Lateral EpicondylitisNCT07885280
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
A study testing Conservative Arm and Surgical in people with Lateral Epicondylitis, run by University of Pittsburgh at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Conservative Arm and Surgical
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to 15 Sep 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Pregnancy
- Inability to comply with follow-up visits or complete patient-reported outcome instruments
- Concurrent participation in another interventional study affecting upper extremity function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UPMC
Pittsburgh, Pennsylvania, 15213
Michael P Chen, MD, 4258919823, chenmp@upmc.edu
About this study
Official title: Nonoperative vs. Surgical Release for Acute-to-Subacute Lateral Epicondylitis: A Prospective Randomized Controlled Trial
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Lateral Epicondylitis
- Being tested
- Conservative Arm, Surgical
- Keywords
- lateral epicondylitis, tennis elbow
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative ArmProcedure or surgery
- 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
SurgicalProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Experimental | Surgical management of lateral epicondylitis Receives: Procedure: Surgical |
| Conservative | Active comparator | Conservative management of lateral epicondylitis with option to convert to surgical management Receives: Procedure: Conservative Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year
Secondary outcomes (13)
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
Measured: 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
Measured: 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
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Conversion Rate
Rate of conversion to surgery (as a percentage)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: Baseline to 2 years after baseline
Complication Rates
Measured: 1 year post-op
Reoperation Rate
Measured: 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
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Cozen's Test
Positive or negative tenderness with resisted dorsiflexion of the wrist
Measured: 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
Measured: 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
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startOct 2026 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Fowler, University of Pittsburgh
- Investigators
- John R Fowler, MD, Principal investigator, University of Pittsburgh Medical CenterJohn R Fowler, MD, Study director, University of Pittsburgh Medical CenterJohn R Fowler, MD, Study chair, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885280
- Sponsor's protocol ID
- STUDY26060160
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with outside researchers to preserve participant privacy and confidentiality.