Biceps TendonitisNCT02591953
Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections
A study testing Ultrasound-guidance, Landmark-guidance and Methylprednisolone in people with Biceps Tendonitis and Injection, run by Rush University Medical Center at 1 site in United States.
Trial summary
Using randomization, prospectively determine superiority of either ultrasound-guided or landmark-guided biceps corticosteroid injections with regard to various clinical variables. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biceps Tendonitis, Injection
- What is being tested?
- Ultrasound-guidance, Landmark-guidance and Methylprednisolone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pain at intertubercular groove
- Anterior humeral pain
- Positive Speed's Test
- Bicep's tendinitis is primary diagnosis for patient
- Patient agrees to follow up and consent
Who cannot join
- Prior biceps surgery or injections
- Prior SLAP or labral repair
- Concomitant shoulder arthroplasty
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwest Orthopeadics at Rush
Chicago, Illinois, 60612
About this study
Using randomization, prospectively determine superiority of either ultrasound-guided or landmark-guided biceps corticosteroid injections with regard to various clinical variables.
Read the detailed description
Patients are diagnosed with biceps tendinitis in the outpatient clinic. After diagnosis, all the patients that meet inclusion/exclusion criteria will be offered to enroll in the study. Study will be described to the patient with regard to protocol and consent. All questions regarding the study will be answered, and it will be explicitly described that the study involvement will not change clinical care. It will be explained that investigators expect a follow up appointment at minimum at three weeks and three months. There may be further follow up requested up to 1 year from enrollment.
After collection of informed consent, the patient will be randomized to either ultrasound-guided or landmark-guided injection. The patient will complete clinical scores at the initial visit prior to the injection. After injection, the patient will have follow up scheduled for three weeks and three months. To ensure patient blinding, an ultrasound will be placed on the patient for both groups, but only active imaging with be performed for the ultrasound-guided patient group. For clinician blinding, a different clinician than the injecting clinician will perform the follow up examinations. The patient is instructed to not seek additional injections or physical therapy during the study.
- Conditions
- Biceps Tendonitis, Injection
- Being tested
- Ultrasound-guidance, Landmark-guidance, Methylprednisolone, Lidocaine 1%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guidanceProcedure or surgery
Using ultrasound-guidance to perform a corticosteroid injection
Landmark-guidanceProcedure or surgery
Using landmark-guidance to perform a corticosteroid injection
Corticosteroid used in injection (40 mg)
Lidocaine 1%Drug
Anesthesic used in injection
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided Injection | Experimental | Injection performed with ultrasound-guidance Receives: Procedure: Ultrasound-guidance; Drug: Methylprednisolone; Drug: Lidocaine 1% |
| Landmark-guided Injection | Active comparator | Injection performed at point of maximal tenderness along biceps tendon Receives: Procedure: Landmark-guidance; Drug: Methylprednisolone; Drug: Lidocaine 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simple Shoulder Test
12 question assessment of shoulder function with yes or no answers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2019
- Study completionMay 2019
Why it stopped: Unable to meet enrollment and follow up criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Biceps TendonitisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy A Alland, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591953
- Sponsor's protocol ID
- 15101504
- Status last verified
- Jul 2022
- First submitted
- 21 Oct 2015
- Last updated
- 18 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Hashiuchi T, Sakurai G, Morimoto M, Komei T, Takakura Y, Tanaka Y. Accuracy of the biceps tendon sheath injection: ultrasound-guided or unguided injection? A randomized controlled trial. J Shoulder Elbow Surg. 2011 Oct;20(7):1069-73. doi: 10.1016/j.jse.2011.04.004. Epub 2011 Jul 22.
PubMed 21782470Zhang J, Ebraheim N, Lause GE. Ultrasound-guided injection for the biceps brachii tendinitis: results and experience. Ultrasound Med Biol. 2011 May;37(5):729-33. doi: 10.1016/j.ultrasmedbio.2011.02.014. Epub 2011 Mar 31.
PubMed 21458143Ucuncu F, Capkin E, Karkucak M, Ozden G, Cakirbay H, Tosun M, Guler M. A comparison of the effectiveness of landmark-guided injections and ultrasonography guided injections for shoulder pain. Clin J Pain. 2009 Nov-Dec;25(9):786-9. doi: 10.1097/AJP.0b013e3181acb0e4.
PubMed 19851159Naredo E, Cabero F, Beneyto P, Cruz A, Mondejar B, Uson J, Palop MJ, Crespo M. A randomized comparative study of short term response to blind injection versus sonographic-guided injection of local corticosteroids in patients with painful shoulder. J Rheumatol. 2004 Feb;31(2):308-14.
PubMed 14760802Aly AR, Rajasekaran S, Ashworth N. Ultrasound-guided shoulder girdle injections are more accurate and more effective than landmark-guided injections: a systematic review and meta-analysis. Br J Sports Med. 2015 Aug;49(16):1042-9. doi: 10.1136/bjsports-2014-093573. Epub 2014 Nov 17.
