| 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 |
| Allocation: | Randomized |
| 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. |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
|
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
|
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)
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Chanda Mullen, PhD | 3303446236 | mullenc@ccf.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 toalp2@ccf.org | |
| Principal Investigator: | Aaron Lear, MD, CAQ | Cleveland Clinic Akron General |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 24, 2019 | ||||||||
| First Posted Date ICMJE | June 7, 2019 | ||||||||
| Last Update Posted Date | January 15, 2021 | ||||||||
| Actual Study Start Date ICMJE | July 1, 2019 | ||||||||
| Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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)
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Trial of Blood Flow Restriction Plus Physical Therapy vs. Physical Therapy Alone for Lateral Epicondylitis | ||||||||
| Official Title ICMJE | A Randomized Controlled Trial of Blood Flow Restriction Plus Conventional Physical Therapy vs. Conventional Physical Therapy Alone in the Treatment of Lateral Epicondylitis | ||||||||
| 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. 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 ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized 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. Primary Purpose: Treatment
|
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| Condition ICMJE | Lateral Epicondylitis | ||||||||
| Intervention ICMJE |
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
44 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 1, 2023 | ||||||||
| Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03978897 | ||||||||
| Other Study ID Numbers ICMJE | 19001 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Aaron Lear, Akron General Medical Center | ||||||||
| Study Sponsor ICMJE | Akron General Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Akron General Medical Center | ||||||||
| Verification Date | January 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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