Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-25 @ 4:55 PM
Study NCT ID:
NCT03425903
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2018-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Clinical Efficacy of Whole Body Cryotherapy in the Cryosense Cabin for the Treatment of 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All participants received WBC sessions and after that become controls'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-01', 'studyFirstSubmitDate': '2018-01-25', 'studyFirstSubmitQcDate': '2018-02-01', 'lastUpdatePostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibromyalgia Impact Questionnaire (FIQ)', 'timeFrame': '8 weeks', 'description': 'This instrument composed of 10 items, measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week.'}], 'secondaryOutcomes': [{'measure': 'Combined Index of Severity of Fibromyalgia (ICAF)', 'timeFrame': '8 weeks', 'description': 'Composed of 59 items, measures the combined severity index of fibromyalgia divided into 4 factors: physical, emotional, social and active and passive coping'}, {'measure': 'General health questionnaire (SF36)', 'timeFrame': '8 weeks', 'description': 'It´s composed of 36 questions (items) that assess both positive and negative health states'}, {'measure': 'Pain intensity measure. Visual Analogyc scale (VAS)', 'timeFrame': '8 weeks', 'description': 'Each patien marks in the scale the pain intensity scored 0-10 (0= no pain; 10= pain as can be)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromyalgia, Whole body cryotherapy'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '30353267', 'type': 'DERIVED', 'citation': 'Rivera J, Tercero MJ, Salas JS, Gimeno JH, Alejo JS. The effect of cryotherapy on fibromyalgia: a randomised clinical trial carried out in a cryosauna cabin. Rheumatol Int. 2018 Dec;38(12):2243-2250. doi: 10.1007/s00296-018-4176-0. Epub 2018 Oct 23.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness of an intervention with sessions of 3 minutes of whole body cryotherapy (WBC) in the Cryosense cabin. Measurement period time: 8 weeks.', 'detailedDescription': 'The aim of this study is to evaluate the effectiveness of an intervention with sessions of 3 minutes of whole body cryotherapy (WBC) in the Cryosense cabin, on the main clinical manifestations of patients with Fibromyalgia (FM).\n\nA randomized, open and crossed 8-week clinical trial comparing a WBC intervention with the waiting list control group. Patients diagnosed with FM according to ACR 2010 criteria, in treatment and regular follow-up recruited consecutively. Two groups were made, one of intervention and one of waiting list which served as control during the first phase. At the end of the first phase, and after a week of washout, the groups crossed and went on to carry out the second phase following the opposite intervention. The pharmacological treatment was not modified during the entire study.\n\nTrial endpoints were changed in pain after 2 and 4 weeks, measured by a visual analogue scale (VAS) and burden of disease, evaluated by the Fibromyalgia Impact Questionnaire(FIQ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 25 and 80 years old\n* Diagnosis of Fibromyalgia according to ACR criteria\n* More than 1 year from diagnosis\n* Lack of response or partial response to previous treatment\n* In case of women,commitment not to get pregnant during the study.\n\nExclusion Criteria:\n\n* Patiens with cardiovascular or psychiatric comorbidity\n* Cold intolerance\n* Changes in pharmacological treatment during the study\n* Body temperature over 37,5ºC'}, 'identificationModule': {'nctId': 'NCT03425903', 'briefTitle': 'Evaluate the Clinical Efficacy of Whole Body Cryotherapy in the Cryosense Cabin for the Treatment of Fibromyalgia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tecnología e Innovación Médico Estética S.L.'}, 'officialTitle': 'Clinical Research, Randomized, Open, Unmasked, Controlled, Cross-group, Active-treatment, to Evaluate the Clinical Efficacy of Whole Body Cryotherapy (WBC) in the Cryosense TCT Cabin for the Treatment of Fibromyalgia', 'orgStudyIdInfo': {'id': 'TIME-CRY-2015-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Whole Body Cryotherapy sessions', 'description': "10 Whole Body Cryotherapy sessions administered on alternate days. Patient fills the questionaires and then comes into the cabin wearing only underwear. The door is closed and the session begins, with the release of nitrogen gas to the cabin indoors, which will be in contact with the patient's body surface for 3 minutes. The intervention is performed on alternate days, so 3 sessions per week are administered. Afterwards will be compared when intervening as an control group without sessions, and with 3 visits per week and fills in the questionnaires", 'interventionNames': ['Device: Whole body cryotherapy sessions']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Without sessions. Patient attends a control visit weekly, for 3 consecutive weeks and fills in the questionnaires to control the variables while treatment is not applied. Afterwards will be compared when intervening as an intervention group receiving 3 sessions per week and fills in the questionnaires.'}], 'interventions': [{'name': 'Whole body cryotherapy sessions', 'type': 'DEVICE', 'description': 'Whole body cryotherapy (WBC) 10 sessions of 3 minutes at a temperature of -196ºC (point of evaporation of liquid nitrogen), on the basis of three sessions a week.Fills in questionnaires.', 'armGroupLabels': ['Whole Body Cryotherapy sessions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Tecnología e Innovación Médico Estética', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Javier Rivera, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Gregorio Marañón-IPR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tecnología e Innovación Médico Estética S.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}