PubMed 25403682
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections
- ClinicalTrials.gov ID
- NCT02591953
- Acronym / sponsor ID
- 15101504
- Conditions
- Biceps Tendonitis, Injection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to meet enrollment and follow up criteria
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Posted 18 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using randomization, prospectively determine superiority of either ultrasound-guided or landmark-guided biceps corticosteroid injections with regard to various clinical variables.
Detailed description
Patients are diagnosed with biceps tendinitis in the outpatient clinic. After diagnosis, all the patients that meet inclusion/exclusion criteria will be offered to enroll in the study. Study will be described to the patient with regard to protocol and consent. All questions regarding the study will be answered, and it will be explicitly described that the study involvement will not change clinical care. It will be explained that investigators expect a follow up appointment at minimum at three weeks and three months. There may be further follow up requested up to 1 year from enrollment.
After collection of informed consent, the patient will be randomized to either ultrasound-guided or landmark-guided injection. The patient will complete clinical scores at the initial visit prior to the injection. After injection, the patient will have follow up scheduled for three weeks and three months. To ensure patient blinding, an ultrasound will be placed on the patient for both groups, but only active imaging with be performed for the ultrasound-guided patient group. For clinician blinding, a different clinician than the injecting clinician will perform the follow up examinations. The patient is instructed to not seek additional injections or physical therapy during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided Injection | Experimental | Procedure: Ultrasound-guidance, Drug: Methylprednisolone, Drug: Lidocaine 1%Injection performed with ultrasound-guidance |
| Landmark-guided Injection | Active comparator | Procedure: Landmark-guidance, Drug: Methylprednisolone, Drug: Lidocaine 1%Injection performed at point of maximal tenderness along biceps tendon |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pain at intertubercular groove
- Anterior humeral pain
- Positive Speed's Test
- Bicep's tendinitis is primary diagnosis for patient
- Patient agrees to follow up and consent
Key exclusion criteria (3 listed)
- Prior biceps surgery or injections
- Prior SLAP or labral repair
- Concomitant shoulder arthroplasty
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 |
|---|---|---|
| Ultrasound-guidanceUsing ultrasound-guidance to perform a corticosteroid injection | Procedure or surgery | Ultrasound-guided Injection |
| Landmark-guidanceUsing landmark-guidance to perform a corticosteroid injection | Procedure or surgery | Landmark-guided Injection |
| MethylprednisoloneCorticosteroid used in injection (40 mg) | Drug | Landmark-guided Injection, Ultrasound-guided Injection |
| Lidocaine 1%Anesthesic used in injection | Drug | Landmark-guided Injection, Ultrasound-guided Injection |
Primary outcome
Simple Shoulder Test
Time frame: 1 year
12 question assessment of shoulder function with yes or no answers
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21782470Hashiuchi T, Sakurai G, Morimoto M, Komei T, Takakura Y, Tanaka Y. Accuracy of the biceps tendon sheath injection: ultrasound-guided or unguided injection? A randomized controlled trial. J Shoulder Elbow Surg. 2011 Oct;20(7):1069-73. doi: 10.1016/j.jse.2011.04.004. Epub 2011 Jul 22.
- Background: PubMed 21458143Zhang J, Ebraheim N, Lause GE. Ultrasound-guided injection for the biceps brachii tendinitis: results and experience. Ultrasound Med Biol. 2011 May;37(5):729-33. doi: 10.1016/j.ultrasmedbio.2011.02.014. Epub 2011 Mar 31.
- Background: PubMed 19851159Ucuncu F, Capkin E, Karkucak M, Ozden G, Cakirbay H, Tosun M, Guler M. A comparison of the effectiveness of landmark-guided injections and ultrasonography guided injections for shoulder pain. Clin J Pain. 2009 Nov-Dec;25(9):786-9. doi: 10.1097/AJP.0b013e3181acb0e4.
- Background: PubMed 14760802Naredo E, Cabero F, Beneyto P, Cruz A, Mondejar B, Uson J, Palop MJ, Crespo M. A randomized comparative study of short term response to blind injection versus sonographic-guided injection of local corticosteroids in patients with painful shoulder. J Rheumatol. 2004 Feb;31(2):308-14.
- Background: PubMed 25403682Aly AR, Rajasekaran S, Ashworth N. Ultrasound-guided shoulder girdle injections are more accurate and more effective than landmark-guided injections: a systematic review and meta-analysis. Br J Sports Med. 2015 Aug;49(16):1042-9. doi: 10.1136/bjsports-2014-093573. Epub 2014 Nov 17.
- AMSSM Statement of Interventional Musculoskeletal UltrasoundLink provided by the sponsor.
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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 Ultrasound-guidance, Landmark-guidance and Methylprednisolone in people with Biceps Tendonitis and Injection, run by Rush University Medical Center 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 3 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: stopped early, as of the sponsor's last update on 18 Jul 2022. 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?
Yes. Results are posted in the registry (first posted 18 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Simple Shoulder Test (time frame: 1 year). 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 NCT02591953, 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 18 Jul 2022.