Bicep Tendon RuptureNCT04503421

Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal Biceps Tendon Repair

A study testing Blood Flow Restriction Therapy in people with Bicep Tendon Rupture, run by Henry Ford Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Bicep Tendon Rupture
What is being tested?: Blood Flow Restriction Therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: 15 Aug 2020to 15 Sep 2021
Phase: Interventional
Are there results?: None posted in the registry

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-80
Undergoing distal biceps tendon repair

Who cannot join

Revision Biceps tendon repair,
Irrepairable tendon injury,
Biceps repairs with biologic augmentation,
Patients with concomitant neurovascular injury,
Inability to tolerate BFR treatment,
Unable to complete full course of physical therapy,
Peripheral vascular disease,
History of Venous thromboembolism (VTE)

Trial locations and contacts

1 site in 1 country.

United States1 site

Health Ford Health System
Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal: A Prospective Randomized Control Trial

The goal of this investigation is to determine if using BFR during postoperative therapy would lead to increased and expedited strength gains. Additionally, the investigators would like to determine if BFR is beneficial in preventing muscle atrophy and fatty infiltration in the setting of bicep tendon tears, due to the altered tension-length relationship following surgery. The study will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding distal biceps tear and surgical repair

Conditions: Bicep Tendon Rupture
Being tested: Blood Flow Restriction Therapy
Keywords: blood flow restriction, Rehabilitation, Physical therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood Flow Restriction TherapyOther
Use of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy

Study groups in NCT04503421
Study group	Role	What they receive
BFR	Experimental	Patient will use the following rehabilitation protocol while incorporating blood flow restriction therapy: * Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only * Sling immobilization with active wrist and shoulder ROM * Active extension of biceps to 30 degrees, No active flexion * 6-9 weeks full active extension in brace * Maintain wrist and shoulder flexibility * Begin rotator cuff/deltoid isometrics, progress active extension in brace * Weeks 9-12: Gently advance ROM to tolerance * Discontinue sling * Begin active flexion and extension against gravity. * Advance strength to light resistance, maintain flexibility/ROM * Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated Receives: Other: Blood Flow Restriction Therapy
Control (no BFR)	No intervention	patients will use following rehabilitation protocol without the use of blood flow restriction therapy: * Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only * Sling immobilization with active wrist and shoulder ROM * Active extension of biceps to 30 degrees, No active flexion * 6-9 weeks full active extension in brace * Maintain wrist and shoulder flexibility * Begin rotator cuff/deltoid isometrics, progress active extension in brace * Weeks 9-12: Gently advance ROM to tolerance * Discontinue sling * Begin active flexion and extension against gravity. * Advance strength to light resistance, maintain flexibility/ROM * Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated

What is being measured

The primary outcome is the main question the study is designed to answer.

Strength
measured via dynamometer (pounds)
Measured: 1 week post-operatively
Strength
measured via dynamometer (pounds)
Measured: 6 weeks post-operatively
Strength
measured via dynamometer (pounds)
Measured: 3 months post-operatively
Strength
measured via dynamometer (pounds)
Measured: 6 months post-operatively

Secondary outcomes (20)

Range of Motion
via goniometer (degrees)
Measured: 1 week post-operatively
Range of Motion
via goniometer (degrees)
Measured: 6 week post-operatively
Range of Motion
via goniometer (degrees)
Measured: 3 months post-operatively
Range of Motion
via goniometer (degrees)
Measured: 6 months post-operatively
Perceived Pain
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Measured: 1 week post-operatively
Perceived Pain
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Measured: 6 week post-operatively
Perceived Pain
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Measured: 3 months post-operatively
Perceived Pain
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Measured: 6 months post-operatively
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
Measured: 1 week post-operatively
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
Measured: 1 week post-operatively
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
Measured: 1 week post-operatively
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
Measured: 6 week post-operatively
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
Measured: 6 week post-operatively
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
Measured: 6 week post-operatively
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
Measured: 3 months post-operatively
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
Measured: 3 months post-operatively
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
Measured: 3 months post-operatively
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
Measured: 6 months post-operatively
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
Measured: 6 months post-operatively
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
Measured: 6 months post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 202015 Sep 2021

