Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02591953 |
|
Recruitment Status :
Terminated
(Unable to meet enrollment and follow up criteria)
First Posted : October 30, 2015
Last Update Posted : January 8, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Biceps Tendonitis Injection | Procedure: Ultrasound-guidance Procedure: Landmark-guidance Drug: Methylprednisolone Drug: Lidocaine 1% | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 25 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Study Start Date : | November 2015 |
| Actual Primary Completion Date : | May 2019 |
| Actual Study Completion Date : | May 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Ultrasound-guided Injection
Injection performed with ultrasound-guidance
|
Procedure: Ultrasound-guidance
Using ultrasound-guidance to perform a corticosteroid injection Drug: Methylprednisolone Corticosteroid used in injection (40 mg) Drug: Lidocaine 1% Anesthesic used in injection |
|
Active Comparator: Landmark-guided Injection
Injection performed at point of maximal tenderness along biceps tendon
|
Procedure: Landmark-guidance
Using landmark-guidance to perform a corticosteroid injection Drug: Methylprednisolone Corticosteroid used in injection (40 mg) Drug: Lidocaine 1% Anesthesic used in injection |
- ASES Shoulder Score [ Time Frame: 1 year ]Orthopedic Pain and Function Scale
- Speed's Test [ Time Frame: 1 year ]Physical Exam maneuver measured as positive or negative
- Tenderness over Bicepital Groove [ Time Frame: 1 year ]Physical exam maneuver measured as yes or no
- Simple Shoulder Test [ Time Frame: 1 year ]12 question assessment of shoulder function with yes or no answers
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Prior biceps surgery or injections
- Prior SLAP or labral repair
- Concomitant shoulder arthroplasty
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591953
| United States, Illinois | |
| Midwest Orthopeadics at Rush | |
| Chicago, Illinois, United States, 60612 | |
Publications:
| Responsible Party: | Jeremy A Alland, MD, Rush University Medical Center |
| ClinicalTrials.gov Identifier: | NCT02591953 |
| Other Study ID Numbers: |
15101504 |
| First Posted: | October 30, 2015 Key Record Dates |
| Last Update Posted: | January 8, 2021 |
| Last Verified: | January 2021 |
|
Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Lidocaine Prednisolone hemisuccinate Prednisolone phosphate Anesthetics, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Antiemetics Autonomic Agents Gastrointestinal Agents Glucocorticoids Hormones |