Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT04949594
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
2021-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relief of Pain in Patients With Cervical Dystonia Through the Use of Transcutaneous Electric Nerve Stimulation (TENS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014103', 'term': 'Torticollis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D004421', 'term': 'Dystonia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total score', 'timeFrame': '3 months', 'description': 'Toronto Western Spasmodic Torticollis Rating Scale (abbreviated TWSTRS) is a mixed clinician and patient rated cervical dystonia-specific scale. TWSTRS total score is scored from 0-85 (best to worst).'}], 'secondaryOutcomes': [{'measure': 'Mean change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Severity, -Disability and -Pain subscores', 'timeFrame': '3 months', 'description': 'The TWSTRS is comprised of 3 subscales : severity (range 0-35), disability (range 0-30), and pain (range 0-20), each of which is scored independently (best to worst).'}, {'measure': 'Mean change of Pain Numeric Rating Scale score', 'timeFrame': '3 months', 'description': 'Pain Numeric Rating Scale (abbreviated PNRS) is ranking 0-10, with 0 meaning "No pain" and 10 meaning "Pain as bad as you can imagine".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical dystonia', 'pain', 'TENS'], 'conditions': ['Cervical Dystonia', 'Pain']}, 'descriptionModule': {'briefSummary': "Dystonia is a chronic neurological condition that impacts the quality of life due to decreased mobility, social repercussions caused by others's perception of abnormal involuntary movement and frequent pain. Botulinum toxin has been shown to be effective in reducing pain in dystonia. However, many patients remain painful despite the injections, especially when the decrease in the effect of the latter, performed every 3 months on average. Despite frequent use of TENS in pain relief, only a few small studies studying TENS in dystonia were published and none of them reported TENS effects on dystonic pain using sensory threshold.\n\nThis study aimed to quantify the efficacy and tolerance of TENS in the indication of pain related to dystonia, focusing on cervical dystonia which is the most common form of dystonia.", 'detailedDescription': 'TENDYS (TENs use in cervical DYStonia) is an observational, prospective, single arm, monocentric study including subjects between September 2019 and July 2020 with cervical dystonia treated or not with botulinum neurotoxin (BoNT) type A at the Nancy Regional University Hospital.\n\nAll patients who benefited from a simple follow-up or injections of BoNT every 3 or 4 months for a painful cervical dystonia were proposed the use of TENS during a neurologic consultation with one of two specialist physicians trained to cervical dystonia. Patients who accepted had to give informed consent and were re-evaluated about 1 month later to ensure that pain persisted and to have a demo of TENS. The electro-stimulator was delivered to posterior cervical muscles over or close to the painful site, according to a Conventional or High frequency/Low intensity mode (Gate control). Patients were encouraged to use the machine daily, as often and long and possible, except for sleeping and driving.\n\nFollow-up assessments of pain occurred at the consultation toxin injection 3 months later and at 4 months for all patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'any patient admitted to a neurology consultation for cervical dystonia treated with botulinum toxin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient having received complete information on the organization of the research and not having objected to the exploitation of the data\n* patient admitted to neurology consultation for cervical dystonia treated with botulinum toxin\n\nExclusion Criteria:\n\n* Patient under legal protection\n* Minor patient\n* Patient refusing to give consent\n* Patient with exclusive radicular or truncal involvement\n* Missing data or absence of established reactogenic threshold'}, 'identificationModule': {'nctId': 'NCT04949594', 'acronym': 'TENDYS', 'briefTitle': 'Relief of Pain in Patients With Cervical Dystonia Through the Use of Transcutaneous Electric Nerve Stimulation (TENS)', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Relief of Pain in Patients With Cervical Dystonia Through the Use of Sensory Threshold TENS', 'orgStudyIdInfo': {'id': '2019PI213'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TENS', 'type': 'DEVICE', 'otherNames': ['transcutaneous electrical nerve stimulation'], 'description': 'application on muscles where pain is situated (cervical)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'Frismand-Kryloff', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'SOLENE FRISMAND-KRYLOFF', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}