Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-25 @ 4:25 PM
Study NCT ID:
NCT06790667
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-24
First Post:
2025-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Low-Level Laser Therapy and Transcutaneous Electrical Nerve Stimulation for Myofascial Pain in Temporomandibular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants shall be randomly assigned to receive either:\n\nLow-Level Laser Therapy (LLLT), or Transcutaneous Electrical Nerve Stimulation (TENS).\n\nBoth groups will be monitored for outcomes like pain reduction and mouth opening improvement over the same timeline, with no participant switching between treatments.\n\nThis approach ensures unbiased comparison of the effectiveness of LLLT and TENS in treating myofascial pain in Temporomandibular Disorders (TMD).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-01-17', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity (VAS Score)', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Mouth Opening (Active Interincisal Distance)', 'timeFrame': '6 months', 'description': 'Change in active interincisal distance, measured using a ruler from the upper to lower incisal edges during maximum unassisted mouth opening.\n\nUnit of Measure: Millimeters (mm). Time Points: Pre-treatment, 1st week, 3rd week, and 4th week'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized clinical trial', 'temporomandibular disorder', 'myofascial pain', 'Low-level laser therapy', 'Transcutaneous Electrical Nerve Stimulation', 'Jaw Pain Treatment', 'Mouth opening improvement'], 'conditions': ['Myofascial Temporomandibular Disorders']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed cases of myofascial pain in TMD patients, which fall under diagnostic criteria (DC/TMD).\n2. Myofascial pain that persists for more than 3 months.\n3. Involvement of trigger points in the masseter and temporalis muscles.\n4. Impaired or limited mouth opening (less than 35mm).\n\nExclusion Criteria:\n\n1. Congenital abnormality or neoplastic condition around TMJ.\n2. Recent history of trauma affecting head and neck region.\n3. Patients with known dermatological disorders (eczema, psoriasis).\n4. Patients with pacemakers and cardiovascular diseases.\n5. Epileptic patients.\n6. Patients allergic to adhesive tapes or electrodes of TENS'}, 'identificationModule': {'nctId': 'NCT06790667', 'briefTitle': 'Comparison of Low-Level Laser Therapy and Transcutaneous Electrical Nerve Stimulation for Myofascial Pain in Temporomandibular Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Health Sciences Lahore'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'UNIVERSITY OF HEALTH SCIENCES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A', 'description': 'Participants in this arm will receive LLLT for the treatment of myofascial pain associated with TMD.', 'interventionNames': ['Device: Low Level Laser Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Participants in this arm will receive TENS for the treatment of myofascial pain associated with TMD.', 'interventionNames': ['Device: Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)']}], 'interventions': [{'name': 'Low Level Laser Therapy', 'type': 'DEVICE', 'description': '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).', 'armGroupLabels': ['Group A']}, {'name': 'Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Arhum Butt', 'role': 'CONTACT', 'email': 'arhum555@hotmail.com', 'phone': '+92-333-4065258'}], 'overallOfficials': [{'name': 'Arhum Butt, Bachelor of Dental Surgery', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Health Sciences Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Health Sciences Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate Resident', 'investigatorFullName': 'ARHUM BUTT', 'investigatorAffiliation': 'University of Health Sciences Lahore'}}}}