Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-02 @ 5:57 AM
Study NCT ID:
NCT02496351
Status:
UNKNOWN
Last Update Posted:
2015-07-15
First Post:
2015-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TENS for Phantom Limb Pain Prevention Following Major Amputation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010591', 'term': 'Phantom Limb'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-14', 'studyFirstSubmitDate': '2015-07-09', 'studyFirstSubmitQcDate': '2015-07-09', 'lastUpdatePostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PREOPERATIVE PAIN EVALUATION', 'timeFrame': '3 days before intervention', 'description': 'Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10 DN4 Test ( for neurophatic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neurophatic pain.'}, {'measure': 'PREOPERATIVE NEUROPAThIC PAIN EVALUATION', 'timeFrame': '3 days before intervention', 'description': 'DN4 Test ( for neuropathic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neuropathic pain. It consist in several questions to evaluate the clinical situation and some others about the physical situation.'}], 'secondaryOutcomes': [{'measure': 'INMEDIATELY POSTOPERATIVE PAIN EVALUATION', 'timeFrame': '3 days after intervention', 'description': 'Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10'}, {'measure': 'INMEDIATELY POSTOPERATIVE PAIN EVALUATION', 'timeFrame': '3 days after intervention', 'description': 'DN4 Test ( for neuropathic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neuropathic pain. It consist in several questions to evaluate the clinical situation and some others about the physical situation.'}, {'measure': '1 MONTH POSTOPERATIVE PAIN EVALUATION', 'timeFrame': '1 MONTH', 'description': 'Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10'}, {'measure': '1 MONTH POSTOPERATIVE PAIN EVALUATION', 'timeFrame': '1 MONTH', 'description': 'DN4 Test ( for neuropathic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neuropathic pain. It consist in several questions to evaluate the clinical situation and some others about the physical situation.'}, {'measure': '1 MONTH POSTOPERATIVE HEALTH EVALUATION', 'timeFrame': '1 MONTH', 'description': 'Test SF-12 about health situation. This is the recommended test of the Spanish Pain society for subjective evaluation of health situations. It consist in 12 questions about its own perceptions, employment status, daily activities, frame of mind'}, {'measure': '1 MONTH POSTOPERATIVE SLEEP EVALUATION', 'timeFrame': '1 MONTH', 'description': 'Test MOS (Sleep Scale from the Medical Outcomes Study) Some questions for sleep evaluation'}, {'measure': '3 MONTH POSTOPERATIVE PAIN EVALUATION', 'timeFrame': '3 MONTH', 'description': 'Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10'}, {'measure': '3 MONTH POSTOPERATIVE PAIN EVALUATION', 'timeFrame': '3 MONTH', 'description': 'DN4 Test ( for neuropathic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neuropathic pain. It consist in several questions to evaluate the clinical situation and some others about the physical situation.'}, {'measure': '3 MONTH POSTOPERATIVE HEALTH EVALUATION', 'timeFrame': '3 MONTH', 'description': 'Test SF-12 about health situation. This is the recommended test of the Spanish Pain society for subjective evaluation of health situations. It consist in 12 questions about its own perceptions, employment status, daily activities, frame of mind'}, {'measure': '3 MONTH POSTOPERATIVE SLEEP EVALUATION', 'timeFrame': '3 MONTH', 'description': 'Test MOS (Sleep Scale from the Medical Outcomes Study) Some questions for sleep evaluation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['transcutaneous electrical nerve stimulation'], 'conditions': ['Phantom Limb Pain', 'Peripheral Vascular Diseases']}, 'descriptionModule': {'briefSummary': 'A growing body of literature indicates that up to 80% of amputees may have phantom limb pain (PLP). The first cause for limb loss is vascular disease. Usually, amputees who suffer from PLP are suboptimal treated. Therefore, many amputees are disabled by their chronic pain. The etiology and pathophysiology of PLP are poorly understood. Some studies suggest a somatosensory cortex reorganization. Transcutaneous Electrical Nerve Stimulation (TENS) is a analgesic technique. TENS apply a low voltage electrical current through the skin using surface electrodes in order to stimulate afferent nerve fibbers. Because of the lack of evidence to support any treatment for PLP, interest has turned to preventing it instead.\n\nThe aim of this study is to assess if the early use of TENS in the immediately postoperative of major limb amputation due to peripheral vascular disease, should decrease the PLP incidence. TENS should interfere in the mechanism of PLP production to level of the pain fibers conduction.', 'detailedDescription': 'Introduction:\n\nPostamputation pain is highly prevalent after vascular limb amputation. The physiopathological basis should be divided in supraspinal, spinal and peripheral mechanisms. Supraspinal mechanism involve somatosensory cortical reorganization; spinal reorganization in the dorsal horn, occurs after deafferentation from peripheral nerve injury and peripherical nerve injury begins with the nerve section in surgery. All this factors seems to end into a somatosensory cortex reorganization. In this sense, it seems that our ability to prevent PLP depend on the capability to modulate the plasticity of the Central Nervous System (CNS).