Lateral Epicondylitis
Conditions
Keywords
lateral epicondylitis, tennis elbow
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.
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.
Interventions
PROCEDUREConservative 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
PROCEDURESurgical
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.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) from baseline to 1 year | Baseline, 6 weeks, 3 months, 6 months, 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) at All Other Timepoints | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | 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 |
| 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 | 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 |
| Grip Strength | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | 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 |
| Conversion Rate | Baseline to 2 years after baseline | Rate of conversion to surgery (as a percentage) |
| Patient Satisfaction (5-Point Likert Scale) | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | Participant-reported satisfaction with treatment outcome using a 5-point Likert scale (minimum 1; maximum 5; higher score indicates greater satisfaction) |
| Global Rating of Change | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | Participant-reported overall change in symptoms and function (minimum -3 indicating much worse; maximum +3 indicating much better) |
| Return to Work/Activities (Self-Reported Work Status) | Baseline to 2 years after baseline | 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. |
| Complication Rates | 1 year post-op | — |
| Reoperation Rate | 1 year post-op | — |
| Meaningful Threshold for Patient-Rated Tennis Elbow Evaluation (PRTEE) Using Change in Patient-Reported Satisfaction as an Anchor | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | 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 |
| Cozen's Test | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | Positive or negative tenderness with resisted dorsiflexion of the wrist |
| Mill's Test | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | Positive or negative tenderness with elbow extension while the forearm is pronated and the wrist is flexed |
| Maudsley's Test | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | Positive or negative tenderness with resisted extension of the middle finger |
Countries
United States
Contacts
CONTACTJohn R Fowler, MD
PRINCIPAL_INVESTIGATORJohn R Fowler, MD
University of Pittsburgh Medical Center
STUDY_DIRECTORJohn R Fowler, MD
University of Pittsburgh Medical Center
STUDY_CHAIRJohn R Fowler, MD
University of Pittsburgh Medical Center
Outcome results
None listed