Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-03 @ 8:18 PM
Study NCT ID:
NCT03020693
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2016-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar Fasciitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036981', 'term': 'Fasciitis, Plantar'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000079245', 'term': 'Dry Needling'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-11', 'studyFirstSubmitDate': '2016-12-28', 'studyFirstSubmitQcDate': '2017-01-11', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in pain scores on the visual analogue scale at 6 weeks in patients with plantar fasciitis.', 'timeFrame': '6 weeks', 'description': 'It will evaluate the pain with Visual Analogue Scale in the first step in the first and tenth session. At 6 weeks, a new measurement will be made.'}], 'secondaryOutcomes': [{'measure': 'Change in strength scores at 6 weeks from first session in patients with plantar fasciitis.', 'timeFrame': '6 weeks', 'description': 'It will evaluate the strength using dynamometer in the first and tenth session. At 6 weeks, a new measurement will be made.'}, {'measure': 'Change in the pain in the Trigger points at 6 weeks from first session in patients with plantar fasciitis.', 'timeFrame': '6 weeks', 'description': 'It will evaluate the pain with algometer in the first and tenth session in the plantar muscle. It will measure the change of pain in the Trigger points in the plantar muscle. At 6 weeks, a new measurement will be made .Three measurements will be made and the average data will be recorded.'}, {'measure': 'Change in the functionality of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.', 'timeFrame': '6 weeks', 'description': 'It will evaluate the functionality using Foot and Ankle Ability Measure questionnaire (FAAM) in the first and tenth session. At 6 weeks, a new measurement will be made.'}, {'measure': 'Change in the functionality and quality of life of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.', 'timeFrame': '6 weeks', 'description': 'It will evaluate the functionality and quality of life using Foot Health Status Questionnaire (FHSQ) in the first and tenth session. At 6 weeks, a new measurement will be made.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['electrostimulation', 'exercise program'], 'conditions': ['Fasciitis, Plantar']}, 'referencesModule': {'references': [{'pmid': '27526703', 'type': 'BACKGROUND', 'citation': 'Thiagarajah AG. How effective is acupuncture for reducing pain due to plantar fasciitis? Singapore Med J. 2017 Feb;58(2):92-97. doi: 10.11622/smedj.2016143. Epub 2016 Aug 16.'}, {'pmid': '27683642', 'type': 'RESULT', 'citation': 'Eftekharsadat B, Babaei-Ghazani A, Zeinolabedinzadeh V. Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial. Med J Islam Repub Iran. 2016 Jul 23;30:401. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of an electrostimulation treatment with TENS using a needle and a surface electrode combined with an exercise program to fasciitis plantar. Half participants will receive invasive electrostimulation (TENS using a needle) and exercises while the other half will receive electrostimulation placebo and exercises.', 'detailedDescription': 'There are a lot of treatments to fasciitis plantar. Exercises are the treatments more recommended to fasciitis plantar but not all patients improve only with exercises. Dry needling is recommended to relieve the pain in the heel. TENS is used to decrease the pain in the fasciitis plantar. Investigators will apply to half participants a treatment that combines TENS + Dry needling (invasive electrostimulation ) with exercises while the other half receive electrostimulation placebo (TENS using surface electrodes with non-therapeutic intensity) + exercises.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical diagnosis of plantar fasciitis\n* Age equal or superior to 18 years old.\n* VAS minimum of 2 points int the first steps after a prolonged decreasing period.\n* Having an evolution of a month or more of pain.\n* Not having received acupuncture or dry needling as treatment.\n\nExclusion Criteria:\n\n* Peripheral Neuropathies.\n* Tarsus tunnel syndrome.\n* Rheumatic diseases.\n* Contraindication to dry needling: nickel allergy, fear of needles, sky with erosions.\n* Clotting disorders such as thrombosis or thrombophlebitis.\n* Fractures, infections and/ or tumor processes.\n* Have been treated for plantar fasciitis in the las 4 weeks.\n* Previous surgery in the foot\n* Pregnancy.\n* Communication Disorders.\n* Holders of pacemakers or electrostimulators.'}, 'identificationModule': {'nctId': 'NCT03020693', 'briefTitle': 'Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar Fasciitis', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar. A Clinical Trial', 'orgStudyIdInfo': {'id': 'PI-2015-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Invasive electrostimulation combined with exercises.', 'description': 'Dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to therapeutic intensity) combined with exercises program.', 'interventionNames': ['Procedure: Invasive electrostimulation combined with exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo electrostimulation and exercises.', 'description': 'Sham dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to non-therapeutic intensity) with surface electrodes combined with exercises program.', 'interventionNames': ['Procedure: Placebo electrostimulation and exercises']}], 'interventions': [{'name': 'Invasive electrostimulation combined with exercises', 'type': 'PROCEDURE', 'otherNames': ['dry needling with TENS'], 'description': 'Procedure for producing analgesia by introducing the TENS current through a needle combined with a exercises program.', 'armGroupLabels': ['Invasive electrostimulation combined with exercises.']}, {'name': 'Placebo electrostimulation and exercises', 'type': 'PROCEDURE', 'otherNames': ['Non-invasive electrostimulation combined with exercises'], 'description': 'First: Sham dry needling. After: electrostimulation using surfaces electrodes. Finally a exercises program.', 'armGroupLabels': ['Placebo electrostimulation and exercises.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28834', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundacion Hospital Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}