Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-27 @ 9:55 PM
Study NCT ID:
NCT00460161
Status:
SUSPENDED
Last Update Posted:
2009-02-18
First Post:
2007-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture for Phantom Limb Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010591', 'term': 'Phantom Limb'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'whyStopped': 'Lack of patients', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'lastUpdateSubmitDate': '2009-02-17', 'studyFirstSubmitDate': '2007-04-12', 'studyFirstSubmitQcDate': '2007-04-12', 'lastUpdatePostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'To study the effect of acupuncture on phantom limb pain at 3 months post-amputation', 'timeFrame': '3 months'}, {'measure': 'To study the effect of acupuncture on stump pain at 4 weeks post-amputation', 'timeFrame': '4 weeks'}, {'measure': 'To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation', 'timeFrame': '4 weeks'}, {'measure': 'To study the effect of acupuncture on parameters of depression (using the Beck Depression Score) at 4 weeks and 3 months post-amputation', 'timeFrame': '4 weeks and 3 months'}, {'measure': 'To study the safety of acupuncture treatment in patients following amputation with phantom limb pain', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acupuncture', 'amputation', 'phantom limb pain'], 'conditions': ['Phantom Limb Pain']}, 'descriptionModule': {'briefSummary': 'Phantom pain is a common complication following limb amputation, and is thought to result from a system of pathophysiological mechanisms - peripheral, spinal, central and psychological. Treatment is primarily medical, using antidepressant and anticonvulsant medications. At present, there is no evidence-based approach for the management of phantom limb pain (PLP). Acupuncture is an ancient Chinese treatment during which thin needles (diameter 0.20-0.30mm) are inserted into various points on the skin. Studies of this treatment have found significant benefit in a number of conditions with chronic pain.\n\nWe propose a randomized, double-blind, placebo/sham -controlled study to evaluate whether acupuncture is an effective and safe modality for preventing and reducing PLP in patients following lower limb amputation. Patients requiring lower limb amputation (above-ankle) will be randomized into two groups, for real or placebo/sham acupuncture treatment. Both groups will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment protocol, using either true or placebo needles at sham acupuncture points, for a period of four weeks (eight treatments).\n\nThe primary outcome to be evaluated will be PLP at 4 weeks, using a site-specific numerical rating pain scale (ss-NRS). Secondary outcome measures to be evaluated are: stump pain (ss-NRS); analgesic use (Tramadol, 100mg Tablet); and depressive symptoms, using the Beck Depression Score. Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of either gender\n* Age 18 years and older\n* Scheduled for lower single limb amputation (above or below knee)\n* Ability to comply with study protocol\n\nExclusion Criteria:\n\n* Patients requiring limb amputation due to trauma\n* Patients displaying symptoms of overt Axis-1 psychopathology such as Schizophrenia or Substance Abuse\n* Inability to comply with the study protocol\n* Previous experience with acupuncture treatment; current use of complementary or alternative medical treatments.'}, 'identificationModule': {'nctId': 'NCT00460161', 'briefTitle': 'Acupuncture for Phantom Limb Pain', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'Acupuncture for Phantom Limb Pain: A Randomized, Double-Blind, Placebo/Sham - Controlled Study', 'orgStudyIdInfo': {'id': 'ACP.PLP.10.06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'true acupuncture', 'interventionNames': ['Procedure: acupuncture']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo/sham acupuncture', 'interventionNames': ['Other: placebo/sham acupuncture']}], 'interventions': [{'name': 'acupuncture', 'type': 'PROCEDURE', 'description': '2 treatments/week for 4 weeks', 'armGroupLabels': ['1']}, {'name': 'placebo/sham acupuncture', 'type': 'OTHER', 'description': '2 treatments/week for 4 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91031', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Noah Samuels, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaare Zedek Medical Center, Jerusalem, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Noah Samuels', 'oldOrganization': 'Shaare Zedek Medical Center'}}}}