Comparison of Intra-articular and Intra-tendinous Injections for Treatment of Lateral Epicondylitis

NCT02986646 | Terminated

• 2 other identifiers: 16-28017-022
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Lateral epicondylitis, commonly known as "tennis elbow" is a common cause of elbow pain encountered in primary care and specialty clinics. Although lateral epicondylitis is common, little consensus exists on the best way to treat it. Historically 80% of patients will get better with non-operative treatments (rest, NSAIDS, bracing and injections). In regard to efficacy of injections, recent large, prospective, randomized studies have shown minor improvements in the short term, but no long term benefits when compared to saline injection. Consistently, intra-articular injections have not been reported. The investigators suspect that elbow joint inflammation may be an underappreciated source of pain in lateral epicondylitis. The investigators' hypothesis is that patients receiving intra-articular injections will have greater improvement compared to patients receiving either no injection or an intra-tendinous injection.

Conditions

Lateral Epicondylitis

Outcome Measures

Primary Outcomes (1)

• PRTEE (Patient Rated Tennis Elbow Evaluation)

  The primary analysis will compare the PRTEE scores of each group at 2 years post-enrollment.

  2 years

Study Arms (3)

physical therapy (PT) and rest

This group of subjects will be prescribed a physical therapy home exercise program and rest (of the injured elbow).

PT and intra-tendinous steroid injection

This group of subjects will be prescribed a physical therapy home exercise program and will received an intra-tendinous corticosteroid injection into the area of the ECRB origin (of the injured elbow).

PT and intra-articular steroid injection

This group of subjects will be prescribed a physical therapy home exercise program and will received an intra-articular corticosteroid injection into the elbow joint (of the injured elbow).

Eligibility Criteria

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

Study Population

Patients who are seeking care from either a primary care sports medicine physician or orthopaedic surgeon for their persistent and limiting elbow pain.

You may qualify if:

• Confirmed diagnosis of lateral epicondylitis based on 2 or more of the following diagnostic criteria: tenderness over the lateral epicondyle; pain with resisted wrist extension; pain with resisted long finger extension.
• Symptoms lasting a minimum of 6 weeks
• Pain score of \>= 3/10 using the Visual Analog Scale (VAS)
• Age \>= 18 years

You may not qualify if:

• History of prior elbow surgery
• History elbow fracture within the past year
• Elbow instability on physical examination
• Elbow arthritis on radiographs
• Compressive neuropathy in the affected extremity (i.e.carpal tunnel, cubital tunnel)
• Evidence of cervical myelopathy, radiculopathy or brachial plexopathy
• History of systemic inflammatory condition (i.e. rheumatoid arthritis or systemic lupus erythematosus)
• Allergy to study administered medications (steroid or lidocaine)
• Neoplasm
• Non-English speaking patients
• Inability to comply with study protocols and follow up.
• Pregnant female

Sponsors & Collaborators

• University of Missouri, Kansas City: lead

Study Sites (1)

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Akin Cil

  University of Missouri Kansas City, Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Franklin D. Dickson Associate Professor, Vice Chairman, Department of Orthopaedic Surgery, Truman Medical Centers

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 8, 2016
• Study Start: January 1, 2017
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)