Clinical trial NCT06963671: Blood Flow Restriction Study
Official title: What is the Effect of Low-load Blood Flow Restriction Training in the Nonoperative Rehabilitation of Ulnar-sided Wrist Pain?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ulnar Wrist Pain
Keywords: blood flow restriction
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Grip Strength
timeFrame: From enrollment to 6 weeks after initiation of BRF
Secondary outcomes:
measure: Patient Reported Wrist Evaluation (PRWE)
timeFrame: From enrollment to 6 weeks after initiation of BRF
Other outcomes:
Locations:
Study officials:
References: