A Randomized Controlled Trial of Blood Flow Restriction Plus Conventional Physical Therapy vs. Conventional Physical Therapy Alone in the Treatment of Lateral Epicondylitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Change in Patient Rated Tennis Elbow Evaluation (PRTEE)
Study Overview
Brief Summary
Open label randomized controlled trial comparing evidenced based physical/occupational therapy vs. physical/occupational therapy including blood flow restriction tourniquet in the treatment of lateral epicondylitis (tennis elbow).
Detailed Description
Patients will be randomized to one of two groups, and treatment will be open label and unblinded. A target of 44 patients for enrollment has been set for 80% power, actual enrollment resulted in 41 patients undergoing randomization. Treatment will last for 6 visits with physical therapy with recommended visit intervals of 1 week :
Intervention Group: Evidence based physical/occupational therapy, with the addition of therapeutic exercises using a blood flow restriction tourniquet.
Control Group: Patients will receive standard evidence based physical therapy
The primary outcome (Patient-Rated Tennis Elbow Evaluation [PRTEE]) will be collected at enrollment, 3, 6, and 12 months.
Secondary outcomes will be collected at the beginning and end of physical therapy interventions (change in: numeric pain rating scale, maximum pain free grip strength, pain free grip strength). We will collect treatments received after the end of physical therapy and before final follow up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Treating therapists and patient will be aware of treatment. The outcome assessor will have access to outcome data only, without knowledge of which treatment patient received.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The diagnoses included are lateral elbow pain, lateral epicondylitis, or lateral epicondylalgia, more general diagnoses elbow tendinitis or elbow pain will be included if their clinical picture at physical therapy meets criteria for lateral epicondylitis.
- •If the inclusion diagnosis is other than lateral epicondylitis or tennis elbow (such as elbow pain), we will confirm the diagnosis at the first therapy visit with tenderness at the lateral epicondyle and/or pain with resisted wrist/long finger extension at the lateral epicondyle.
- •Pain for 4 weeks or more.
- •All participants must be between the age of 18 and 70 years old and have had pain for 4 weeks or more.
Exclusion Criteria
- •Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the affected limb will be excluded from the study.
- •Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow,
- •Vascular disorders to include: history of DVT, history of endothelial dysfunction, peripheral vascular disease
- •Injection therapy (corticosteroid, platelet rich plasma, or other injection therapy) in the prior 3 months to the affected site
- •Current fracture in affected arm
- •History of crush injury to affected arm
- •Any surgery on affected arm in last 1 year
- •Surgical procedure on their contralateral extremity (Changed 9/2019 to surgery within last year on contralateral upper extremity).
- •History of lymphectomy (such as axillary exploration with breast surgery, lymph node biopsy in the affected axilla/arm)
- •Pregnancy
- •Active infection
- •Current cancer diagnosis/treatment
- •Sickle cell anemia or trait
- •Kidney dialysis
- •History of syncope/passing out with pressure to body (such as massage, or blood pressure cuff).
- •inability to consent
Arms & Interventions
Blood flow restriction with physical/occupational therapy
physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period).
Intervention: Blood flow restriction tourniquet (Device)
Evidence based physical/occupational therapy
evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet
Intervention: Evidence based physical/occupational therapy (Other)
Outcomes
Primary Outcomes
Change in Patient Rated Tennis Elbow Evaluation (PRTEE)
Time Frame: 12 months
Change in score on 'Patient rated tennis elbow evaluation' total score from baseline to 12 month final follow up. Lower numbers suggest less pain, higher scores suggest more pain. Total score 0-100. Includes pain subscale (0-50) Specific activities subscale (0-60) Usual activities subscale (0-40) Function Subscale= (specific activities score + usual activities score)/2 (0-50) Total Score= Pain subscale + Function Subscale (0-100)
Secondary Outcomes
- Numeric Pain Rating Scale(12 months)
- Pain Free Grip Strength(at final therapy visit up to 12 weeks after enrollment)
- Maximum Grip Strength(at final therapy visit up to 12 weeks after enrollment)
- Other Treatments Received(12 months)
Investigators
Aaron Lear
Director of Primary Care Sports Medicine
Cleveland Clinic Akron General