Blood Flow Restriction for Ulnar Sided Wrist Pain

NCT ID: NCT06963671

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-11
• Study Completion Date: 2028-12-31

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. Hypothesis: 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.

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.

Conditions

Ulnar Wrist Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

The control arm will receive the standard of care treatment for ulnar sided wrist pain

Group Type: NO_INTERVENTION

No interventions assigned to this group

Blood Flow Restriction

The Blood Flow Restriction group will receive BFR treatment

Group Type: EXPERIMENTAL

Blood Flow Restriction

Intervention Type: 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

Interventions

Blood Flow Restriction

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Robin Kamal

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Redwood City, California, United States

Countries

United States

Other Identifiers

80801

Identifier Type: -

Identifier Source: org_study_id