporomandibular Disorders
- What is being tested?
- Low Level Laser Therapy and Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 15 Jul 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed cases of myofascial pain in TMD patients, which fall under diagnostic criteria (DC/TMD).
- Myofascial pain that persists for more than 3 months.
- Involvement of trigger points in the masseter and temporalis muscles.
- Impaired or limited mouth opening (less than 35mm).
Who cannot join
- Congenital abnormality or neoplastic condition around TMJ.
- Recent history of trauma affecting head and neck region.
- Patients with known dermatological disorders (eczema, psoriasis).
- Patients with pacemakers and cardiovascular diseases.
- Epileptic patients.
- Patients allergic to adhesive tapes or electrodes of TENS
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Effectiveness of Low Level Laser Therapy and Transcutaneous Electrical Nerve Stimulation on Pain and Mouth Opening in Temporomandibular Disorders Based Upon Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
Myofascial pain is the most common form of temporomandibular disorder (TMD) encountered in maxillofacial practice. Treatment options range from conservative management to open surgical procedures, with physical therapies identified as the safest and most effective. Among these, transcutaneous electrical nerve stimulation (TENS) is a widely used technique, while low-level laser therapy (LLLT) is a recent therapeutic advancement. This study is designed to compare the efficacy of these two therapies, aiming to identify the more effective option.
Read the detailed description
A randomized clinical trial will be conducted at the Oral and Maxillofacial Surgery department, Punjab Dental Hospital, Lahore. Sample size of 40 patients will be selected through convenience sampling and divided into two equal groups, based on computergenerated random numbers. A written consent will be obtained from all the participants. Group A will receive LLLT, while Group B will receive TENS. The primary variables like pain score and mouth opening will be recorded preoperatively and during followup sessions. The proforma used for data collection will be designed, tailored to the needs of this study based on standard Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Both groups will receive their assigned therapies on alternate days for three weeks, with evaluations at 1st, 3rd, and 4th weeks post-treatment. All collected data will be entered into SPSS version 25 for statistical analysis. Independent sample t-test will be used to compare the mean pain score and mouth opening between the two groups. Repeated measures ANOVA will be applied to compare the primary variables in both groups on all follow-ups. P-value ≤0.05 will be considered as significant.
This study aims to offer tailored insights and practical recommendations, potentially improving patient care by providing safer and non-invasive alternatives to more invasive procedures thus enhancing overall treatment strategies. It is assumed that expected results shall be in favor of the LLLT group. Possible limitations may include failure of patients to come for multiple sessions.
- Conditions
- Myofascial Temporomandibular Disorders
- Being tested
- Low Level Laser Therapy, Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)
- Keywords
- Randomized clinical trial, temporomandibular disorder, myofascial pain, Low-level laser therapy, Transcutaneous Electrical Nerve Stimulation, Jaw Pain Treatment, Mouth opening improvement
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
Participants in this arm will receive Low-Level Laser Therapy (LLLT) using a Gallium Aluminum Arsenide (GaAlAs) semiconductor diode laser. The treatment involves a wavelength range of 650-808 nm with a power output of 775 mW. The therapy is administered by exposing tender points around the temporomandibular joint (TMJ) to the laser for 2 minutes per session. Each participant will receive treatment on alternate days (three sessions per week) over the course of three weeks. The goal is to assess the effectiveness of LLLT in reducing pain and improving mouth opening in patients with myofascial pain associated with Temporomandibular Disorders (TMD).
Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)Device
Participants in this arm will undergo Transcutaneous Electrical Nerve Stimulation (TENS), utilizing a four-electrode unit. The device will be set to deliver electrical impulses at a frequency of 150 Hz with a pulse width of 200 µs. Electrodes will be placed over the cutaneous region between the TMJ and coronoid process to stimulate the trigeminal and facial nerves. Each treatment session will last 15 minutes and occur on alternate days, three times a week for three weeks. This therapy aims to provide pain relief and improve jaw function for patients suffering from myofascial pain associated with TMD.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Participants in this arm will receive LLLT for the treatment of myofascial pain associated with TMD. Receives: Device: Low Level Laser Therapy |
| Group B | Experimental | Participants in this arm will receive TENS for the treatment of myofascial pain associated with TMD. Receives: Device: Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (VAS Score)
Change in pain intensity as measured by the Visual Analog Scale (VAS), a 10 cm scale ranging from 0 (no pain) to 10 (worst possible pain) Unit of Measure: Centimeters (cm) Time Points: Pre-treatment, 1st week, 3rd week, and 4th week.
Measured: 6 months
Mouth Opening (Active Interincisal Distance)
Change in active interincisal distance, measured using a ruler from the upper to lower incisal edges during maximum unassisted mouth opening.
