NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow

A Randomized Controlled Trial: Alternative Post Procedural Analgesia With NSAIDs vs Opioids in Percutaneous Needle Tenotomy of Elbow

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Elbow Pain
• Intervention / Treatment: Drug: Diclofenac; Drug: Tramadol

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: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jennifer Baldwin; Phone Number: 216.390.5833; Email: baldwij@ccf.org
• Study Contact Backup: Name: Alison Klika, MS; Phone Number: 216 444-4954; Email: klikaa@ccf.org

Study Locations

• United States
  • Florida
    • Coral Springs, Florida, United States, 33067
      • The Cleveland Clinic Florida
      • Contact: Alison Klika; Phone Number: 216 444-4954; Email: klikaa@ccf.org
      • Contact: Jennifer Baldwin; Phone Number: 216-390-5833; Email: baldwij3@ccf.org
      • Principal Investigator: Michael Dakkak, DO
  • Ohio
    • Avon, Ohio, United States, 44011
      • The Cleveland Clinic Ohio
      • Contact: Jennifer Baldwin; Phone Number: 216-390-5833; Email: baldwij3@ccf.org
      • Sub-Investigator: Jason Genin, DO
      • Sub-Investigator: Vikas Patel, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diclofenac; 50mg	Drug: Diclofenac; 50mg every 8hours as needed for pain
Active Comparator: Tramadol; 50mg	Drug: Tramadol; 50mg every 8hours as needed for pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pills taken	The number of total Tramadol pills taken per patient between the control (Tramadol + Diclofenac rescue) vs experimental (Diclofenac + Tramadol rescue) groups at two weeks.	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non narcotic use	The percentage of patients randomized to Diclofenac that do not use any narcotic (Tramadol) rescue medication	10 days

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Michael Dakkak, DO, Cleveland Clinic Florida

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Elbow; TenJet
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Diclofenac; Tramadol
• Other Study ID Numbers: 24-307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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