NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow

NCT06373978 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 24-307
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

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

Keywords

TenJet; Elbow

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Non narcotic use

  10 days

Study Arms (3)

Diclofenac

ACTIVE COMPARATOR

50mg

Drug: Diclofenac; Other: Acetaminophen

Tramadol

ACTIVE COMPARATOR

50mg

Drug: Tramadol; Other: Acetaminophen

Acetaminophen

SHAM COMPARATOR

1000mg

Other: Acetaminophen

Interventions

Diclofenac DRUG

50mg every 8hours as needed for pain

Diclofenac

Tramadol DRUG

50mg every 8hours as needed for pain

Tramadol

Acetaminophen OTHER

1000mg every 8hours as needed for pain

Acetaminophen; Diclofenac; Tramadol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (2)

The Cleveland Clinic Florida

Coral Springs, Florida, 33067, United States

RECRUITING

The Cleveland Clinic Ohio

Avon, Ohio, 44011, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Diclofenac; Tramadol; Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds

Study Officials

• Michael Dakkak, DO

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Clancy, BA

CONTACT

2169706796; clancye@ccf.org

Jennifer Baldwin

CONTACT

216-390-5833; baldwij3@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study PI

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 18, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)