Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-30 @ 1:11 PM
Study NCT ID:
NCT04198532
Status:
COMPLETED
Last Update Posted:
2019-12-26
First Post:
2019-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast Bath and Sympathetic Skin Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-24', 'studyFirstSubmitDate': '2019-12-12', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sympathetic skin response', 'timeFrame': '1 day', 'description': 'microvolts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Sympathetic Disorder']}, 'referencesModule': {'references': [{'pmid': '33135537', 'type': 'DERIVED', 'citation': 'Yavuz Keles B, Onder B, Kesiktas FN, Ones K, Paker N. Acute effects of contrast bath on sympathetic skin response in patients with poststroke complex regional pain syndrome. Somatosens Mot Res. 2020 Dec;37(4):320-325. doi: 10.1080/08990220.2020.1830756. Epub 2020 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of contrast bath on sympathetic skin response in stroke patients with complex regional pain syndrome .', 'detailedDescription': "Contrast bath(CB) is a thermal modality. It is usually performed by keeping hands in hot and cold water for certain periods of time. CB is a mostly advised intervention in complex regional pain syndrome (CRPS) altough there is no certain evidence The investigators will study on stroke patients. Change in sympathetic skin response after the contrast bath will be evaluated.\n\nStroke patients who admitted to the inpatient rehabilitation programme in Istanbul Physical Medicine and Rehabilitation Training and Research Hospital were evaluated for this study. Patients who had CRPS after stroke were included in the study (CRPS group). Also patients who had not CRPS and had similar age, gender and stroke duration with CRPS group were included in control group. Stroke patients with pacemaker, polyneuropathy, neglect, sensory or motor aphasia, peripheral nerve injury, hand surgery and reynauld disease were excluded from the study.\n\nAge, gender, dominant arm, comorbidities, stroke side, aetiology and duration were recorded. Brunnstrom stages were used to evaluate arm and hand. Spasticity of upper extremity was assed by modified aschworth scale.\n\nIn CRPS group, CRPS severity scale was performed to evaluate the CRPS severity. This scale includes sensorial, autonomic and motor function. Also, neuropathic pain was assesed by Douleur Neuropathique 4 (DN4) Questionnaire and visual analog scale(VAS).\n\nContrast bath was performed to patients' plegic side . There were two baths , one include hot water and other had cold degrees. Patients hold their plegic hands in hot water for 4 minutes, in cold water for 1 minute after hot water. Hot and cold bath were repeated four times.\n\nSympathetic skin response (SSR) was measured before the contrast bath and 30 minutes after the contrast bath finished. SSR was recorded from plegic side and contralateral side. The active electrode was placed at the palm of the hand and the reference electrode at dorsum of the hand to record the median nerve SSR. The latency and the amplitude of SSR was measured."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stroke\n* both gender\n\nExclusion Criteria:\n\n* peripheral neuropathy\n* pace maker\n* skin lesion in hands\n* anxiety\n* sensory or motor aphasia\n* peripheral nerve injury\n* hand surgery and\n* reynauld disease'}, 'identificationModule': {'nctId': 'NCT04198532', 'briefTitle': 'Contrast Bath and Sympathetic Skin Response', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}, 'officialTitle': 'Effects of Contrast Bath on Sympathetic Skin Response in Patients With Complex Regional Pain Syndrome Type 1', 'orgStudyIdInfo': {'id': 'IstPMRTRHCRPSCB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Complex Regional Pain Syndrome(CRPS) group', 'description': 'Stroke patients with complex regional pain syndrome', 'interventionNames': ['Other: Contrast bath']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Stroke patients without complex regional pain syndrome', 'interventionNames': ['Other: Contrast bath']}], 'interventions': [{'name': 'Contrast bath', 'type': 'OTHER', 'description': 'Contrast bath (hot and cold therapy)', 'armGroupLabels': ['Complex Regional Pain Syndrome(CRPS) group', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Physical Medicine and Rehabilitation Training and research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul PMR Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Betul Yavuz Keles, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul PMR training and research hospital'}, {'name': 'Burcu Onder, Assoc prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul PMR training and research hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}