Rotator Cuff TendonitisNCT01330641
Accuracy of Needle Placement Into The Subacromial Space of The Shoulder
A study testing Injection of Subacromial Bursa in people with Rotator Cuff Tendonitis, run by University of California, Davis at 1 site in United States.
Trial summary
This study attempts to determine the most accurate route for injection of the subacromial bursa in patients with rotator cuff tendonitis. Typically, in medical practice, one of the routes of injection is used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tendonitis
- What is being tested?
- Injection of Subacromial Bursa
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Mar 2011
- 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
- rotator cuff tendinitis
Who cannot join
- diabetes
- allergy to contrast dye
- renal disease
- pregnancy
- frozen shoulder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Department of Orthopaedic Surgery
Sacramento, California, 95817
About this study
This study attempts to determine the most accurate route for injection of the subacromial bursa in patients with rotator cuff tendonitis. Typically, in medical practice, one of the routes of injection is used. It has not been determined if one route is superior, or if all routes are equal in delivering medication into the subacromial bursa, which sits on top of the rotator cuff tendons.
Read the detailed description
Patients with a diagnosis of rotator cuff tendonitis, having failed other non-operative measures, are offered an injection of steroid and local anesthetic to relieve their pain. This is standard treatment. In this study, patients are prospectively randomized to receive their injection by one of the three commonly used routes: anterior, posterior, or lateral. Accuracy of the injection is determined by including a small amount of contrast dye in the injection which will make the injection visible on post-injection radiographs.
- Conditions
- Rotator Cuff Tendonitis
- Being tested
- Injection of Subacromial Bursa
- Keywords
- Tendonitis, Rotator Cuff, Shoulder, Injection
- Medical subject headings
- Rotator Cuff Injuries, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of Subacromial BursaProcedure or surgery
Injection of steroid and anesthetic to relieve pain
| Study group | Role | What they receive |
|---|---|---|
| Anterior injection Route | Active comparator | Group of patients injected with medication using the anterior route Receives: Procedure: Injection of Subacromial Bursa |
| Posterior Injection | Active comparator | Group of patients receiving injection through a posterior route Receives: Procedure: Injection of Subacromial Bursa |
| Lateral Injection | Active comparator | Group of patients receiving subacromial injection through a lateral route Receives: Procedure: Injection of Subacromial Bursa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic e Radiographic Evidence of Successful Subacromial Injection
After injection of the subacromial bursa, all patients had two view radiographs performed within one hour to assess the accuracy of the injections
Measured: One-hour post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startSep 2008
- Primary completionMay 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendonitisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Investigators
- Richard A Marder, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330641
- Sponsor's protocol ID
- 200816140
- Status last verified
- Apr 2011
- First submitted
- 5 Apr 2011
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Needle Placement Into The Subacromial Space of The Shoulder
- ClinicalTrials.gov ID
- NCT01330641
- Acronym / sponsor ID
- 200816140
- Conditions
- Rotator Cuff Tendonitis
- Keywords
- Tendonitis, Rotator Cuff, Shoulder, Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Apr 2011 (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.
This study attempts to determine the most accurate route for injection of the subacromial bursa in patients with rotator cuff tendonitis. Typically, in medical practice, one of the routes of injection is used. It has not been determined if one route is superior, or if all routes are equal in delivering medication into the subacromial bursa, which sits on top of the rotator cuff tendons.
Detailed description
Patients with a diagnosis of rotator cuff tendonitis, having failed other non-operative measures, are offered an injection of steroid and local anesthetic to relieve their pain. This is standard treatment. In this study, patients are prospectively randomized to receive their injection by one of the three commonly used routes: anterior, posterior, or lateral. Accuracy of the injection is determined by including a small amount of contrast dye in the injection which will make the injection visible on post-injection radiographs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anterior injection Route | Active comparator | Procedure: Injection of Subacromial BursaGroup of patients injected with medication using the anterior route |
| Posterior Injection | Active comparator | Procedure: Injection of Subacromial BursaGroup of patients receiving injection through a posterior route |
| Lateral Injection | Active comparator | Procedure: Injection of Subacromial BursaGroup of patients receiving subacromial injection through a lateral route |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- rotator cuff tendinitis
Key exclusion criteria (5 listed)
- diabetes
- allergy to contrast dye
- renal disease
- pregnancy
- frozen shoulder
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 |
|---|---|---|
| Injection of Subacromial BursaInjection of steroid and anesthetic to relieve pain | Procedure or surgery | Anterior injection Route, Lateral Injection, Posterior Injection |
Primary outcome
Radiographic e Radiographic Evidence of Successful Subacromial Injection
Time frame: One-hour post injection
After injection of the subacromial bursa, all patients had two view radiographs performed within one hour to assess the accuracy of the injections
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 7 Apr 2011.
Related trials for Rotator Cuff Tendonitis
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruiting
Eccentric Contraction Exercise For Shoulder Pain Syndrome
Shoulder Pain Syndrome, Rotator Cuff Syndrome
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.
Richard A Marder, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of Subacromial Bursa in people with Rotator Cuff Tendonitis, run by University of California, Davis 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 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: finished, as of the sponsor's last update on 7 Apr 2011. 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?
Radiographic e Radiographic Evidence of Successful Subacromial Injection (time frame: One-hour post injection). 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 7 Apr 2011; AzTrials last refreshed its copy on 8 Nov 2026.