Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood flow restriction with physical/occupational therapy | Experimental | physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period). |
|
| Evidence based physical/occupational therapy | Active Comparator | evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood flow restriction tourniquet | Device | A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Pain Free Grip Strength |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aaron Lear, MD, CAQ | Cleveland Clinic Akron General | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Akron General | Akron | Ohio | 44307 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). Blood flow restriction tourniquet: A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow. |
| FG001 | 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 Evidence based physical/occupational therapy: Up to date physical/occupational therapy for lateral epicondylitis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). Blood flow restriction tourniquet: A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
0-12 weeks of physical therapy
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). Blood flow restriction tourniquet: A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Lear | Cleveland Clinic | 330.344.6047 | leara@ccf.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2026 | Mar 20, 2026 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
|
| Evidence based physical/occupational therapy | Other | Up to date physical/occupational therapy for lateral epicondylitis |
|
Change in pain free grip strength (kg) on dynamometer from baseline to final PT visit (approximately 12 weeks)
| 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) | 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 | 12 months |
| 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 Evidence based physical/occupational therapy: Up to date physical/occupational therapy for lateral epicondylitis |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 Evidence based physical/occupational therapy: Up to date physical/occupational therapy for lateral epicondylitis |
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | 0-10 self assessment pain scale | 12 months |
|
|
|
| Secondary | Pain Free Grip Strength | Change in pain free grip strength (kg) on dynamometer from baseline to final PT visit (approximately 12 weeks) | Posted | Mean | 95% Confidence Interval | kg | at final therapy visit up to 12 weeks after enrollment |
|
|
|
| Secondary | Maximum Grip Strength | Change in maximum grip strength (kg) on dynamometer from baseline visit to final PT visit (approximately 12 weeks) | Posted | Dec 2026 | Mean | 95% Confidence Interval | kg | at final therapy visit up to 12 weeks after enrollment |
|
|
|
| Secondary | 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 | Posted | Number | Number of patients receiving other treat | 12 months |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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 Evidence based physical/occupational therapy: Up to date physical/occupational therapy for lateral epicondylitis | 0 | 22 | 0 | 22 | 0 | 22 |
Not provided
Not provided
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D013812 |
| Therapeutics |