Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT03401905
Status:
COMPLETED
Last Update Posted:
2018-05-09
First Post:
2017-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Low Versus High Frequency Percutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomized list that was only known by the therapist. Subjects do not know about the treatment they were receiving.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind randomized control trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2017-12-21', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Changes on pain will be assessed during one month follow up. Baseline will be measured on the first day and one month later pain score will be reassessed.', 'description': 'Subjective feeling expressed by subjects in the area of discomfort. It will be measured by a Visual Analogue Scale, meaning a score of 0 points/centimiters "no pain" and a score of 10 points/centimiters "unbearable pain".'}], 'secondaryOutcomes': [{'measure': 'Pressure pain threshold', 'timeFrame': 'Changes on pain will be assessed during one month follow up. Baseline will be measured on the first day and one month later pain score will be reassessed.', 'description': 'Minimal amount of pressure that induces pain. An algometer will be used to measure pressure pain threshold. Units will be kilograms per square centimeter. The higher the score is, the less sensitive the area will be.'}, {'measure': 'Neck disability index.', 'timeFrame': 'Pre treatment at the beginning of the study and one month later, on the last of the follow up period.', 'description': 'Ten items questionnaire designed to asses the level of pain and self-assessment of cervical disability. The NDI (Spanish version) is composed of 10 questions related to daily functional activities. NDI presents an acceptable reliability with an intraclass correlation coeffcient (ICC) ranging from 0.50 to 0.98. It has been proposed that the clinically important difference required for NDI is seven points.'}, {'measure': 'kinesiofobia', 'timeFrame': 'Pre treatment at the beginning of the study and one month later, on the last of the follow up period.', 'description': 'Eleven items questionnaire designed to asses pain-related fear. TSK-11, Spanish version.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous electrical nerve stimulation', 'Myofascial trigger point'], 'conditions': ['Neck Pain', 'Chronic Pain', 'Myofascial Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'Comparison between high and low frequency percutaneous electrical nerve stimulation as treatment of myofascial chronic neck pain. The main hypothesis is that low frequency treatment will have more hypoalgesic effects than high frequency, and low frequency effects will last longer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neck pain of more than 6 months of evolution.\n* Pain level of more than 30 millimeter on the VAS scale.\n* Active myofascial frigger points on upper trapezius muscle.\n\nExclusion Criteria:\n\n* Upper limb radiculopathy.\n* Recent whiplash.\n* Cervicogenic dizziness.\n* Migraine.\n* Previous cervical surgery.'}, 'identificationModule': {'nctId': 'NCT03401905', 'briefTitle': 'Effects of Low Versus High Frequency Percutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Centro Universitario La Salle'}, 'officialTitle': 'Comparison and Effects of Low and High Frequency Percutaneous Electrical Nerve Stimulation on Myofascial Chronic Neck Pain Patients.', 'orgStudyIdInfo': {'id': 'CSEULS-PI-115/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low frequency', 'description': 'Percutaneous electrical nerve stimulation with frequency of 2 Hz and 120 microseconds of pulse width will be applied.', 'interventionNames': ['Procedure: Low frequency']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High frequency', 'description': 'Percutaneous electrical nerve stimulation with frequency of 120 Hz and 200 microseconds of pulse width will be applied.', 'interventionNames': ['Procedure: High frequency']}], 'interventions': [{'name': 'Low frequency', 'type': 'PROCEDURE', 'otherNames': ['Low frequency group'], 'description': 'A dry needling on trapezius muscle is performed, until two local twitch responses are obtained. The needle is kept inside the trigger point, as it will be the negative electrode, and an adhesive electrode will be added as the positive one. After that, a low frequency TENS is applied, at 2 Hz frequency and 120 microseconds of pulse width.', 'armGroupLabels': ['Low frequency']}, {'name': 'High frequency', 'type': 'PROCEDURE', 'otherNames': ['High frequency group'], 'description': 'A dry needling on trapezius muscle is performed, until two local twitch responses are obtained. The needle is kept inside the trigger point, as it will be the negative electrode, and an adhesive electrode will be added as the positive one. After that, a high frequency TENS is applied, at 12o Hz frequency and 200 microseconds of pulse width.', 'armGroupLabels': ['High frequency']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28023', 'city': 'Madrid', 'country': 'Spain', 'facility': 'CSEU La Salle', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Jose V León Hernández, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CSEU La Salle'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data collected will be used only for research objective. Once the trial have finished, data will be destroyed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Universitario La Salle', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator.', 'investigatorFullName': 'Jose Vicente Leon Hernandez', 'investigatorAffiliation': 'Centro Universitario La Salle'}}}}