Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-30 @ 2:42 AM
Study NCT ID:
NCT04811495
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2021-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Physiotherapy Treatment for Temporomandibular Hyperlaxity
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-19', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range motion', 'timeFrame': '14 days', 'description': 'The range of movement in the temporomandibular joint is assessed.'}, {'measure': 'VAS', 'timeFrame': '14 days', 'description': 'Pain in the temporomandibular artiuclation measured with an algometer and VAS is assessed.'}, {'measure': 'Strength', 'timeFrame': '14 days', 'description': 'The strength of the temporomandibular joint musculature measured with an algometer is assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['range of motion, articular', 'disorders, temporomandibular joint'], 'conditions': ['Disorders, Temporomandibular Joint', 'Range of Motion, Articular']}, 'referencesModule': {'references': [{'pmid': '33732211', 'type': 'RESULT', 'citation': 'Buvinic S, Balanta-Melo J, Kupczik K, Vasquez W, Beato C, Toro-Ibacache V. Muscle-Bone Crosstalk in the Masticatory System: From Biomechanical to Molecular Interactions. Front Endocrinol (Lausanne). 2021 Mar 1;11:606947. doi: 10.3389/fendo.2020.606947. eCollection 2020.'}, {'pmid': '33730126', 'type': 'RESULT', 'citation': 'Al-Jewair T, Shibeika D, Ohrbach R. Temporomandibular Disorders and Their Association with Sleep Disorders in Adults: A Systematic Review. J Oral Facial Pain Headache. 2021 Winter;35(1):41-53. doi: 10.11607/ofph.2780.'}, {'pmid': '33723117', 'type': 'RESULT', 'citation': 'Kaya DI, Ataoglu H. Botulinum toxin treatment of temporomandibular joint pain in patients with bruxism: A prospective and randomized clinical study. Niger J Clin Pract. 2021 Mar;24(3):412-417. doi: 10.4103/njcp.njcp_251_20.'}, {'pmid': '33714614', 'type': 'RESULT', 'citation': 'Angelo DF, Moreira A, Sanz D, Sao Joao R. Hearing changes after temporomandibular joint arthroscopy: a prospective study. Int J Oral Maxillofac Surg. 2021 Nov;50(11):1491-1495. doi: 10.1016/j.ijom.2021.02.013. Epub 2021 Mar 11.'}, {'pmid': '33711819', 'type': 'RESULT', 'citation': 'Candido Dos Reis A, Theodoro de Oliveira T, Vidal CL, Borsatto MC, Lima da Costa Valente M. Effect of Auricular Acupuncture on the Reduction of Symptoms Related to Sleep Disorders, Anxiety and Temporomandibular Disorder (TMD). Altern Ther Health Med. 2021 Mar;27(2):22-26.'}, {'pmid': '33685496', 'type': 'RESULT', 'citation': 'Asquini G, Rushton A, Pitance L, Heneghan N, Falla D. The effectiveness of manual therapy applied to craniomandibular structures in the treatment of temporomandibular disorders: protocol for a systematic review. Syst Rev. 2021 Mar 8;10(1):70. doi: 10.1186/s13643-021-01623-7.'}, {'pmid': '33604763', 'type': 'RESULT', 'citation': 'Memmedova F, Emre U, Yalin OO, Dogan OC. Evaluation of temporomandibular joint disorder in headache patients. Neurol Sci. 2021 Nov;42(11):4503-4509. doi: 10.1007/s10072-021-05119-z. Epub 2021 Feb 18.'}, {'pmid': '33602632', 'type': 'RESULT', 'citation': "Castien RF, Scholten-Peeters GG. Letter to the Editor concerning 'Effects of physical therapy for temporomandibular disorders on headache pain intensity: A systematic review' by van der Meer et al. Musculoskelet Sci Pract. 2021 Jun;53:102324. doi: 10.1016/j.msksp.2021.102324. Epub 2021 Feb 16. No abstract available."}, {'pmid': '33584275', 'type': 'RESULT', 'citation': 'Wu M, Cai J, Yu Y, Hu S, Wang Y, Wu M. Therapeutic Agents for the Treatment of Temporomandibular Joint Disorders: Progress and Perspective. Front Pharmacol. 2021 Jan 29;11:596099. doi: 10.3389/fphar.2020.596099. eCollection 2020.'}, {'pmid': '33561277', 'type': 'RESULT', 'citation': 'Peixoto KO, da Silva Bezerra A, Melo RA, de Resende CMBM, de Almeida EO, Barbosa GAS. Short-Term Effect of Scalp Acupuncture on Pain, Sleep Disorders, and Quality of Life in Patients with Temporomandibular Disorders: A A Randomized Clinical Trial. Pain Med. 2021 Apr 20;22(4):905-914. doi: 10.1093/pm/pnab048.'}, {'pmid': '33554774', 'type': 'RESULT', 'citation': 'Onoda N, Mikami T, Saito N, Kobayashi T. Evaluation of oral health-related quality of life in patients with temporomandibular disorders. Cranio. 2023 Nov;41(6):486-493. doi: 10.1080/08869634.2021.1883378. Epub 2021 Feb 8.'}, {'pmid': '33231980', 'type': 'RESULT', 'citation': 'Nahian A, Mathew Jr J. Osteopathic Manipulative Treatment: Facial Muscle Energy, Direct MFR, and BLT Procedure - for TMJ Dysfunction. 2023 Feb 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564310/'}]}, 'descriptionModule': {'briefSummary': 'A 14-day physiotherapy treatment for temporomandibular joint hyperlaxity is established. Pre-intervention measurements and intermediate and end-of-treatment measurements are taken. Range of movement, algometry and muscle balance are assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman with temporomandicular joint pain for six months and diagnosed with hyperlaxity in the joint.\n\nExclusion Criteria:\n\n* Men\n* No temporomandibular joint pain or hyperlaxity'}, 'identificationModule': {'nctId': 'NCT04811495', 'briefTitle': 'Effectiveness of a Physiotherapy Treatment for Temporomandibular Hyperlaxity', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica de Ávila'}, 'officialTitle': 'Effectiveness of a Physiotherapy Treatment for Temporomandibular Hyperlaxity: a Case Report.', 'orgStudyIdInfo': {'id': '19/03/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient with temporomandibular joint disorders', 'interventionNames': ['Other: Physiotherapy treatment']}], 'interventions': [{'name': 'Physiotherapy treatment', 'type': 'OTHER', 'description': 'A treatment plan is carried out which aims to improve pain, muscle balance and range of motion of the temporomandibular joint.', 'armGroupLabels': ['patient with temporomandibular joint disorders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05005', 'city': 'Ávila', 'country': 'Spain', 'facility': 'Universidad Católica de Ávila', 'geoPoint': {'lat': 40.65724, 'lon': -4.69951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica de Ávila', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'JORGE VELAZQUEZ SAORNIL', 'investigatorAffiliation': 'Universidad Católica de Ávila'}}}}