First posted7 Aug 2020
Study start15 Aug 2020
Primary completion15 Aug 2021
Study completion15 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Bicep Tendon RuptureStudies of the same condition, open and under way.
More trials run by Henry Ford Health SystemThe 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04503421
Sponsor's protocol ID: Henry - IRB00000253
Status last verified: Dec 2023
First submitted: 28 Jul 2020
Last updated: 8 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Wernbom M, Augustsson J, Raastad T. Ischemic strength training: a low-load alternative to heavy resistance exercise? Scand J Med Sci Sports. 2008 Aug;18(4):401-16. doi: 10.1111/j.1600-0838.2008.00788.x. Epub 2008 May 3.
PubMed 18466185
Huynh T, Leiter J, MacDonald PB, Dubberley J, Stranges G, Old J, Marsh J. Outcomes and Complications After Repair of Complete Distal Biceps Tendon Rupture with the Cortical Button Technique. JB JS Open Access. 2019 Aug 27;4(3):e0013.1-6. doi: 10.2106/JBJS.OA.19.00013. eCollection 2019 Jul-Sep.
PubMed 31592499
Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680.
PubMed 12635796
Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011.
PubMed 11128848
Clark BC, Manini TM, Hoffman RL, Williams PS, Guiler MK, Knutson MJ, McGlynn ML, Kushnick MR. Relative safety of 4 weeks of blood flow-restricted resistance exercise in young, healthy adults. Scand J Med Sci Sports. 2011 Oct;21(5):653-62. doi: 10.1111/j.1600-0838.2010.01100.x. Epub 2010 Mar 11.
PubMed 21917016

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears
Rotator Cuff Tears, Rotator Cuff Injuries
Not yet recruiting
Percutaneous Tenotomy Versus Radiofrequency Ablation for Rotator Cuff Tear - Related Pain.
Rotator Cuff Tear, Pain Management
Recruiting
Biceps Lasso Loop and Self- Locking Tenodesis Alongside Repair of Rotator Cuff Tears: Randomised Controlled Trial Study Protocol (BLAST 1)
Rotator Cuff Injury
Recruiting
Electroacupuncture and Cupping for Shoulder Tendinitis
Shoulder Tendinopathy, Shoulder Tendinitis
Not yet recruiting
Clinical Trial to Compare Clinical and Functional Results of the Augmentation of Supraspinatus Tears With the Long Head of the Biceps Brachii Tendon
Rotator Cuff Tear Surgical Repair

All Bicep Tendon Rupture trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal: A Prospective Randomized Control Trial
ClinicalTrials.gov ID: NCT04503421
Acronym / sponsor ID: Henry - IRB00000253
Conditions: Bicep Tendon Rupture
Keywords: blood flow restriction, Rehabilitation, Physical therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Henry Ford Health SystemUniversity, hospital or other
Study start: 15 Aug 2020 (actual)
Primary completion: 15 Aug 2021 (actual)
Study completion: 15 Sep 2021 (actual)
First posted: 7 Aug 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BFR	Experimental	Other: Blood Flow Restriction TherapyPatient will use the following rehabilitation protocol while incorporating blood flow restriction therapy: * Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only * Sling immobilization with active wrist and shoulder ROM * Active extension of biceps to 30 degrees, No active flexion * 6-9 weeks full active extension in brace * Maintain wrist and shoulder flexibility * Begin rotator cuff/deltoid isometrics, progress active extension in brace * Weeks 9-12: Gently advance ROM to tolerance * Discontinue sling * Begin active flexion and extension against gravity. * Advance strength to light resistance, maintain flexibility/ROM * Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated
Control (no BFR)	No intervention	–patients will use following rehabilitation protocol without the use of blood flow restriction therapy: * Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only * Sling immobilization with active wrist and shoulder ROM * Active extension of biceps to 30 degrees, No active flexion * 6-9 weeks full active extension in brace * Maintain wrist and shoulder flexibility * Begin rotator cuff/deltoid isometrics, progress active extension in brace * Weeks 9-12: Gently advance ROM to tolerance * Discontinue sling * Begin active flexion and extension against gravity. * Advance strength to light resistance, maintain flexibility/ROM * Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Age 18-80
Undergoing distal biceps tendon repair

Key exclusion criteria (8 listed)

