Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-02-04 @ 5:56 AM
Study NCT ID:
NCT02578134
Status:
WITHDRAWN
Last Update Posted:
2016-03-15
First Post:
2015-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
US-guided Percutaneous Electrolysis (EPE®) in Plantar Fasciosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-14', 'studyFirstSubmitDate': '2015-10-14', 'studyFirstSubmitQcDate': '2015-10-14', 'lastUpdatePostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in disability before and after the intervention', 'timeFrame': 'Baseline, one week after the last session, and 3 months after the last session', 'description': 'The Foot and Ankle Ability Measure (FAAM) will be used to determine function and disability of the lower extremity induced by plantar heel pain'}], 'secondaryOutcomes': [{'measure': 'Changes in pain intensity before and after the intervention', 'timeFrame': 'Baseline, one week after the last session, and 3 months after the last session', 'description': "A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of plantar heel pain"}, {'measure': 'Changes in thickness of the plantar fascia', 'timeFrame': 'Baseline, one week after the last session, and 3 months after the last session', 'description': 'An ultrasound (US) assessment of the thickness of the plantar fascia will be conducted to determine changes in fascial tissue thickness'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Plantar Heel Pain, Plantar Fasciosis']}, 'descriptionModule': {'briefSummary': 'Scientific evidence of conservative management of individuals with plantar fasciosis is sometimes conflicting. There is evidence that regular exercise programs are effective for this pain condition. The inclusion of other therapeutic modalities is still controversial. Some authors have suggested that the use of US-guided percutaneous electrolysis (EPE®) maybe useful for the management of chronic tendinopathies; however, no study has investigated the potential placebo effect of this intervention. The objective of this randomized clinical trial is to determine the effectiveness of US-guided percutaneous electrolysis (EPE®) versus sham US-guided percutaneous electrolysis for the management of patients with plantar fasciosis for pain, function, and disability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* insidious onset of sharp pain under the plantar heel surface upon weight bearing after a period of non-weight bearing;\n* plantar heel pain which increases in the morning with the first steps after waking up;\n* symptoms decreasing with slight levels of activity, such as walking.\n\nExclusion Criteria:\n\n* prior surgery in the lower extremity;\n* diagnosis of fibromyalgia syndrome;\n* previous physical therapy interventions for the foot region in the previous 6 months\n* lidocaine or other injections in the plantar fascia for the management of pain in the previous 6 months'}, 'identificationModule': {'nctId': 'NCT02578134', 'briefTitle': 'US-guided Percutaneous Electrolysis (EPE®) in Plantar Fasciosis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Rey Juan Carlos'}, 'officialTitle': 'Effectiveness of US-guided Percutaneous Electrolysis (EPE®) Versus Placebo in Individuals With Plantar Fasciosis', 'orgStudyIdInfo': {'id': 'URJC 09-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'US-guided percutaneous electrolysis', 'description': 'Patients will receive one weekly session for 5 weeks for 5 weeks of US-guided percutaneous electrolysis. This intervention consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the plantar fascia insertion. In addition, patients will be asked for conducting a best-evidence low-load exercise programs for the intrinsic foot musculature. The exercise program will be asked to be performed on an individual basis twice every day.', 'interventionNames': ['Other: US-guided percutaneous electrolysis']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham US-guided percutaneous electrolysis', 'description': 'Patients will receive one weekly session for 5 weeks for 5 weeks of sham US-guided percutaneous electrolysis. In this case, the acupuncture needle will be inserted in the soft tissue, in this case the plantar fascia insertion without the application of the galvanic electrical current. In addition, patients will be asked for conducting a best-evidence low-load exercise programs for the intrinsic foot musculature. The exercise program will be asked to be performed on an individual basis twice every day.', 'interventionNames': ['Other: Sham US-guided percutaneous electrolysis']}], 'interventions': [{'name': 'US-guided percutaneous electrolysis', 'type': 'OTHER', 'description': 'US-guided percutaneous electrolysis consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the symptomatic insertion of the plantar fascia', 'armGroupLabels': ['US-guided percutaneous electrolysis']}, {'name': 'Sham US-guided percutaneous electrolysis', 'type': 'OTHER', 'description': 'The acupuncture needle will be inserted into the symptomatic plantar fascia but no galvanic electrical current will be applied, the equipment will be turn off. Patients will be blinded to the application of galvanic electrical current.', 'armGroupLabels': ['Sham US-guided percutaneous electrolysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28921', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Cesar Fernandez-de-Las-Peñas', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Division', 'investigatorFullName': 'César Fernández-de-las-Peñas', 'investigatorAffiliation': 'Universidad Rey Juan Carlos'}}}}