protocolSection identificationModule nctId: NCT06373978, orgStudyIdInfo id: 24-307, briefTitle: NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The Cleveland Clinic, class: OTHER, descriptionModule briefSummary: This study is a double-blind, randomized controlled trial comparing the effectiveness of oral Diclofenac and Tramadol in reducing the consumption of narcotic pills (primary outcome) and minimizing patients\&#39; exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.The primary objective of this study is to illustrate a reduction in the consumption of narcotic pills following a percutaneous needle tenotomy procedure on the lateral elbow.The secondary aim is to assess the proportion of patients who have been randomly assigned to Diclofenac and successfully refrain from using the Tramadol rescue medication, measured at the 10 day (+/- 4 days) postoperative mark.The third objective is to uphold consistent early recovery outcomes as measured by the Patient-Rated Tennis Elbow Evaluation (PRTEE) and Quick Disability of Arm, Shoulder, and Hand (QuickDASH) scores after percutaneous needle tenotomy of the lateral elbow, while also investigating the relationship between resiliency and pain catastrophizing in relation to Tramadol usage and response to Diclofenac., conditionsModule conditions: Elbow Pain, conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study will be a double-blind, randomized trial comparing a control group receiving the standard care narcotic Tramadol (50mg) to an experimental group receiving Diclofenac (50mg)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: Diclofenac, interventions name: Tramadol, outcomesModule primaryOutcomes measure: Number of pills taken, secondaryOutcomes measure: Non narcotic use, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Cleveland Clinic Florida, city: Coral Springs, state: Florida, zip: 33067, country: United States, contacts name: Jennifer Baldwin, role: CONTACT, phone: 216-390-5833, email: baldwij3@ccf.org, contacts name: Alison Klika, role: CONTACT, phone: 216 444-4954, email: klikaa@ccf.org, contacts name: Michael Dakkak, DO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.27119, lon: -80.2706, locations facility: The Cleveland Clinic Ohio, city: Avon, state: Ohio, zip: 44011, country: United States, contacts name: Jennifer Baldwin, role: CONTACT, phone: 216-390-5833, email: baldwij3@ccf.org, contacts name: Jason Genin, DO, role: SUB_INVESTIGATOR, contacts name: Vikas Patel, DO, role: SUB_INVESTIGATOR, geoPoint lat: 41.45171, lon: -82.03542, hasResults: False