Chronic Refractive Bicipital PainNCT02107586
Comparison of Outcomes Between Biceps Tenotomy and Tenodesis in the Treatment of the Long Head of the Biceps Pathology
A study testing Biceps tenotomy and Biceps tenodesis in people with Chronic Refractive Bicipital Pain, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of the study is to determine what the different outcomes are for biceps tenodesis and tenotomy in the treatment of the long head of the biceps pathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Refractive Bicipital Pain
- What is being tested?
- Biceps tenotomy and Biceps tenodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2013to 8 Apr 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with chronic refractive bicipital pain
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Biceps Tenotomy or Tenodesis in Treating Long Head of the Biceps Pathology: a Prospective Randomized Controlled Trial
The purpose of the study is to determine what the different outcomes are for biceps tenodesis and tenotomy in the treatment of the long head of the biceps pathology.
- Conditions
- Chronic Refractive Bicipital Pain
- Being tested
- Biceps tenotomy, Biceps tenodesis
- Keywords
- biceps tenodesis, biceps tenotomy, biceps tendonitis, biceps inflammation, shoulder surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biceps tenotomyProcedure or surgery
A biceps tenotomy procedure involves cutting of the long head of the biceps just prior to its insertion on the superior labrum of the glenoid.
Biceps tenodesisProcedure or surgery
Biceps tenodesis involves detaching the long head of the biceps from it's superior labrum in the shoulder and reattaching it to the humerus bone just below the shoulder.
| Study group | Role | What they receive |
|---|---|---|
| Biceps tenodesis | Active comparator | 32 subjects in the study will receive biceps tenodesis as a surgical intervention Receives: Procedure: Biceps tenodesis |
| Biceps tenotomy | Active comparator | 32 subjects in the study will receive biceps tenotomy as a surgical intervention Receives: Procedure: Biceps tenotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.
Measured: one year
Secondary outcomes (1)
EuroQol EQ-5D
The questionnaire measures mobility, ability to care for self, ability to perform usual activities, pain/discomfort, and anxiety/depression
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start13 May 2013
- Primary completion8 Apr 2014
- Study completion8 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Refractive Bicipital PainStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lewis L Shi, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107586
- Sponsor's protocol ID
- IRB13-0117
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2014
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biceps Tenotomy or Tenodesis in Treating Long Head of the Biceps Pathology: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02107586
- Acronym / sponsor ID
- IRB13-0117
- Conditions
- Chronic Refractive Bicipital Pain
- Keywords
- biceps tenodesis, biceps tenotomy, biceps tendonitis, biceps inflammation, shoulder surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 13 May 2013 (actual)
- Primary completion
- 8 Apr 2014 (actual)
- Study completion
- 8 Apr 2014 (actual)
- First posted
- 8 Apr 2014 (estimated)
- 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 the study is to determine what the different outcomes are for biceps tenodesis and tenotomy in the treatment of the long head of the biceps pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biceps tenodesis | Active comparator | Procedure: Biceps tenodesis32 subjects in the study will receive biceps tenodesis as a surgical intervention |
| Biceps tenotomy | Active comparator | Procedure: Biceps tenotomy32 subjects in the study will receive biceps tenotomy as a surgical intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient with chronic refractive bicipital pain
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Biceps tenotomyA biceps tenotomy procedure involves cutting of the long head of the biceps just prior to its insertion on the superior labrum of the glenoid. | Procedure or surgery | Biceps tenotomy |
| Biceps tenodesisBiceps tenodesis involves detaching the long head of the biceps from it's superior labrum in the shoulder and reattaching it to the humerus bone just below the shoulder. | Procedure or surgery | Biceps tenodesis |
Primary outcome
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time frame: one year
The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.
1 secondary outcome
EuroQol EQ-5D
Time frame: one year
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 26 Apr 2023.
- 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. This study is not recruiting at the moment.
Lewis L Shi, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biceps tenotomy and Biceps tenodesis in people with Chronic Refractive Bicipital Pain, run by University of Chicago 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 1 inclusion and 1 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 26 Apr 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?
American Shoulder and Elbow Surgeons (ASES) Shoulder Score (time frame: one year). 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 26 Apr 2023.