Revision Biceps tendon repair,
Irrepairable tendon injury,
Biceps repairs with biologic augmentation,
Patients with concomitant neurovascular injury,
Inability to tolerate BFR treatment,

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 Restriction TherapyUse of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy	Other	BFR

Primary outcome

Strength
Time frame: 1 week post-operatively
measured via dynamometer (pounds)
Strength
Time frame: 6 weeks post-operatively
measured via dynamometer (pounds)
Strength
Time frame: 3 months post-operatively
measured via dynamometer (pounds)
Strength
Time frame: 6 months post-operatively
measured via dynamometer (pounds)

20 secondary outcomes

Range of Motion
Time frame: 1 week post-operatively
Range of Motion
Time frame: 6 week post-operatively
Range of Motion
Time frame: 3 months post-operatively
Range of Motion
Time frame: 6 months post-operatively
Perceived Pain
Time frame: 1 week post-operatively
Perceived Pain
Time frame: 6 week post-operatively
Perceived Pain
Time frame: 3 months post-operatively
Perceived Pain
Time frame: 6 months post-operatively
Patient reported outcome scores
Time frame: 1 week post-operatively
Patient reported outcome scores
Time frame: 1 week post-operatively
Patient reported outcome scores
Time frame: 1 week post-operatively
Patient reported outcome scores
Time frame: 6 week post-operatively
Patient reported outcome scores
Time frame: 6 week post-operatively
Patient reported outcome scores
Time frame: 6 week post-operatively
Patient reported outcome scores
Time frame: 3 months post-operatively
Patient reported outcome scores
Time frame: 3 months post-operatively
Patient reported outcome scores
Time frame: 3 months post-operatively
Patient reported outcome scores
Time frame: 6 months post-operatively
Patient reported outcome scores
Time frame: 6 months post-operatively
Patient reported outcome scores
Time frame: 6 months post-operatively

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
Background: PubMed 18466185Wernbom M, Augustsson J, Raastad T. Ischemic strength training: a low-load alternative to heavy resistance exercise? Scand J Med Sci Sports. 2008 Aug;18(4):401-16. doi: 10.1111/j.1600-0838.2008.00788.x. Epub 2008 May 3.
Background: PubMed 31592499Huynh T, Leiter J, MacDonald PB, Dubberley J, Stranges G, Old J, Marsh J. Outcomes and Complications After Repair of Complete Distal Biceps Tendon Rupture with the Cortical Button Technique. JB JS Open Access. 2019 Aug 27;4(3):e0013.1-6. doi: 10.2106/JBJS.OA.19.00013. eCollection 2019 Jul-Sep.
Background: PubMed 12635796Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680.
Background: PubMed 11128848Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011.
Background: PubMed 21917016Clark BC, Manini TM, Hoffman RL, Williams PS, Guiler MK, Knutson MJ, McGlynn ML, Kushnick MR. Relative safety of 4 weeks of blood flow-restricted resistance exercise in young, healthy adults. Scand J Med Sci Sports. 2011 Oct;21(5):653-62. doi: 10.1111/j.1600-0838.2010.01100.x. Epub 2010 Mar 11.
Individual participant dataSharing planned: Undecided

Related trials for Bicep Tendon Rupture

Recruiting
Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears
Rotator Cuff Tears, Rotator Cuff Injuries
Not yet recruiting
Percutaneous Tenotomy Versus Radiofrequency Ablation for Rotator Cuff Tear - Related Pain.
Rotator Cuff Tear, Pain Management
Recruiting
Biceps Lasso Loop and Self- Locking Tenodesis Alongside Repair of Rotator Cuff Tears: Randomised Controlled Trial Study Protocol (BLAST 1)
Rotator Cuff Injury
Recruiting
Electroacupuncture and Cupping for Shoulder Tendinitis
Shoulder Tendinopathy, Shoulder Tendinitis
Not yet recruiting
Clinical Trial to Compare Clinical and Functional Results of the Augmentation of Supraspinatus Tears With the Long Head of the Biceps Brachii Tendon
Rotator Cuff Tear Surgical Repair

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. This study is not recruiting at the moment.

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 Therapy in people with Bicep Tendon Rupture, run by Henry Ford Health System 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 8 Dec 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Strength (time frame: 1 week post-operatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04503421, which also lists 5 linked publications.

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 8 Dec 2023.