Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-05 @ 5:14 AM
Study NCT ID:
NCT05728905
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2022-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects on Pain and Function of Orthopedic Manual Therapy in Patients With Painful Disc Displacement With Reduction
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': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The assessing physiotherapist did not know to which group the patient belongs'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized single blind clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-12', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2023-02-12', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects on pain when implementing an orthopedic manual therapy intervention compared to an exercise program intervention in patients with painful disc displacement with reduction', 'timeFrame': '3 months', 'description': 'Pain prevalence within patients with disc displacement, evaluated using Visual Analogue Scale (VAS).'}, {'measure': 'Effects on function when implementing an orthopedic manual therapy intervention compared to an exercise program intervention in patients with painful disc displacement with reduction', 'timeFrame': '3 months', 'description': 'Prevalence of jaw disfunction in patients with disc displacement, assessed using Jaw Functional Limitation Scale-20.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temporomandibular Disorder', 'Manual Therapy']}, 'referencesModule': {'references': [{'pmid': '8366455', 'type': 'BACKGROUND', 'citation': 'Au AR, Klineberg IJ. Isokinetic exercise management of temporomandibular joint clicking in young adults. J Prosthet Dent. 1993 Jul;70(1):33-9. doi: 10.1016/0022-3913(93)90034-l.'}, {'pmid': '12555926', 'type': 'BACKGROUND', 'citation': 'Yoda T, Sakamoto I, Imai H, Honma Y, Shinjo Y, Takano A, Tsukahara H, Morita S, Miyamura J, Yoda Y, Sasaki Y, Tomizuka K, Takato T. A randomized controlled trial of therapeutic exercise for clicking due to disk anterior displacement with reduction in the temporomandibular joint. Cranio. 2003 Jan;21(1):10-6. doi: 10.1080/08869634.2003.11746226.'}, {'pmid': '31520538', 'type': 'BACKGROUND', 'citation': 'Wanman A, Marklund S. Treatment outcome of supervised exercise, home exercise and bite splint therapy, respectively, in patients with symptomatic disc displacement with reduction: A randomised clinical trial. J Oral Rehabil. 2020 Feb;47(2):143-149. doi: 10.1111/joor.12888. Epub 2019 Sep 30.'}, {'pmid': '26294683', 'type': 'BACKGROUND', 'citation': 'Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.'}, {'pmid': '22318373', 'type': 'BACKGROUND', 'citation': 'Craane B, Dijkstra PU, Stappaerts K, De Laat A. Randomized controlled trial on physical therapy for TMJ closed lock. J Dent Res. 2012 Apr;91(4):364-9. doi: 10.1177/0022034512438275. Epub 2012 Feb 8.'}, {'pmid': '34382921', 'type': 'BACKGROUND', 'citation': 'Campos Lopez A, De-Miguel EE, Malo-Urries M, Acedo TC. Mouth opening, jaw disability, neck disability, pressure pain thresholds, and myofascial trigger points in patients with disc displacement with reduction: A descriptive and comparative study. Cranio. 2024 May;42(3):309-315. doi: 10.1080/08869634.2021.1956214. Epub 2021 Aug 12.'}, {'pmid': '16813476', 'type': 'BACKGROUND', 'citation': 'Medlicott MS, Harris SR. A systematic review of the effectiveness of exercise, manual therapy, electrotherapy, relaxation training, and biofeedback in the management of temporomandibular disorder. Phys Ther. 2006 Jul;86(7):955-73.'}, {'pmid': '23768273', 'type': 'RESULT', 'citation': 'Tuncer AB, Ergun N, Tuncer AH, Karahan S. Effectiveness of manual therapy and home physical therapy in patients with temporomandibular disorders: A randomized controlled trial. J Bodyw Mov Ther. 2013 Jul;17(3):302-8. doi: 10.1016/j.jbmt.2012.10.006. Epub 2012 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to compare the short- and medium-term effects in pain and temporomandibular joint (TMJ) and function of implementing a manual therapy (MT) intervention treatment combined with a therapeutic exercise (TE) program, versus an isolated TE program and a non-intervention in patients with disc displacement with reduction (DDCR) with pain.', 'detailedDescription': 'Study Design: The study adopted a single-blind, randomized, controlled clinical trial approach. Adults with disc displacement with reduction clinical diagnosis, pain and loss of function were eligible for inclusion.