Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow

NCT07885280 | Not Yet Recruiting

• 1 other identifier: STUDY26060160
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Tennis elbow is a condition that causes pain on the outside of the elbow, typically caused by motions involving straightening of the arm. The goal of this clinical trial is to investigate whether early surgery leads to better outcomes than physical therapy and watchful waiting for tennis elbow (lateral epicondylitis) in adults. This study aims to answer the following questions:

• Does earlier surgical intervention improve pain and function more than physical therapy and watchful waiting after one year?
• How do symptoms and function compare between the two treatments over two years?
• How often do people who start with physical therapy and watchful waiting end up needing surgery? Researchers will compare early surgery to physical therapy and watchful waiting to see which treatment works better. Participants will...
• be randomly assigned to have surgery or to try physical therapy and watchful waiting.
• have a physical exam and grip strength test at each visit.
• answer questionnaires about their elbow pain and function.
• attend appointments at the start of the study, and at 6 weeks, 3 months, 6 months, 1 year, and 2 years.

Conditions

Lateral Epicondylitis

Keywords

lateral epicondylitis; tennis elbow

Outcome Measures

Primary Outcomes (1)

• Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) from baseline to 1 year

  0 indicates no pain and no disability; 100 indicates worst imaginable pain and significant functional deficit; "change" refers to differences between each timepoint and the baseline, as well as the differences between each consecutive timepoint

  Baseline, 6 weeks, 3 months, 6 months, 1 year

Secondary Outcomes (13)

• Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) at All Other Timepoints

  Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years

• Change in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) at Each Timepoint; "change" refers to differences between each timepoint and the baseline, as well as the differences between each consecutive timepoint

  Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years

• Grip Strength

  Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years

• Conversion Rate

  Baseline to 2 years after baseline

• Patient Satisfaction (5-Point Likert Scale)

  Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years

Study Arms (2)

Surgical

EXPERIMENTAL

Surgical management of lateral epicondylitis

Procedure: Surgical

Conservative

ACTIVE COMPARATOR

Conservative management of lateral epicondylitis with option to convert to surgical management

Procedure: Conservative Arm

Interventions

Conservative Arm PROCEDURE

* Formal physical therapy: eccentric strengthening and stretching program for the wrist extensor musculature, supervised by a licensed physical therapist, for a minimum of 6 weeks * Activity modification counseling: avoidance of repetitive wrist extension, gripping, and forearm rotation activities that reproduce symptoms * Counterforce (lateral epicondyle) bracing during symptomatic activities * NSAIDs or topical anti-inflammatory agents

Conservative

Surgical PROCEDURE

Patients randomized to surgery will undergo operative release and debridement of the common extensor origin within 6 weeks of enrollment. Surgical technique will be at the attending surgeon's discretion and may include open release and debridement of the ECRB, percutaneous release, or arthroscopic release and debridement. Surgical technique will be recorded as a covariate. All surgeries will be performed by fellowship-trained hand and upper extremity surgeons within the Surgery of the Upper Extremity Research (SUPER) Group. Postoperative rehabilitation protocols will follow standard institutional practice and will be recorded.

Surgical

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of lateral epicondylitis, defined by:
• Lateral elbow pain reproduced by resisted wrist extension or resisted middle finger extension
• Tenderness to palpation over the lateral epicondyle or common extensor origin
• Symptom duration of at least 2 weeks and no more than 3 months at time of enrollment
• Willing and able to comply with follow-up schedule and assigned treatment protocol
• Able to provide written informed consent

You may not qualify if:

• Prior surgery on the ipsilateral elbow
• Prior corticosteroid or biologic (PRP, autologous blood) injection to the ipsilateral lateral epicondyle within 3 months of enrollment
• Concomitant ipsilateral elbow pathology (e.g., posterolateral rotatory instability, radial tunnel syndrome, intra-articular pathology, medial epicondylitis)
• Cervical radiculopathy or other proximal source of referred lateral elbow pain
• Active elbow fracture or acute traumatic injury to the affected extremity
• Inflammatory arthropathy affecting the elbow (e.g., rheumatoid arthritis, gout)
• Pregnancy
• Inability to comply with follow-up visits or complete patient-reported outcome instruments
• Concurrent participation in another interventional study affecting upper extremity function

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• John R Fowler, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

• John R Fowler, MD

  University of Pittsburgh Medical Center

  STUDY DIRECTOR

• John R Fowler, MD

  University of Pittsburgh Medical Center

  STUDY CHAIR

Central Study Contacts

John R Fowler, MD

CONTACT

412-605-3245; fowlerjr@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: October 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): September 15, 2030
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)