Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT03415204
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2018-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'average post operative pain during time of hospitalization', 'timeFrame': 'average pain score during 5 days following operation', 'description': 'post operative pain will measured twice daily - morning and afternoon during hospitalization time. patients will be asked to rate thier pain on a visual analog scale ranging from 0- no pain to 10 - severe pain'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthroplasty Complications']}, 'referencesModule': {'references': [{'pmid': '37920858', 'type': 'DERIVED', 'citation': 'Rubin L, Avraham Y, Sharabi-Nov A, Shebly T, Ben Natan M, Rothem DE. Acupuncture Effect on Analgesic Consumption and Cortisol Levels Following Total Knee Arthroplasty: A Randomized Controlled Trial. Med Acupunct. 2023 Oct 1;35(5):230-235. doi: 10.1089/acu.2023.0024. Epub 2023 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'Post operative pain (POP) is a major obstacle on the road to healing, despite the increasing interest in postoperative pain management and development of pain control modalities (1). Postoperative pain is still insufficiently treated with more than 50% of patients suffering from moderate to severe pain early after surgery .Pain after orthopedic surgery is considered especially difficult to manage. Approximately half of total knee or hip arthroplasty patients present with extreme pain immediately after surgery. Total knee and hip arthroplasty often results not only in severe perioperative pain and debilitation, but chronic pain, joint stiffness, and functional disability many months or even years following the procedure. Various modalities of treating orthopedic POP exist, but the optimal management of postoperative pain remains controversial with no clear consensus of the best method.We suggest that acupuncture can be an effective treatment for post operative pain after total knee or hip arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent, above 18 years of age, about to undergo total knee or hip arthroplasty\n\nExclusion Criteria:\n\n* Known mental disease, active cancer disease, coagulopathy, Hepatitis B,C.'}, 'identificationModule': {'nctId': 'NCT03415204', 'briefTitle': 'Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ziv Hospital'}, 'officialTitle': 'Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty', 'orgStudyIdInfo': {'id': '0104-17-ZIV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acupuncture', 'interventionNames': ['Other: acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'no acupuncture'}], 'interventions': [{'name': 'acupuncture', 'type': 'OTHER', 'description': 'acupuncture for post operative pain', 'armGroupLabels': ['acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Safed', 'country': 'Israel', 'facility': 'Ziv Medical Center', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}