\n\nIntervention: Patients in the study were randomized into three groups, 25 subjects to the manual therapy and therapeutic exercise group, 25 to the therapeutic exercise group and 25 to the no intervention group. Subjects were excluded if there was presence of surgical history, dentistry treatment and use of medication. The dependent variables were the presence of clicking, TMJ function, cervical disability, pain, and range of motion of the TMJ. Subjects in every group were assessed after four weeks of intervention and after eight weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Disc displacement with reduction diagnosis according to the Research Diagnostic Criteria for Temporomandibular Disorders; in the last 30 days, any TMJ noise present during the exam or clicking detected with palpation during at least one of three repetitions of jaw opening, closing, protrusion, or laterotrusion movements.\n* equal or greater than 30 mm on the VAS scale\n* Age is greater than or equal to18 years.\n\nExclusion Criteria:\n\n* Participants were excluded if they had received interventions of TMJ surgery or TMJ steroid injections in the previous month, a rheumatoid diagnosis, neurological or psychiatric diseases, or pregnancy.'}, 'identificationModule': {'nctId': 'NCT05728905', 'briefTitle': 'Effects on Pain and Function of Orthopedic Manual Therapy in Patients With Painful Disc Displacement With Reduction', 'organization': {'class': 'NETWORK', 'fullName': 'Fisioterapia Manual Ortopedica'}, 'officialTitle': 'Effects on Pain and Function When Implementing an Orthopedic Manual Therapy Intervention Compared to an Exercise Program Intervention in Patients With Painful Disc Displacement With Reduction', 'orgStudyIdInfo': {'id': 'FMO Fisioterapia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic exercise', 'description': 'The patients assigned to this group performed a self-treatment program that included three coordination exercises, two post-isometric relaxation (contraction-relaxation) and one self-traction. All exercises were performed in front of a mirror. It was performed every 3 hours, 5 times a day, for 4 weeks. The patient was instructed and supervised by a physiotherapist until they were executed correctly. All participants were provided with a video where the procedure and dosage of each exercise was described in detail.', 'interventionNames': ['Other: Therapeutic exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Therapeutic exercise + orthopedic manual therapy', 'description': 'The patients assigned to this group performed the exercise program and also received a manual therapy treatment applied by a physiotherapist. Two sessions were held per week for 4 weeks (8 sessions). Treatment consisted of traction, mobilization, and friction massage of the muscles of mastication.', 'interventionNames': ['Other: Therapeutic exercise', 'Other: Orthopedic manual therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The patients assigned to this group did not receive any type of intervention during the 4 weeks. They were asked not to change their habits or receive any other type of treatment.'}], 'interventions': [{'name': 'Therapeutic exercise', 'type': 'OTHER', 'otherNames': ['Exercise'], 'description': 'Intervention with therapeutic exercise: coordination, relaxation and disc recapture exercises.', 'armGroupLabels': ['Therapeutic exercise', 'Therapeutic exercise + orthopedic manual therapy']}, {'name': 'Orthopedic manual therapy', 'type': 'OTHER', 'otherNames': ['Physiotherapy'], 'description': 'Intervention with orthopedic manual therapy: traction, ventral sliding and massage.', 'armGroupLabels': ['Therapeutic exercise + orthopedic manual therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83150', 'city': 'Hermosillo', 'state': 'Sonora', 'country': 'Mexico', 'facility': 'Clinic', 'geoPoint': {'lat': 29.08874, 'lon': -110.96677}}], 'overallOfficials': [{'name': 'ARMANDO CAMPOS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FMO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisioterapia Manual Ortopedica', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'ARMANDO CAMPOS', 'investigatorAffiliation': 'Fisioterapia Manual Ortopedica'}}}}