NCT06963671

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Aug 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Aug 2025Dec 2028

First Submitted

Initial submission to the registry

April 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 11, 2025

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

3.4 years

First QC Date

April 30, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

blood flow restriction

Outcome Measures

Primary Outcomes (1)

  • Grip Strength

    Grip Strength as measured by a dynamometer in pounds.

    From enrollment to 6 weeks after initiation of BRF

Secondary Outcomes (1)

  • Patient Reported Wrist Evaluation (PRWE)

    From enrollment to 6 weeks after initiation of BRF

Study Arms (2)

Control

NO INTERVENTION

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

Blood Flow Restriction

EXPERIMENTAL

The Blood Flow Restriction group will receive BFR treatment

Behavioral: Blood Flow Restriction

Interventions

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

Blood Flow Restriction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 30, 2025

First Posted

May 9, 2025

Study Start

August 11, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations