Ulnar Wrist PainNCT06963671
Blood Flow Restriction for Ulnar Sided Wrist Pain
A study testing Blood Flow Restriction in people with Ulnar Wrist Pain, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulnar Wrist Pain
- What is being tested?
- Blood Flow Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: What is the Effect of Low-load Blood Flow Restriction Training in the Nonoperative Rehabilitation of 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.
Read the 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
- Being tested
- Blood Flow Restriction
- Keywords
- blood flow restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Blood Flow Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Grip Strength as measured by a dynamometer in pounds.
Measured: From enrollment to 6 weeks after initiation of BRF
Secondary outcomes (1)
Patient Reported Wrist Evaluation (PRWE)
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.
Measured: From enrollment to 6 weeks after initiation of BRF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start11 Aug 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulnar Wrist PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Kamal, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963671
- Sponsor's protocol ID
- 80801
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Effect of Low-load Blood Flow Restriction Training in the Nonoperative Rehabilitation of Ulnar-sided Wrist Pain?
- ClinicalTrials.gov ID
- NCT06963671
- Acronym / sponsor ID
- 80801
- Conditions
- Ulnar Wrist Pain
- Keywords
- blood flow restriction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control arm will receive the standard of care treatment for ulnar sided wrist pain |
| Blood Flow Restriction | Experimental | Behavioral: Blood Flow RestrictionThe Blood Flow Restriction group will receive BFR treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow RestrictionThe 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 | Behavioural | Blood Flow Restriction |
Primary outcome
Grip Strength
Time frame: From enrollment to 6 weeks after initiation of BRF
Grip Strength as measured by a dynamometer in pounds.
1 secondary outcome
Patient Reported Wrist Evaluation (PRWE)
Time frame: From enrollment to 6 weeks after initiation of BRF
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction in people with Ulnar Wrist Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Strength (time frame: From enrollment to 6 weeks after initiation of BRF). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.