Blood Flow Restriction Study

Not Applicable

Not yet recruiting

• Conditions: Ulnar Wrist Pain

• Registration Number: NCT06963671
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this study is to determine the strength, pain and functional benefits of early, low-load resistance training with blood flow restriction (BFR) in ulnar-sided wrist pain treated nonoperatively with immobilization for 4-6 weeks. We hypothesize that patients in the BFR group with have improved grip strength and patient reported outcome measure scores compared to the control group.

Detailed Description

Patients presenting to the hand therapy or hand surgery clinic who meet inclusion criteria will be screened, consented, and enrolled. This will include administration of the blood flow restriction screening questionnaire (Appendix A).

Patients with non operatively managed ulnar-sided wrist pain, who have been immobilized for at least 4 weeks 0 days, but no more than 6 weeks 6 days, and are referred to Stanford's Hand Therapy clinic, will receive either standard care or a standard care home program with low-load strengthening under a blood flow restricted (BFR) condition during their therapy sessions (Appendix B). Patients will be assigned to groups in simultaneous enrollment in two arms. The control group will receive standard rehabilitation during therapy visits plus a home program that will be dictated based on the associated phase of rehabilitation 8 (Appendix C). The treatment group will receive standard rehabilitation as a home program plus low-load resistance training with BFR application while at the hand therapy clinic for their appointments, both of which will be dictated based on the associated phase of rehabilitation (Appendix D). Therapists will use the OMNI-Resistance Exercise Scale for Rate of Perceived Exertion Active Muscles (OMNI-RES RPE-AM) (Appendix E) to grade all strengthening exercises for each individual in both groups. The target RPE-AM for each exercise will be 7-9 by the last set for resistance exercises in both control and treatment groups.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Study Start: 2025-09-01
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• All patients (>18 years) undergoing outpatient rehabilitation at Stanford Hand Therapy
• English fluency and literacy
• Able to take informed consent
• Have acute or chronic ulnar-sided wrist pain referred for a course of hand therapy by a physician or advanced practice provider (APP) and were treated with continuous immobilization for 4-6 weeks.
• Score of 3 or less on blood flow restriction screening questionnaire

Exclusion Criteria

• Concomitant injuries such as upper extremity fractures or other ligamentous injuries
• TFCC surgery in the affected wrist
• Non-compliance with immobilization
• Patients who complete hand therapy at an outside facility
• Score of 4 or more on blood flow restriction screening questionnaire

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Grip Strength	From enrollment to 6 weeks after initiation of BRF	Grip Strength as measured by a dynamometer in pounds.

Secondary Outcome Measures

Name	Time	Method
Patient Reported Wrist Evaluation (PRWE)	From enrollment to 6 weeks after initiation of BRF	The PRWE is a patient-reported outcome measure created to measure wrist pain and disability in activities of daily living