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出境医 / 临床实验 / Trial of Blood Flow Restriction Plus Physical Therapy vs. Physical Therapy Alone for Lateral Epicondylitis
Trial of Blood Flow Restriction Plus Physical Therapy vs. Physical Therapy Alone for Lateral Epicondylitis
Study Description
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lateral Epicondylitis | Device: Blood flow restriction tourniquet Other: Evidence based physical/occupational therapy | Not Applicable |
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 Design
| 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 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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)
Secondary Outcome Measures :
- 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
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Contacts
| Contact: Chanda Mullen, PhD | 3303446236 | mullenc@ccf.org | |
| Contact: Aaron Lear, MD, CAQ | 3303446047 | LearA@ccf.org |
Locations
| United States, Ohio | |
| Cleveland Clinic Akron General | Recruiting |
| Akron, Ohio, United States, 44307 | |
| Contact: Philip Toal, DPT 330-344-6000 toalp2@ccf.org | |
Sponsors and Collaborators
Akron General Medical Center
Investigators
| 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)
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| 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. |
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| 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 | ||||||||
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* 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 |
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| 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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