Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT07159867
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frequency of Hypermobility-Related Problems in Patients With Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D007593', 'term': 'Joint Instability'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint hypermobility', 'timeFrame': 'One-time assessment at baseline (Day 0, at the inclusion visit).', 'description': 'Joint mobility will be assessed according to the Beighton score using a goniometer.'}, {'measure': '5-part questionnaire', 'timeFrame': 'One-time questionnaire at baseline (Day 0, after clinical examination).', 'description': 'Participants over the age of 18 will also complete the 5-part questionnaire regarding historical hypermobility.'}], 'secondaryOutcomes': [{'measure': 'Joint pain', 'timeFrame': 'One-time questionnaire at baseline (Day 0, after clinical examination).', 'description': "The Numeric Rating Scale (NRS) is a self-assessment tool used to describe the patient's perceived pain intensity. The patient marks the intensity on a line with eleven points, ranging from 0 to 10. The endpoints represent 0 = 'no pain' and 10 = 'worst imaginable pain.'"}, {'measure': 'Temporomandibular joint problems', 'timeFrame': 'One-time questionnaire at baseline (Day 0, after clinical examination).', 'description': 'Screening questions regarding temporomandibular joint problems. The short version of the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) classification system will be used.'}, {'measure': 'Pain drawing', 'timeFrame': 'One-time questionnaire at baseline (Day 0, after clinical examination).', 'description': 'Participant marks areas of perceived pain on a schematic human body figure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anorexia nervosa', 'Joint hypermobility', 'Pain', 'Temporomandibular joint'], 'conditions': ['Anorexia Nervosa, Atypical', 'Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the frequense of generalized hypermobility and pain in patients with Anorexia Nervosa. The study further explores two main questions: (1) whether generalized hypermobility may be an explanatory factor for pain in some patients with Anorexia Nervosa, and (2) whether temporomandibular joint problems (such as instability, pain, difficulties opening the mouth, locking, or clicking) contribute to eating difficulties in certain individuals with Anorexia Nervosa.', 'detailedDescription': "Patients with eating disorder diagnosis Anorexia Nervosa, who are either currently in treatment or awaiting treatment at the Eating Disorders Center for children and young adults in Gothenburg, will be invited to participate in the study. During a single examination session, the patient's joints will be assessed to determine whether generalized hypermobility is present. At the same visit, the patient will answer questions regarding possible bodily pain and any temporomandibular joint problems. Joint mobility will be examined and assessed by a physiotherapist at the clinic. The examination follows a standardized protocol for assessing joint mobility and includes the assessment of nine specified joints."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at the Eating Disorders Center for Children and Young Adults in Gothenburg.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFemale patients Aged 13-25 years\n\nDiagnosed with:\n\n* Anorexia Nervosa (ICD-10 F50.0), or\n* Atypical Anorexia Nervosa (ICD-10 F50.1)\n* Currently receiving treatment or scheduled to receive treatment\n\nExclusion Criteria:\n\n* Severe cognitive impairment\n* Insufficient Swedish language skills that make it impossible to provide informed consent and prevent answering study questions\n* Pregnancy and up to one year postpartum'}, 'identificationModule': {'nctId': 'NCT07159867', 'briefTitle': 'Frequency of Hypermobility-Related Problems in Patients With Anorexia Nervosa', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'Frequency of Hypermobility-Related Problems in Patients With Anorexia Nervosa', 'orgStudyIdInfo': {'id': '2023-00568-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Female patients diagnosed with Anorexia Nervosa or Atypical Anorexia Nervosa, aged 13-25 years.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '416 50', 'city': 'Gothenburg', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Queen Silvias Children´s Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Elke Schubert Hjalmarsson, PhD', 'role': 'CONTACT', 'email': 'elke.schubert@vgregion.se', 'phone': '+46700824535'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Elke Schubert Hjalmarsson', 'investigatorAffiliation': 'Vastra Gotaland Region'}}}}