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Enrolling by Invitation

NCT Number: NCT06963671

Blood Flow Restriction for Ulnar Sided Wrist Pain

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. Hypothesis: patients in the BFR group with have improved grip strength and patient reported outcome measure scores compared to the control group.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Redwood City, California, 94063, United States

About this study

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.

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. 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. 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. Therapists will use the OMNI-Resistance Exercise Scale for Rate of Perceived Exertion Active Muscles (OMNI-RES RPE-AM) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Flow Restriction

Behavioral

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

Primary outcomes

  1. Grip Strength

    Time frame: From enrollment to 6 weeks after initiation of BRF

    Grip Strength as measured by a dynamometer in pounds.

Secondary outcomes

  1. Patient Reported Wrist Evaluation (PRWE)

    Time frame: 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. This scale is scored from 0-100, and lower scores indicate better function while higher scores indicate worse function.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

What is the Effect of Low-load Blood Flow Restriction Training in the Nonoperative Rehabilitation of Ulnar-sided Wrist Pain?

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 9, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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