Clinical trial NCT06223373: Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients
Official title: Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients: Assessment of Efficacy in Return to Activity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Injury
Keywords: Upper extremity injuries
muscle atrophy
tendinopathy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients who will be recruited into randomized into 1 of 2 study arms: 1) those undergoing rehabilitation using Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol or 2) those undergoing rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Atrophy and weakness of the shoulder are a common problem following treatment of a number of shoulder and elbow pathologies. Even with relatively short periods of reduced activity, the magnitude of muscle loss can be quite substantial.

Detailed description: Blood flow restriction (BFR) therapy is one such therapeutic tool that has received increasing attention, which involves application of a pressurized tourniquet to the injured limb during rehabilitation that limits atrophy when performing strength training with weight that otherwise would not produce enough of a contraction to prevent muscular atrophy. To date, several studies have been performed on BFR therapy, however, the effect of therapy on ligamentous and tendinous injury in the upper extremity remain unclear as most studies have focused on muscular strengthening in healthy individuals and on lower extremity injuries distal to the tourniquet.

Eligibility criteria: Inclusion Criteria:

* injured patient with clinical and magnetic resonance imaging (MRI) consistent with a formal diagnosis of non-operative rotator cuff and/or biceps tendinopathy
* no prior upper extremity ipsilateral procedures or history of deep vein thrombosis
* those willing to be part of the study

Exclusion Criteria:

* patients younger than 18 or older than 55 years of age
* a history of revision surgery or prior ipsilateral upper extremity surgery
* concomitant ligamentous, tendinous, or cartilage injury that would alter postoperative rehabilitation protocol
* inability to comply with the proposed follow-up clinic visits
* patients lacking decisional capacity

Primary outcomes:
measure: Change in Shoulder muscle strength
timeFrame: Week 6
measure: Change in cross sectional area (CSA)
timeFrame: Week 6
measure: functional Shoulder scores - Return to Sport up to Month 12
timeFrame: Return to Sport up to Month 12
measure: functional Shoulder scores - Baseline
timeFrame: Baseline
measure: functional Shoulder scores - Month 6
timeFrame: Month 6
measure: functional Shoulder scores - Month 12
timeFrame: Month 12
measure: GH levels - Baseline
timeFrame: Baseline
measure: GH levels - Day 1
timeFrame: Day 1
measure: GH levels - Week 3
timeFrame: Week 3
measure: GH levels - Week 6
timeFrame: Week 6
measure: IL-6 levels - Baseline
timeFrame: Baseline
measure: IL-6 levels - Day 1
timeFrame: Day 1
measure: IL-6 levels - Week 3
timeFrame: Week 3
measure: IL-6 levels - Week 6
timeFrame: Week 6
measure: IGF-1 levels - Baseline
timeFrame: Baseline
measure: IGF-1 levels - Day 1
timeFrame: Day 1
measure: IGF-1 levels - Week 3
timeFrame: Week 3
measure: IGF-1 levels - Week 6
timeFrame: Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kristen Nicholson, MD
role: PRINCIPAL_INVESTIGATOR
References: