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NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow

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ClinicalTrials.gov Identifier: NCT06373978
Recruitment Status : Not yet recruiting
First Posted : April 18, 2024
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
Michael Dakkak, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE April 1, 2024
First Posted Date  ICMJE April 18, 2024
Last Update Posted Date April 18, 2024
Estimated Study Start Date  ICMJE June 1, 2024
Estimated Primary Completion Date June 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2024)		 Number of pills taken [ Time Frame: 10 days ]
The number of total Tramadol pills taken per patient between the control (Tramadol + Diclofenac rescue) vs experimental (Diclofenac + Tramadol rescue) groups at two weeks.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2024)		 Non narcotic use [ Time Frame: 10 days ]
The percentage of patients randomized to Diclofenac that do not use any narcotic (Tramadol) rescue medication
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow
Official Title  ICMJE A Randomized Controlled Trial: Alternative Post Procedural Analgesia With NSAIDs vs Opioids in Percutaneous Needle Tenotomy of Elbow
Brief Summary

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' 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.
Detailed Description 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). Both medications will be disguised in identical encapsulated pills and distributed in sealed packets. Participants will be advised against taking any other NSAIDs, but may use Tylenol (1000mg every 8 hours) and apply ice or heat as necessary. In case of severe pain following the tenotomy procedure, patients can choose to take either Tramadol (control) or Diclofenac (experimental) orally every 8 hours for the first 72 hours, totaling 9 pills. Additionally, an emergency packet containing 9 pills of Diclofenac (50mg every 8 hours) will be given to the control group, while the experimental group will receive 9 pills of Tramadol (50mg every 8 hours) to be taken as needed for breakthrough pain.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Elbow Pain
  • Chronic Pain
Intervention  ICMJE
  • Drug: Diclofenac
    50mg every 8hours as needed for pain
  • Drug: Tramadol
    50mg every 8hours as needed for pain
Study Arms  ICMJE
  • Active Comparator: Diclofenac
    50mg
    Intervention: Drug: Diclofenac
  • Active Comparator: Tramadol
    50mg
    Intervention: Drug: Tramadol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2024)		 92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2025
Estimated Primary Completion Date June 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18-65 years
  • Percutaneous Needle Tenotomy of Lateral Elbow Procedure
  • Ability to take oral medication and willingness to participate in a 2-week follow-up pill counts
  • Musculoskeletal ultrasound or MRI with diagnosis of tendinosis of the common extensor tendon of the elbow

Exclusion Criteria:

  • • Any full thickness common extensor tendon tear of the elbow

    • Prior history of elbow surgery
    • Symptomatic cervical radiculopathy
    • Concurrent symptoms of the medial elbow
    • Treatment with another investigational drug or other intervention concurrently or previously that would interfere with postoperative pain control
    • Psychiatric illness that impedes evaluation of pain and/or narcotics use
    • No history of inflammatory arthritis, diabetes, chronic regional pain syndrome, connective tissue disease, fibromyalgia or autoimmune disease
    • No contraindications to NSAIDs or Opioids
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Baldwin 216.390.5833 baldwij@ccf.org
Contact: Alison Klika, MS 216 444-4954 klikaa@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06373978
Other Study ID Numbers  ICMJE 24-307
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Michael Dakkak, The Cleveland Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The Cleveland Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Dakkak, DO Cleveland Clinic Florida
PRS Account The Cleveland Clinic
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP