Trial of Blood Flow Restriction Plus Physical Therapy vs. Physical Therapy Alone for Lateral Epicondylitis
- Conditions
- Lateral Epicondylitis
- Registration Number
- NCT03978897
- Lead Sponsor
- Cleveland Clinic Akron General
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria:<br><br> - The diagnoses included are lateral elbow pain, lateral epicondylitis, or lateral<br> epicondylalgia, more general diagnoses elbow tendinitis or elbow pain will be<br> included if their clinical picture at physical therapy meets criteria for lateral<br> epicondylitis.<br><br> - If the inclusion diagnosis is other than lateral epicondylitis or tennis elbow (such<br> as elbow pain), we will confirm the diagnosis at the first therapy visit with<br> tenderness at the lateral epicondyle and/or pain with resisted wrist/long finger<br> extension at the lateral epicondyle.<br><br> - Pain for 4 weeks or more.<br><br> - All participants must be between the age of 18 and 70 years old and have had pain<br> for 4 weeks or more.<br><br>Exclusion Criteria:<br><br> - Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the<br> affected limb will be excluded from the study.<br><br> - Any history of ligamentous, bony or other soft tissue reconstruction surgery at the<br> affected elbow,<br><br> - Vascular disorders to include: history of DVT, history of endothelial dysfunction,<br> peripheral vascular disease<br><br> - Injection therapy (corticosteroid, platelet rich plasma, or other injection therapy)<br> in the prior 3 months to the affected site<br><br> - Current fracture in affected arm<br><br> - History of crush injury to affected arm<br><br> - Any surgery on affected arm in last 1 year<br><br> - Surgical procedure on their contralateral extremity (Changed 9/2019 to surgery<br> within last year on contralateral upper extremity).<br><br> - History of lymphectomy (such as axillary exploration with breast surgery, lymph node<br> biopsy in the affected axilla/arm)<br><br> - Pregnancy<br><br> - Active infection<br><br> - Current cancer diagnosis/treatment<br><br> - Sickle cell anemia or trait<br><br> - Kidney dialysis<br><br> - History of syncope/passing out with pressure to body (such as massage, or blood<br> pressure cuff).<br><br> - inability to consent
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient rated tennis elbow evaluation (PRTEE)
- Secondary Outcome Measures
Name Time Method Numeric pain rating scale;Pain free grip strength;Maximum grip strength;Other treatments received