Unit of Measure: Millimeters (mm). Time Points: Pre-treatment, 1st week, 3rd week, and 4th week
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Temporomandibular DisordersStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants shall be randomly assigned to receive either: Low-Level Laser Therapy (LLLT), or Transcutaneous Electrical Nerve Stimulation (TENS). Both groups will be monitored for outcomes like pain reduction and mouth opening improvement over the same timeline, with no participant switching between treatments. This approach ensures unbiased comparison of the effectiveness of LLLT and TENS in treating myofascial pain in Temporomandibular Disorders (TMD).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARHUM BUTT, University of Health Sciences Lahore
- Investigators
- Arhum Butt, Bachelor of Dental Surgery, Principal investigator, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790667
- Sponsor's protocol ID
- UNIVERSITY OF HEALTH SCIENCES
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share IPD because of ethical considerations, limited resources for data preparation, and potential risks of data misuse or misinterpretation.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Low Level Laser Therapy and Transcutaneous Electrical Nerve Stimulation on Pain and Mouth Opening in Temporomandibular Disorders Based Upon Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- ClinicalTrials.gov ID
- NCT06790667
- Acronym / sponsor ID
- UNIVERSITY OF HEALTH SCIENCES
- Conditions
- Myofascial Temporomandibular Disorders
- Keywords
- Randomized clinical trial, temporomandibular disorder, myofascial pain, Low-level laser therapy, Transcutaneous Electrical Nerve Stimulation, Jaw Pain Treatment, Mouth opening improvement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Myofascial pain is the most common form of temporomandibular disorder (TMD) encountered in maxillofacial practice. Treatment options range from conservative management to open surgical procedures, with physical therapies identified as the safest and most effective. Among these, transcutaneous electrical nerve stimulation (TENS) is a widely used technique, while low-level laser therapy (LLLT) is a recent therapeutic advancement. This study is designed to compare the efficacy of these two therapies, aiming to identify the more effective option.
Detailed description
A randomized clinical trial will be conducted at the Oral and Maxillofacial Surgery department, Punjab Dental Hospital, Lahore. Sample size of 40 patients will be selected through convenience sampling and divided into two equal groups, based on computergenerated random numbers. A written consent will be obtained from all the participants. Group A will receive LLLT, while Group B will receive TENS. The primary variables like pain score and mouth opening will be recorded preoperatively and during followup sessions. The proforma used for data collection will be designed, tailored to the needs of this study based on standard Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Both groups will receive their assigned therapies on alternate days for three weeks, with evaluations at 1st, 3rd, and 4th weeks post-treatment. All collected data will be entered into SPSS version 25 for statistical analysis. Independent sample t-test will be used to compare the mean pain score and mouth opening between the two groups. Repeated measures ANOVA will be applied to compare the primary variables in both groups on all follow-ups. P-value ≤0.05 will be considered as significant.
This study aims to offer tailored insights and practical recommendations, potentially improving patient care by providing safer and non-invasive alternatives to more invasive procedures thus enhancing overall treatment strategies. It is assumed that expected results shall be in favor of the LLLT group. Possible limitations may include failure of patients to come for multiple sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants shall be randomly assigned to receive either: Low-Level Laser Therapy (LLLT), or Transcutaneous Electrical Nerve Stimulation (TENS). Both groups will be monitored for outcomes like pain reduction and mouth opening improvement over the same timeline, with no participant switching between treatments. This approach ensures unbiased comparison of the effectiveness of LLLT and TENS in treating myofascial pain in Temporomandibular Disorders (TMD).
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Device: Low Level Laser TherapyParticipants in this arm will receive LLLT for the treatment of myofascial pain associated with TMD. |
| Group B | Experimental | Device: Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)Participants in this arm will receive TENS for the treatment of myofascial pain associated with TMD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed cases of myofascial pain in TMD patients, which fall under diagnostic criteria (DC/TMD).
- Myofascial pain that persists for more than 3 months.
- Involvement of trigger points in the masseter and temporalis muscles.
- Impaired or limited mouth opening (less than 35mm).
Key exclusion criteria (6 listed)
- Congenital abnormality or neoplastic condition around TMJ.
- Recent history of trauma affecting head and neck region.
- Patients with known dermatological disorders (eczema, psoriasis).
- Patients with pacemakers and cardiovascular diseases.
- Epileptic patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level Laser TherapyParticipants in this arm will receive Low-Level Laser Therapy (LLLT) using a Gallium Aluminum Arsenide (GaAlAs) semiconductor diode laser. The treatment involves a wavelength range of 650-808 nm with a power output of 775 mW. The therapy is administered by exposing tender points around the temporomandibular joint (TMJ) to the laser for 2 minutes per session. Each participant will receive treatment on alternate days (three sessions per week) over the course of three weeks. The goal is to assess the effectiveness of LLLT in reducing pain and improving mouth opening in patients with myofascial pain associated with Temporomandibular Disorders (TMD). | Device | Group A |
| Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)Participants in this arm will undergo Transcutaneous Electrical Nerve Stimulation (TENS), utilizing a four-electrode unit. The device will be set to deliver electrical impulses at a frequency of 150 Hz with a pulse width of 200 µs. Electrodes will be placed over the cutaneous region between the TMJ and coronoid process to stimulate the trigeminal and facial nerves. Each treatment session will last 15 minutes and occur on alternate days, three times a week for three weeks. This therapy aims to provide pain relief and improve jaw function for patients suffering from myofascial pain associated with TMD. | Device | Group B |
Primary outcome
Pain Intensity (VAS Score)
Time frame: 6 months
Change in pain intensity as measured by the Visual Analog Scale (VAS), a 10 cm scale ranging from 0 (no pain) to 10 (worst possible pain) Unit of Measure: Centimeters (cm) Time Points: Pre-treatment, 1st week, 3rd week, and 4th week.
Mouth Opening (Active Interincisal Distance)
Time frame: 6 months
Change in active interincisal distance, measured using a ruler from the upper to lower incisal edges during maximum unassisted mouth opening. Unit of Measure: Millimeters (mm). Time Points: Pre-treatment, 1st week, 3rd week, and 4th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No. This study does not plan to share IPD because of ethical considerations, limited resources for data preparation, and potential risks of data misuse or misinterpretation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arhum Butt, Bachelor of Dental Surgery principal investigator
University of Health Sciences Lahore
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low Level Laser Therapy and Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02) in people with Myofascial Temporomandibular Disorders, run by University of Health Sciences Lahore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arhum Butt (+92-333-4065258, arhum555@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (VAS Score) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.