Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT03641495
Status:
COMPLETED
Last Update Posted:
2021-03-26
First Post:
2018-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Education and Therapeutic Exercise for Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-23', 'studyFirstSubmitDate': '2018-08-16', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity: VAS', 'timeFrame': 'Baseline', 'description': 'The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) pre-intervention at baseline'}, {'measure': 'Pain Intensity: VAS', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) at the end of the intervention'}, {'measure': 'Fibromyalgia Impact Questionnaire', 'timeFrame': 'Baseline', 'description': 'The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) pre-intervention at baseline'}, {'measure': 'Fibromyalgia Impact Questionnaire', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) at the end of the intervention'}], 'secondaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': 'Baseline', 'description': 'The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) pre-intervention at baseline'}, {'measure': 'Fatigue', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) at the end of the intervention'}, {'measure': 'Quality of Sleep', 'timeFrame': 'Baseline', 'description': 'The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline'}, {'measure': 'Quality of Sleep: Pittsburg Sleeping Questionnaire', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at the end of the intervention'}, {'measure': 'Functional Capacity', 'timeFrame': 'Baseline', 'description': 'The investigators measure the functional capacity with Senior Fitness Test at baseline'}, {'measure': 'Functional Capacity', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the functional capacity with Senior Fitness Test at the end of treatment'}, {'measure': 'body strength', 'timeFrame': 'baseline', 'description': 'The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at baseline'}, {'measure': 'body strength', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at the end of treatment'}, {'measure': 'Pressure pain threshold', 'timeFrame': 'baseline', 'description': 'The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at baseline'}, {'measure': 'Pressure pain threshold', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at the end of treatment'}, {'measure': 'Anxiety and Depression', 'timeFrame': 'Baseline', 'description': 'The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at baseline'}, {'measure': 'Anxiety and Depression', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at the end of the intervention'}, {'measure': 'kinesiophobia', 'timeFrame': 'baseline', 'description': 'The investigators measure the kinesiophobia with TAMPA questionnaire at baseline'}, {'measure': 'kinesiophobia', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the kinesiophobia with TAMPA questionnaire at the end of treatment'}, {'measure': 'Quality of life: HAQ', 'timeFrame': 'baseline', 'description': 'The investigators measure the quality of life with Health Assessment Questionnaire (HAQ) at baseline'}, {'measure': 'Quality of life: HAQ', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the quality of life with ( Health Assessment Questionnaire (HAQ) at the end of treatment'}, {'measure': 'Central sensitization', 'timeFrame': 'baseline', 'description': 'The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline'}, {'measure': 'Central sensitization', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at the end of treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fibromyalgia', 'therapeutic exercise', 'physiotherapy'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and psychological problems. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients.\n\nThe objective of this trial is to evaluate if patient education plus therapeutic exercise is more effective in pain intensity, fatigue, function, strength, pain threshold, anxiety, depression, quality of life, quality of sleep, kinesiophobia, pain coping and biochemical and genetic markers and compared to therapeutic exercise.\n\nFor this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).\n\nPatients included are randomized into 2 groups one receive education of pain neurophysiology plus exercise therapy and the other only exercise therapy. Groups receive 3 treatment sessions a week over 10 weeks.\n\nThe variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed medically with Fibromyalgia\n* Diagnosed according to the American College of Rheumatology criteria\n* Agreement to attend to treatment sessions\n\nExclusion Criteria:\n\n* Any kind of contraindications for physical activity\n* Other kind of diseases that could limit the intervention\n* Previous surgery last year\n* Medication modifications in the last 3 months'}, 'identificationModule': {'nctId': 'NCT03641495', 'briefTitle': 'Pain Education and Therapeutic Exercise for Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Zaragoza'}, 'officialTitle': 'Effects of Pain Education and Therapeutic Exercise for Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': 'University of Valladolid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain education plus exercise therapy (PE + ET)', 'description': 'Pain education according to the book "Explain Pain" written by Lorimer Moseley and David Butler\n\nExercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.', 'interventionNames': ['Other: PE+ET']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise therapy (ET)', 'description': 'Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.', 'interventionNames': ['Other: ET']}], 'interventions': [{'name': 'PE+ET', 'type': 'OTHER', 'description': 'To explain the physiology of nervous system and the mechanism and modulation of acute and chronic pain.\n\nTo perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.', 'armGroupLabels': ['Pain education plus exercise therapy (PE + ET)']}, {'name': 'ET', 'type': 'OTHER', 'description': 'To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.', 'armGroupLabels': ['Exercise therapy (ET)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42004', 'city': 'Soria', 'country': 'Spain', 'facility': 'Sandra Jiménez del Barrio', 'geoPoint': {'lat': 41.76401, 'lon': -2.46883}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The patient data were confidential and were assigned a number to each patient to maintain confidentiality'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Valladolid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sandra Jiménez', 'investigatorAffiliation': 'Universidad de Zaragoza'}}}}