Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT03395457
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2018-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tertiary Care With or Without Manual Therapy for Chronic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'pragmatic randomised control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2018-01-03', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in migraine-related disability', 'timeFrame': '12 weeks', 'description': 'Headache Impact Test (HIT6). The six-item Headache Impact Test (HIT-6) provides a global measure of adverse headache impact and is used in screening and monitoring patients. The HIT-6 items measure the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning, psychological distress and the severity of headache pain.\n\nThe final HIT-6 score is obtained from simple summation of the six items and ranges between 36 and 78, with larger scores reflecting greater impact. The categories used for interpretation of impact are: little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78).'}], 'secondaryOutcomes': [{'measure': 'Change in Migraine Specific Quality of Life Questionnaire Score (MSQoL 2.1)', 'timeFrame': '12 weeks', 'description': 'The 14-item instrument measures how migraines affect daily functioning across three domains: Role function Restrictions (7 items assessing how migraines limit one\'s daily social and work-related activities); Role function prevention (4 items assessing how migraines prevent these activities); Emotional Functional (3 items assessing the emotions associated with migraines). It uses a 6-point scale: "none of the time," "a little bit of the time," "some of the time," "a good bit of the time," "most of the time," and "all of the time," which are assigned scores of 1 to 6, respectively. Scores are computed as a sum of item responses and rescaled from a 0 to 100 scale such that higher scores indicate better quality of life.'}, {'measure': 'Headache Frequency', 'timeFrame': '12 weeks', 'description': 'Percentage of participants with reduction in headache frequency of greater than 50%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Migraine']}, 'referencesModule': {'references': [{'pmid': '30962877', 'type': 'DERIVED', 'citation': 'Odell J, Clark C, Hunnisett A, Ahmed OH, Branney J. Manual therapy for chronic migraine: a pragmatic randomised controlled trial study protocol. Chiropr Man Therap. 2019 Mar 27;27:11. doi: 10.1186/s12998-019-0232-4. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine if adding manual therapy to care as usual reduces the discomfort from chronic migraine compared to care as usual alone'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nFemale adults 18 years of age or older with a good command of English (to enable informed consent) Existing patients with chronic migraine as diagnosed by a clinical interview with a neurologist in line with the International Classification of Headache Diagnosis criteria (ICHD) Undergoing care as usual from the neurologist\n\nExclusion Criteria:\n\nCurrently having or had manual therapy for neck, shoulder in the last six weeks.\n\nHaving a condition contraindicated for manual therapy including but not limited to inflammatory disorders, severe osteoporosis and tumours.\n\nIdentification of any medical 'red flags' by the neurologist including\n\n* Evidence of any central nervous system involvement for example:\n* Facial palsy (presence of ptosis/Horner's syndrome)\n* Visual disturbance (presence of blurred vision, diplopia, hemianopia)\n* Speech disturbance (presence of dysarthria, dysphonia, dysphasia such as expressive or receptive)\n* Balance disturbance (presence of dizziness, imbalance, unsteadiness, falls)\n* Paraesthesia (presence, location such as upper limb/lower limb, face)\n* Weakness (presence, location such as upper limb/lower limb)\n* Known major psychiatric or psychological conditions not under control"}, 'identificationModule': {'nctId': 'NCT03395457', 'briefTitle': 'Tertiary Care With or Without Manual Therapy for Chronic Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Bournemouth University'}, 'officialTitle': 'A Pragmatic Randomised Controlled Trial on the Effectiveness of Manual Therapy as an Adjunct to Tertiary Management in Chronic Migraine', 'orgStudyIdInfo': {'id': 'Bournemouth 228901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Care as usual', 'description': 'This is the care provided by the neurologist for chronic migraine.', 'interventionNames': ['Drug: Care as usual']}, {'type': 'EXPERIMENTAL', 'label': 'Care as usual plus manual therapy', 'description': 'Other', 'interventionNames': ['Drug: Care as usual', 'Other: Manual Therapy']}], 'interventions': [{'name': 'Care as usual', 'type': 'DRUG', 'otherNames': ['Medication for chronic migraine'], 'description': 'Application of usual pharmacological care for chronic migraine', 'armGroupLabels': ['Care as usual', 'Care as usual plus manual therapy']}, {'name': 'Manual Therapy', 'type': 'OTHER', 'description': '5 sessions of manual therapy over 12 weeks', 'armGroupLabels': ['Care as usual plus manual therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Salford Royal NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Carol Clark, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'University Bournemouth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bournemouth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}