Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal: A Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Strength
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80
- •Undergoing distal biceps tendon repair
排除标准
- •Revision Biceps tendon repair,
- •Irrepairable tendon injury,
- •Biceps repairs with biologic augmentation,
- •Patients with concomitant neurovascular injury,
- •Inability to tolerate BFR treatment,
- •Unable to complete full course of physical therapy,
- •Peripheral vascular disease,
- •History of Venous thromboembolism (VTE)
研究组 & 干预措施
BFR
Patient will use the following rehabilitation protocol while incorporating blood flow restriction therapy:
-
Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only
-
Sling immobilization with active wrist and shoulder ROM
-
Active extension of biceps to 30 degrees, No active flexion
-
6-9 weeks full active extension in brace
-
Maintain wrist and shoulder flexibility
-
Begin rotator cuff/deltoid isometrics, progress active extension in brace
-
Weeks 9-12: Gently advance ROM to tolerance
-
Discontinue sling
-
Begin active flexion and extension against gravity.
-
Advance strength to light resistance, maintain flexibility/ROM
-
Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated
干预措施: Blood Flow Restriction Therapy (Other)
Control (no BFR)
patients will use following rehabilitation protocol without the use of blood flow restriction therapy:
-
Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only
-
Sling immobilization with active wrist and shoulder ROM
-
Active extension of biceps to 30 degrees, No active flexion
-
6-9 weeks full active extension in brace
-
Maintain wrist and shoulder flexibility
-
Begin rotator cuff/deltoid isometrics, progress active extension in brace
-
Weeks 9-12: Gently advance ROM to tolerance
-
Discontinue sling
-
Begin active flexion and extension against gravity.
-
Advance strength to light resistance, maintain flexibility/ROM
-
Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated
结局指标
主要结局
Strength
时间窗: 6 months post-operatively
measured via dynamometer (pounds)
Strength
时间窗: 1 week post-operatively
measured via dynamometer (pounds)
Strength
时间窗: 6 weeks post-operatively
measured via dynamometer (pounds)
Strength
时间窗: 3 months post-operatively
measured via dynamometer (pounds)
次要结局
- Patient reported outcome scores(6 months post-operatively)
- Range of Motion(6 months post-operatively)
- Perceived Pain(6 months post-operatively)
- Range of Motion(1 week post-operatively)
- Range of Motion(6 week post-operatively)
- Range of Motion(3 months post-operatively)
- Perceived Pain(1 week post-operatively)
- Perceived Pain(6 week post-operatively)
- Perceived Pain(3 months post-operatively)
- Patient reported outcome scores(1 week post-operatively)
- Patient reported outcome scores(6 week post-operatively)
- Patient reported outcome scores(3 months post-operatively)
研究者
Charles S Day
Orthopedic Surgeon
Henry Ford Health System