Trial of Blood Flow Restriction Plus Physical Therapy vs. Physical Therapy Alone for Lateral Epicondylitis
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|ClinicalTrials.gov Identifier: NCT03978897|
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : January 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lateral Epicondylitis||Device: Blood flow restriction tourniquet Other: Evidence based physical/occupational therapy||Not Applicable|
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. 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 (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Official Title:||A Randomized Controlled Trial of Blood Flow Restriction Plus Conventional Physical Therapy vs. Conventional Physical Therapy Alone in the Treatment of Lateral Epicondylitis|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||July 1, 2023|
Experimental: 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).
Device: Blood flow restriction tourniquet
A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.
Other Name: Delfi personalized tourniquet system
Active Comparator: 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
Other: Evidence based physical/occupational therapy
Up to date physical/occupational therapy for lateral epicondylitis
- Patient rated tennis elbow evaluation (PRTEE) [ Time Frame: 12 months ]
Change in score on 'Patient rated tennis elbow evaluation' total score. 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)
- Numeric pain rating scale [ Time Frame: 12 months ]change in score on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain.
- Pain free grip strength [ Time Frame: at final therapy visit up to 12 weeks after enrollment ]Change in pain free grip strength on dynamometer
- Maximum grip strength [ Time Frame: at final therapy visit up to 12 weeks after enrollment ]Change in maximum grip strength on dynamometer
- Other treatments received [ Time Frame: 12 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978897
|Contact: Chanda Mullen, PhDfirstname.lastname@example.org|
|Contact: Aaron Lear, MD, CAQ||3303446047||LearA@ccf.org|
|United States, Ohio|
|Cleveland Clinic Akron General||Recruiting|
|Akron, Ohio, United States, 44307|
|Contact: Philip Toal, DPT 330-344-6000 email@example.com|
|Principal Investigator:||Aaron Lear, MD, CAQ||Cleveland Clinic Akron General|