\n\nTranscutaneous electrical nerve stimulation it´s a safe, easy and inexpensive analgesic technique acting on the conduction pathways of pain. An adequated program is mandatory: balanced symmetrical biphasic pulse, pulse length greater than 250microsg, modulated high frequency and electrodes placed over the dermatomes corresponding to lumbar-sacral spine; will be used in the intervention patients\n\nHypothesis:\n\nIn patients with TENS use during the immediately postoperative of major limb amputation due to peripheral vascular disease, phantom limb pain will appear with less frequency than in control patients.\n\nStudy population:\n\nPatients undergoing major limb amputation for peripheral vascular disease.\n\nStudy design:\n\nA randomized, prospective, blinded (patient, physician, statistician),clinical trial placebo versus intervention group study has been design.\n\nIn the intervention arm, TENS should be applied during the 24 hours immediately after limb amputation. The placebo arm, also will carry TENS but without an active program.\n\nAll patients should receive the standard analgesic treatment for limb amputation during their hospitalization time.\n\nEvaluation and objectives:\n\nBefore surgery all patients made two test for pain evaluation: The Analogical Visual Scale and the DN4 questionnaire for neuropathic pain.\n\nAt 3 days, 1 month and 3 months after surgery, all patients will be evaluated about their pain using the recommended test for neuropathic pain:The Analogical Visual Scale and the DN4 (neuropathic pain 4) questionnaire for neuropathic pain . Also, at month 1 and 3th, two more test should be done in order to evaluate quality of life: The SF-12 (short form-12) health survey questionnaire about health and the Medical Outcomes Study (MOS) for sleep test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years of both genders\n* Critical limb ischemia (arteriopathic or diabetic aetiology)\n* "MINI MENTAL TEST" (minimum 24 points)\n\nExclusion Criteria:\n\n* Pace marker\n* Don´t speak Spanish\n* Not agreement with the study\n* Dermatological lesion affecting the electrode place'}, 'identificationModule': {'nctId': 'NCT02496351', 'briefTitle': 'TENS for Phantom Limb Pain Prevention Following Major Amputation', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}, 'officialTitle': 'Transcutaneous Electrical Nerve Stimulation (TENS) for Phantom Limb Pain Prevention Following Arteriopathic Major Amputation: Clinical Trial', 'orgStudyIdInfo': {'id': '161976BBM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TENS INTERVENTION', 'description': 'In the immediately postoperative of limb amputation, TENS will be use in this patients during 24 hours. The intensity of the impulse will be determined in a test carried out 3 days before surgery. The other parameters will be continuous, biphasic, compensated and symmetric impulse, frequency of 80 Hz, time impulse between 250 and 290 microseconds, modulation time 5´´', 'interventionNames': ['Device: TENS INTERVENTION']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'TENS NO INTERVENTION', 'description': 'In the immediately postoperative of limb amputation, TENS will be use in this patients during 24 hours, but in this case TENS just will be on. No intensity impulse should be programmed.'}], 'interventions': [{'name': 'TENS INTERVENTION', 'type': 'DEVICE', 'description': '24 hours of TENS treatment in the immediately postoperative of limb amputation', 'armGroupLabels': ['TENS INTERVENTION']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12004', 'city': 'Castellon', 'state': 'Castellon de La Plana', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Barbara Bodega, Mrs', 'role': 'CONTACT', 'email': 'barcabo@icloud.com', 'phone': '+34696962685'}, {'name': 'Vanesa Rodenas, Mrs', 'role': 'CONTACT', 'email': 'rodenas_van@gva.es', 'phone': '+34961925963'}], 'facility': 'hospital General Universitario de Castellon', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}], 'centralContacts': [{'name': 'Barbara Bodega, Mrs', 'role': 'CONTACT', 'email': 'barcabo@icloud.com', 'phone': '+34696962685'}, {'name': 'Vanesa Rodenas, Mrs', 'role': 'CONTACT', 'email': 'rodena_van@gva.es', 'phone': '+34961925963'}], 'overallOfficials': [{'name': 'Barbara Bodega, Mrs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General Universitario de Castellon. Avenida Benicassim sn 12004. Castellon. Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Barbara Bodega', 'investigatorAffiliation': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}}}}