An interventional study of Conservative Arm and Surgical in Lateral Epicondylitis, sponsored by University of Pittsburgh. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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:
Researchers will compare early surgery to physical therapy and watchful waiting to see which treatment works better.
Participants will...
Lateral epicondylitis (tennis elbow) is a degenerative condition of the common extensor tendon at the lateral epicondyle, most commonly involving the extensor carpi radialis brevis (ECRB). Most cases resolve spontaneously or respond to conservative management within one year, and current standard care reserves surgery for refractory cases after an extended trial of conservative treatment, typically six months or longer. The optimal timing of surgical intervention has not been evaluated in a prospective, randomized trial. This study addresses that gap by enrolling patients with acute-to-subacute symptoms (2 weeks to 3 months in duration) and randomizing them to early surgical intervention versus physical therapy with watchful waiting, followed longitudinally over two years.
This is a prospective, single-center, randomized controlled trial. Eligible, consented participants are randomized 1:1 using a computer-generated block randomization scheme with variable block sizes.
Participants randomized to conservative management receive a structured physical therapy protocol, including a supervised eccentric strengthening and stretching program for the wrist extensors (minimum 6 weeks), activity modification counseling, counterforce bracing, and nonsteroidal anti-inflammatory drugs (NSAIDs) or topical anti-inflammatories as needed. Participants who meet criteria for treatment failure, defined as absence of meaningful clinical improvement or symptom progression as determined by the treating surgeon, are offered conversion to surgery; the timing and reason for conversion are recorded.
Participants randomized to early surgical intervention undergo operative release and debridement of the common extensor origin within 6 weeks of enrollment. Surgical technique (open, percutaneous, or arthroscopic release) is at the attending surgeon's discretion and recorded as a covariate. All surgeries are performed by fellowship-trained hand and upper extremity surgeons.
Participants are followed at baseline, 6 weeks, 3 months, 6 months, 1 year, and 2 years with clinical examination, patient-reported outcome instruments, and (for the surgical arm and conservative-to-surgical crossovers) perioperative and complication data.
The primary analysis will use an intention-to-treat framework, with a per-protocol analysis as a secondary approach. Longitudinal outcomes will be analyzed using mixed-effects linear models accounting for repeated measures within participants, and time to conversion in the conservative arm will be analyzed using Kaplan-Meier methods. As a secondary aim, the study will derive a minimal clinically important difference (MCID) for the Patient-Rated Tennis Elbow Evaluation (PRTEE) in this population, using both anchor-based (patient satisfaction and Global Rating of Change as external anchors, with receiver operating characteristic (ROC) curve analysis) and distribution-based methods.
296 studies on the registry are indexed under Tennis Elbow; 63 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 263 interventional studies indexed under Tennis Elbow.
Browse Tennis Elbow studies →University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Clinical diagnosis of lateral epicondylitis, defined by:
Exclusion Criteria:
Surgical management of lateral epicondylitis
Procedure: Surgical
Conservative management of lateral epicondylitis with option to convert to surgical management
Procedure: Conservative Arm
* 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
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.
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
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) at All Other Timepoints
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
Time frame: 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
0 indicates no disability; 100 indicates the most severe disability; "change" refers to differences between each timepoint and the baseline, as well as the differences between each consecutive timepoint
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Grip Strength
Change in grip strength (in pounds and kilograms) at 90 degrees of elbow flexion, and at full elbow flexion; "change" refers to differences between each timepoint and the baseline, as well as the differences between each consecutive timepoint
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Conversion Rate
Rate of conversion to surgery (as a percentage)
Time frame: Baseline to 2 years after baseline
Patient Satisfaction (5-Point Likert Scale)
Participant-reported satisfaction with treatment outcome using a 5-point Likert scale (minimum 1; maximum 5; higher score indicates greater satisfaction)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Global Rating of Change
Participant-reported overall change in symptoms and function (minimum -3 indicating much worse; maximum +3 indicating much better)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Return to Work/Activities (Self-Reported Work Status)
Time, in days, from enrollment (or from surgery, for the surgical arm and crossovers) to return to work, based on participant self-reported work status (working, modified duty, or off work due to symptoms), and to participant-reported return to full activity or sport.
Time frame: Baseline to 2 years after baseline
Complication Rates
Time frame: 1 year post-op
Reoperation Rate
Time frame: 1 year post-op
Meaningful Threshold for Patient-Rated Tennis Elbow Evaluation (PRTEE) Using Change in Patient-Reported Satisfaction as an Anchor
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
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Cozen's Test
Positive or negative tenderness with resisted dorsiflexion of the wrist
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Mill's Test
Positive or negative tenderness with elbow extension while the forearm is pronated and the wrist is flexed
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Maudsley's Test
Positive or negative tenderness with resisted extension of the middle finger
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Plan to share: No — Individual participant data will not be shared with outside researchers to preserve participant privacy and confidentiality.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Sep 2028, 23 months later.
Of 147 non-industry interventional studies with no phase under Tennis Elbow, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 23 months is above that.
Counting every sponsor, half of 150 studies reached it within 9 months; a quarter within 5 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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