Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05106920
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2021-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Frequency Parameter Used to Apply Ultrasound-guided Neuromodulation Percutaneous
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2021-10-23', 'studyFirstSubmitQcDate': '2021-10-23', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of pain', 'timeFrame': 'From baseline measurement up to 1 week', 'description': 'Measured by Visual Analogue Scale (0, no pain; 100, max pain)'}, {'measure': 'Owestry questionnaire', 'timeFrame': 'From baseline measurement up to 1 week', 'description': 'Lower back pain questionnaire. The final result is classified as minimal disability (0-20), moderate disability (21-40), severe disability (41-60), crippled (61-80) and bed-bound or exaggerating their symptoms (81-100).'}, {'measure': 'Range of motion', 'timeFrame': 'From baseline measurement up to 1 week', 'description': 'Measured by goniometer. Hip flexion, external and internal rotation range of motion'}, {'measure': 'Y Balance Test', 'timeFrame': 'From baseline measurement up to 1 week', 'description': 'Stability body'}, {'measure': 'Strength', 'timeFrame': 'From baseline measurement up to 1 week', 'description': 'Measured by dynamometer. Hip flexion, abduction, external and internal rotation muscle strength'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'In the daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation.\n\nIn the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of the study is to analyze that the effect of PNM on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic LBP. Forty subjects will be recruited, which will be divided into 2 groups: group 1 to which PNM will be applied to the sciatic nerve at 250 microseconds, 3 Hz) during 90 seconds; group 2 to which PNM will be applied to the sciatic nerve in at 250 microseconds, 10 Hz during 90 second. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Lower Back Pain\n* Having no other therapy\n\nExclusion Criteria:\n\n* Other pathology (discal hernia, injured limbs, neurological pathology)\n* Belenophobia'}, 'identificationModule': {'nctId': 'NCT05106920', 'acronym': 'Parameters NMP', 'briefTitle': 'Frequency Parameter Used to Apply Ultrasound-guided Neuromodulation Percutaneous', 'organization': {'class': 'OTHER', 'fullName': 'University of Seville'}, 'officialTitle': 'How we Apply Ultrasound-guided Neuromodulation in Lower Back Pain Sufferers', 'orgStudyIdInfo': {'id': 'NMP-Frequency'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NMP 3 Hz', 'description': 'Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 3 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.', 'interventionNames': ['Other: NMP']}, {'type': 'EXPERIMENTAL', 'label': 'NMP 10 Hz', 'description': 'Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 10 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.', 'interventionNames': ['Other: NMP']}], 'interventions': [{'name': 'NMP', 'type': 'OTHER', 'description': 'Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, to cause a tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.', 'armGroupLabels': ['NMP 10 Hz', 'NMP 3 Hz']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'University of Seville', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Seville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Blanca de la Cruz Torres', 'investigatorAffiliation': 'University of Seville'}}}}