Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-29 @ 5:48 AM
Study NCT ID:
NCT04576195
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2020-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Neurophysiological Effects of PENS on Radial Nerve in Patients With Lateral Epicondylalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2020-09-28', 'studyFirstSubmitQcDate': '2020-10-05', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Pressure pain threshold using an algometer', 'timeFrame': 'Baseline and immediate (10 minutes after intervention)', 'description': 'Measurement of pressure pain threshold in the lateral epicondyle, radial nerve in the spiral groove, C5-C6 zygapophyseal joints, and the tibialis anterior muscle.'}], 'secondaryOutcomes': [{'measure': 'Changes in Pain Intensity: Visual Analogue Scale', 'timeFrame': 'Baseline and immediate (10 minutes after intervention)', 'description': 'Pain intensity measured with a 100 mm (0 - No pain - 100 The worst pain) visual analogue scale'}, {'measure': 'Changes in Pain-Free Grip Strength', 'timeFrame': 'Baseline and immediate (10 minutes after intervention)', 'description': 'Measurement the amount of force that the patient generates to the onset of pain as measured with a dynamometer'}, {'measure': 'Changes in Self-perceived Improvement between baseline and follow-up periods', 'timeFrame': 'Time Frame: Baseline,10 minutes post-intervention', 'description': 'Global ratings on changes in regards to their level of elbow well-being since the treatment on a 15-point self-report scale (from -7, very much worse, to 7, completely recover)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lateral Epicondylalgia', 'Lateral Epicondylitis', 'Lateral Elbow Tendinopathy', 'Lateral Elbow Pain', 'Percutaneous Electrical Nerve Stimulation'], 'conditions': ['Tennis Elbow']}, 'descriptionModule': {'briefSummary': 'Lateral epicondylalgia is a common musculoskeletal condition that approximately affects 1-3% of the general population. Several authors have found greater mechanical pain sensitivity in the radial nerve when compared with healthy subjects. Radial tunnel syndrome exhibits a similar clinical presentation to lateral epicondylalgia. Percutaneous electrical stimulation has shown reduce pain in several conditions. Percutaneous electrical stimulation on the radial nerve could cause an important relief in lateral epicondylalgia.\n\nHypothesis: Percutaneous electrical stimulation on radial nerve plus in patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation', 'detailedDescription': 'Randomized, double-blind, placebo controlled clinical trial, using Percutaneous Electrical Nerve Stimulation (PENS). PENS is technique to provide a transcutaneous electrical nerve stimulation current throughout needling filaments place close to the nerve.\n\nStudy Aims:\n\nAim #1: The primary aim of the study is to compare the immediate effect of a single session of PENS on pressure pain sensitivity as measured by pressure pain threshold in patients with lateral epicondylalgia with random assignment to two treatments: PENS or Sham PENS\n\nAim #2: The secondary aim of the study is to compare the immediate effect on pain free grip strength, on intensity of pain as measured by visual analogue scale (VAS) in patients with lateral epicondylalgia with random assignment to two treatments: PENS or Sham PENS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test:\n\n 1. pain during palpation of lateral epicondyle\n 2. pain on resisted wrist extension\n 3. pain on resisted middle finger extension\n 4. pain during hand-grip\n\nExclusion Criteria:\n\n* History of fractures, luxations, surgery and/or musculoskeletal disorders in upper limb.\n* Neurological disorders, inflammatory and/or degenerative diseases.\n* Having received as treatment techniques that involve needles on the previous 6 months to study enrollment, or having received percutaneous electrical stimulation as a treatment before.\n* Cervical pathology, fibromyalgia, unstable cardiovascular diseases, pregnant women or under suspect of pregnancy.\n* Contraindications of needle's insertions: anticoagulant therapy, needle phobia, diabetes, hypothyroidism, lymphoedema, muscular diseases).\n* Contraindications of electrical current application"}, 'identificationModule': {'nctId': 'NCT04576195', 'briefTitle': 'Immediate Neurophysiological Effects of PENS on Radial Nerve in Patients With Lateral Epicondylalgia', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Immediate Neurophysiological Effects of Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia', 'orgStudyIdInfo': {'id': '19/043 (b)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real PENS', 'description': 'One single session of PENS', 'interventionNames': ['Other: Real PENS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham PENS', 'description': 'One single session of Sham-PENS', 'interventionNames': ['Other: Sham PENS']}], 'interventions': [{'name': 'Real PENS', 'type': 'OTHER', 'description': "The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:\n\nNeedle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Frohse's\n\nThe percutaneous electrical stimulation will be realized with a transcutaneous electric nerve stimulation (TENS) current:\n\nTENS Frequency 2 Hz TENS Pulse width - 250 microseconds Duration - 30 minutes. TENS Intensity - Increased at an intensity of visible motor response of the innervated musculature and maximal tolerable intensity.\n\nAdministration - One single session.", 'armGroupLabels': ['Real PENS']}, {'name': 'Sham PENS', 'type': 'OTHER', 'description': "The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:\n\nNeedle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Frohse's\n\nThe electrical current will not be working, and the needles will be placed during 30 minutes:\n\n\\- Administration - One single session", 'armGroupLabels': ['Sham PENS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Complutense de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}