Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT06365151
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2024-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-04-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2024-04-11', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'catastrophizing', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'The Pain Catastrophizing scale (PCS), evaluates the degree og catastrophic thinking gdue to pain.It is a 13-item scale, with a total range from 0 to 52. Higher scores are associated with a greater degree of pain catastrophizing.'}, {'measure': 'functional limitation', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'evaluated with tue short version of the Jaw functional limitation scale (JFLS-8). Evaluates the functional status of the masticatory system. Questionnaire with 8 items, each with a scale from 0 to 10. A higher score suggests a greater limitation.'}, {'measure': 'functional status, disability and pain', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'collected in the craniofacial pain and disability inventory (CFPDI). Self administered questionnaire of 21 items. Each item is scored on a Likert scale from 0 to 3.'}, {'measure': 'pain and tinnitus', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'evaluated with a visual analog scale (VAS). Scale from 0 to 10, where 0 indicates no pain and 10 the worst pain imaginable.'}, {'measure': 'myofascial trigger points', 'timeFrame': 'From enrollment to 4 weeks', 'description': 'presence of a palpable tight band, presence of a hyperirritable tenderpoint within te tight band, local twitch response elicited by acute palpation of the tight band, and presence refered pain in response ot trigger point compression.'}, {'measure': 'Range of motion', 'timeFrame': 'From enrollment to 4 weeks', 'description': 'measurements taken with a ruler: maximum opening, maximun active opening without pain and lateralization.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['temporomandibular joint disorders', 'fibromyalgia', 'Osteopathic medicine', 'chronic pain', 'musculoskeletal manipulations'], 'conditions': ['Fibromyalgia', 'Temporomandibular Disorder']}, 'descriptionModule': {'briefSummary': 'Nowadays, fibromyalgia is the rheumatic disorder with the highest levels of deterioration in quality of life. Among the comorbidities it presents, one of the most frequent is temporomandibular disorders. A randomized clinical study will be conducted to evaluate the effectiveness of an osteopathic manual therapy approach algorithm in a group of patients with fibromyalgia and temporomandibular disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* be diagnosed as suffering from fibromyalgia,\n* present moderate pain or dysfunction of more than 3 months' duration in the temporomandibular joint,\n* be over 18 years old,\n* understand Spanish and/or Catalan correctly,\n* and read and accept the informed consent form\n\nExclusion Criteria:\n\n* history of trauma or recent surgery to the head, face or neck;\n* systemic, rheumatic or central nervous system diseases;\n* diagnosis of malignant tumors or cancer in the orofacial region;\n* participate in other studies at the same time."}, 'identificationModule': {'nctId': 'NCT06365151', 'briefTitle': 'An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Universitat de Lleida'}, 'officialTitle': 'Effectiveness of an Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': 'TMDs fibromyalgia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'treatment will be carried out following a previously validated approach algorithm.\n\nArticulatory techniques, soft tissue mobilization techniques, trigger point inhibition, etc. will be used.', 'interventionNames': ['Other: Osteopathic manual therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham', 'description': 'A sham treatment will be performed following a previously validated approach algorithm.\n\ntechniques will be simulated in such a way that they will have no therapeutic effect.', 'interventionNames': ['Other: Sham osteopathic manual therapy']}], 'interventions': [{'name': 'Osteopathic manual therapy', 'type': 'OTHER', 'description': 'osteopathic manual treatment aimed at improving the function and pain of the temporomandibular joint.', 'armGroupLabels': ['experimental']}, {'name': 'Sham osteopathic manual therapy', 'type': 'OTHER', 'description': 'a sham osteopathic manual treatment without therapeutic effect', 'armGroupLabels': ['sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08940', 'city': 'Cornellà de Llobregat', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Llanos de la Iglesia, MsC', 'role': 'CONTACT', 'email': 'llanos.delaiglesia@gmail.com', 'phone': '+34679536992'}], 'facility': 'Osteopatia i Fisioteràpia Cornellà', 'geoPoint': {'lat': 41.35, 'lon': 2.08333}}], 'centralContacts': [{'name': 'Llanos de la Iglesia, MsC', 'role': 'CONTACT', 'email': 'llanos.delaiglesia@gmail.com', 'phone': '+4679536992'}, {'name': 'Llanos de la Iglesia', 'role': 'CONTACT', 'email': 'llanos.delaiglesia@gmail.com', 'phone': '+34679536992'}], 'overallOfficials': [{'name': 'Llanos de la Iglesia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departament de infermeria i fisioterapia. universitat de Lleida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat de Lleida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Llanos de la Iglesia', 'investigatorAffiliation': 'Universitat de Lleida'}}}}