BFRT for Subacromial Pain

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06873113
Status
Recruiting
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Conditions

  • Shoulder Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Active BFRT — DEVICE
    The BFR device is applied unilaterally on participants involved upper extremity. The BFR device maintains 50% of participants limb occlusion pressure for the duration of each strengthening exercise.
  • Sham BFRT — DEVICE
    The BFR device is applied unilaterally on participants involved upper extremity. The BFR device maintains a pressure of 20mmHg for the duration of each strengthening exercise.
  • Strengthening Exercises with BFRT — BEHAVIORAL
    Participants perform 4 strengthening exercises while using the BFR device: seated scapular plane elevation, prone horizontal abduction, side-lying external rotation, and prone scapular plane elevation. Each exercise is performed unilaterally. Participants perform 1 set of 30 repetitions followed by 3 sets of 15 repetitions (4 total sets, 75 total repetitions). Participants are given 30 seconds rest between sets and 2 minutes of rest between strengthening exercises. Selected resistance for each strengthening exercise is equal to 20% of the participant's maximal force production as measured by handheld dynamometry. Resistance is adjusted weekly.
  • Skilled Physical Therapy Care — BEHAVIORAL
    Participants perform non-strengthening interventions as part of skilled physical therapy care. Non-strengthening interventions include an upper arm ergometer for warm-up, active assisted range of motion of the shoulder, shoulder stretching, shoulder joint mobilizations, and cryotherapy. Non-strengthening interventions are prescribed at the discretion of the treating physical therapist. Participants are enrolled in physical therapy for a minimum of 4 weeks. After 4 weeks, the treating physical therapist can discharge a participant based on their progress in meeting their rehabilitation goals. Participants discharged from skilled physical therapy care will continue to complete strengthening exercises with BFRT until the end of the trial period (8 weeks).

Study Details

The goal of this pilot clinical trial is to learn if blood flow restriction training is safe and feasible in patients with subacromial pain. The main questions the investigators aim to answer are: * What problems do participants with shoulder pain encounter when training with blood flow restriction? * Is it feasible to apply blood flow restriction training as part of a physical therapy intervention? * What are some preliminary effects of blood flow restriction training on the recovery of shoulder function and strength? The investigators will compare active blood flow restriction training to sham (an inactive procedure designed to mimic the active training as closely as possible). Participants will: * Visit the clinic for physical therapy visits and exercise with blood flow restriction training for up to 8 weeks * Visit the clinic for tests before starting the treatment, during the treatment (4 weeks), and after the end of the treatment (8 and 26 weeks).

Key Dates

Start date
May 13, 2025
Status verified
May 2025
Primary completion
Mar 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Active BFRT
  • Sham Comparator: Sham BFRT

Primary Outcome Measure

Recruitment [ Time Frame: Monthly report from beginning to completion of recruitment (anticipated 2 years) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Shea Herlihy, MS
[email protected]
352-273-7361
Federico Pozzi, PT, MA, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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