Recruiting

Acetaminophen, Diclofenac, Tramadol

Sponsor:

The Cleveland Clinic

Code:

NCT06373978

Conditions

Elbow Pain

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Diclofenac

Tramadol

Acetaminophen

Study Details

Brief summary:

This study is a double-blind, randomized controlled trial comparing the effectiveness of oral acetaminophen, diclofenac, and tramadol in reducing the consumption of narcotic doses (primary outcome) and minimizing patients' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.

Conditions

Elbow Pain

Chronic Pain

Study ID

NCT06373978

Start date

Aug 12, 2024

Status verified date

Feb, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Diclofenac

50mg

active comparator: Tramadol

50mg

sham comparator: Acetaminophen

1000mg

Interventions

Diclofenac

50mg every 8hours as needed for pain

Tramadol

50mg every 8hours as needed for pain

Acetaminophen

1000mg every 8hours as needed for pain

Primary outcome measure

  • Number of pills taken [ Time Frame: 10 days ]

Central Contacts and Locations

Central contacts

Erin Clancy, BA

2169706796clancye@ccf.org

Jennifer Baldwin

216-390-5833baldwij3@ccf.org

Locations

The Cleveland Clinic Florida

Recruiting

Coral Springs, Florida, United States, 33067

Contacts

Erin Clancy, BA

216.970.6796clancye@ccf.org

Jennifer Baldwin

216.390.5833baldwij3@ccf.org

Principal Investigator:

Michael Dakkak, DO

The Cleveland Clinic Ohio

Recruiting

Avon, Ohio, United States, 44011

Contacts

Jennifer Baldwin

216.390.5833baldwij3@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Aug 28, 2026

Last verified

Feb, 2026

Keywords

  • TenJet
  • Elbow

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-08-28.