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The goal of this investigation is to determine if using BFR during postoperative therapy would lead to increased and expedited strength gains. Additionally, the investigators would like to determine if BFR is beneficial in preventing muscle atrophy and fatty infiltration in the setting of bicep tendon tears, due to the altered tension-length relationship following surgery. The study will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding distal biceps tear and surgical repair
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BFR | Experimental | Patient will use the following rehabilitation protocol while incorporating blood flow restriction therapy:
|
|
| Control (no BFR) | No Intervention | patients will use following rehabilitation protocol without the use of blood flow restriction therapy:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction Therapy | Other | Use of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Strength | measured via dynamometer (pounds) | 1 week post-operatively |
| Strength | measured via dynamometer (pounds) | 6 weeks post-operatively |
| Strength | measured via dynamometer (pounds) | 3 months post-operatively |
| Strength | measured via dynamometer (pounds) | 6 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion | via goniometer (degrees) | 1 week post-operatively |
| Range of Motion | via goniometer (degrees) | 6 week post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Ford Health System | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18466185 | Background | Wernbom M, Augustsson J, Raastad T. Ischemic strength training: a low-load alternative to heavy resistance exercise? Scand J Med Sci Sports. 2008 Aug;18(4):401-16. doi: 10.1111/j.1600-0838.2008.00788.x. Epub 2008 May 3. | |
| 31592499 | Background | Huynh T, Leiter J, MacDonald PB, Dubberley J, Stranges G, Old J, Marsh J. Outcomes and Complications After Repair of Complete Distal Biceps Tendon Rupture with the Cortical Button Technique. JB JS Open Access. 2019 Aug 27;4(3):e0013.1-6. doi: 10.2106/JBJS.OA.19.00013. eCollection 2019 Jul-Sep. |
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Range of Motion | via goniometer (degrees) | 3 months post-operatively |
| Range of Motion | via goniometer (degrees) | 6 months post-operatively |
| Perceived Pain | via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain) | 1 week post-operatively |
| Perceived Pain | via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain) | 6 week post-operatively |
| Perceived Pain | via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain) | 3 months post-operatively |
| Perceived Pain | via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain) | 6 months post-operatively |
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score | 1 week post-operatively |
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score | 1 week post-operatively |
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score | 1 week post-operatively |
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score | 6 week post-operatively |
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score | 6 week post-operatively |
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score | 6 week post-operatively |
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score | 3 months post-operatively |
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score | 3 months post-operatively |
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score | 3 months post-operatively |
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score | 6 months post-operatively |
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score | 6 months post-operatively |
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score | 6 months post-operatively |
| 12635796 | Background | Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680. |
| 11128848 | Background | Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011. |
| 21917016 | Background | Clark BC, Manini TM, Hoffman RL, Williams PS, Guiler MK, Knutson MJ, McGlynn ML, Kushnick MR. Relative safety of 4 weeks of blood flow-restricted resistance exercise in young, healthy adults. Scand J Med Sci Sports. 2011 Oct;21(5):653-62. doi: 10.1111/j.1600-0838.2010.01100.x. Epub 2010 Mar 11. |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |