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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
41
A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.
Up to date physical/occupational therapy for lateral epicondylitis
Cleveland Clinic Akron General
Akron, Ohio, United States
Change in Patient Rated Tennis Elbow Evaluation (PRTEE)
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)
Time frame: 12 months
Numeric Pain Rating Scale
change in score from baseline to final 12 month follow up on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain.
Time frame: 12 months
Pain Free Grip Strength
Change in pain free grip strength (kg) on dynamometer from baseline to final PT visit (approximately 12 weeks)
Time frame: at final therapy visit up to 12 weeks after enrollment
Maximum Grip Strength
Change in maximum grip strength (kg) on dynamometer from baseline visit to final PT visit (approximately 12 weeks)
Time frame: at final therapy visit up to 12 weeks after enrollment
Other Treatments Received
We will collect data on whether the patient sought or received treatments beyond physical/occupational therapy over the 12 months of enrollment in the study
Time frame: 12 months
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