Functional Results of Infiltration for Biceps Tendonitis Guided by Ultrasound vs Anatomical Repairs: Variation in Technique
NCT ID: NCT06856824
Last Updated: 2025-03-17
Study Results
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Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-06-01
2025-12-31
Brief Summary
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Detailed Description
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No studies in Colombia have compared clinical outcomes of biceps tendinitis patients undergoing ultrasound-guided vs anatomically guided infiltrations. This information will allow comparison with global literature, assessing differences in treatment effectiveness and socio-economic impact on the population.
Research Question:
In patients with long head biceps tendinitis, does ultrasound-guided infiltration compared to anatomically guided infiltration yield better clinical outcomes?
Theoretical Framework and State of the Art:
The biceps tendon originates from the supraglenoid tubercle of the scapula, contributing to shoulder stability and functions such as forearm supination and elbow flexion. Primary biceps tendinitis, constituting about 5% of bicipital pathology cases, can limit daily activities.
Tendinitis cascade initiation involves inflammation due to repetitive traction, leading to increased tendon volume and pressure in specific locations, predisposing it to shear forces and degenerative changes. Diagnosis involves ultrasound and MRI, with initial treatment focusing on non-surgical methods and corticosteroid infiltrations when conservative management fails.
Ultrasound-guided injections, compared to anatomical landmarks, show higher precision and efficacy rates, reducing patient discomfort.
Procedure Technique:
Anatomical landmark-guided puncture involves patient positioning and palpation, whereas ultrasound-guided involves identifying the biceps tendon's axis and inserting the needle parallel to the transducer.
Objectives:
General Objective: To compare functional outcomes of biceps tendon sheath infiltration guided by anatomical landmarks versus ultrasound in biceps tendinitis patients.
Specific Objectives: Characterize patient demographics, describe complication incidence, compare complication incidence between groups, and compare clinical outcomes between techniques.
Hypotheses:
Null Hypothesis: Ultrasound-guided infiltration yields similar functional results as anatomical landmark-guided infiltration in biceps tendinitis patients.
Alternative Hypothesis: Ultrasound-guided infiltration yields better functional results than anatomical landmark-guided infiltration in biceps tendinitis patients.
Methodology:
This entails a randomized clinical trial with double-blind methodology, involving RedCap software for randomization. Patients are blinded to the procedure, while the applicator knows the procedure but outcome evaluators are blinded.
Anatomical Landmark-guided Puncture:
The patient is placed in the supine position with the shoulder at a 10° internal rotation angle. Identification involves palpation of the coracoid process, tuberosities, biceps tendon, and bicipital groove. The tuberosities and biceps tendon groove are marked at the presumed tendon location. Confirmation of tendon location is achieved through palpation with rotations and manual palpation (highlighting 5 to 7 cm distal to the anterolateral margin of the acromion). A 5cc syringe with a 0.8 x 40 mm 21G ½ needle is used for puncture, inclined at a 20° to 30° cephalic angle until the biceps tendon sheath is pierced. During the procedure, ultrasound machine and transducer positioning will be performed, although the device will remain turned off.
Ultrasound-guided Puncture:
The patient is positioned supine with the shoulder in a neutral rotation. Identification involves locating the axis of the long head biceps tendon. The transducer is positioned perpendicular to the synovial sheath. The needle is inserted parallel to the transducer along its long axis from the lateral side of the shoulder. The needle is visualized on the monitor as a hyperechoic image and advanced continuously and in real-time into the tendon sheath. A 5cc syringe with a 0.8 x 40 mm 21G ½ needle is used for puncture. This procedure is performed by a specialist trained in ultrasound.
General Objective Compare the functional outcomes of bicipital groove infiltration guided by anatomical landmarks and by ultrasound as a technique variation in patients with biceps tendinitis.
Specific Objectives
Characterize demographic variables in the study patient groups. Describe the incidence of complications related to the procedures. Compare the incidence of complications between the groups. Compare clinical outcomes between the two techniques (EVA, qDASH, SANE, satisfaction).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Anatomic landmarks
injection in the bicipital groove guided by anatomic landmarks
injection in the bicipital groove guided by anatomic landmarks
Anatomical landmark-guided puncture involves patient positioning and palpation, whereas ultrasound-guided involves identifying the biceps tendon's axis and inserting the needle parallel to the transducer.
Guided by ultrasound
injection in the bicipital groove guided by ultrasound
injection in the bicipital groove guided by ultrasound
Anatomical landmark-guided puncture involves patient positioning and palpation, whereas ultrasound-guided involves identifying the biceps tendon's axis and inserting the needle parallel to the transducer.
Interventions
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injection in the bicipital groove guided by anatomic landmarks
Anatomical landmark-guided puncture involves patient positioning and palpation, whereas ultrasound-guided involves identifying the biceps tendon's axis and inserting the needle parallel to the transducer.
injection in the bicipital groove guided by ultrasound
Anatomical landmark-guided puncture involves patient positioning and palpation, whereas ultrasound-guided involves identifying the biceps tendon's axis and inserting the needle parallel to the transducer.
Eligibility Criteria
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Inclusion Criteria
* Patients with anterior shoulder pain
* Point of maximum pain in long head bíceps tendon at the level of the bicipital groove
* Positive speed test
* Patients who gave informed consent and accepted follow-up
Exclusion Criteria
* Partial or complete rupture of the subscapularis tendon
* Glenohumeral joint deformity
* Rupture and/or dislocation of the tendon of the long head of the biceps.
* Surgery and/or previous infiltrations in the biceps tendon
18 Years
99 Years
ALL
No
Sponsors
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Pontificia Universidad Javeriana
OTHER
Hospital Universitario San Ignacio
OTHER
Responsible Party
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Locations
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Hospital Universitario San Ignacio
Bogotá, , Colombia
Countries
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Central Contacts
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Facility Contacts
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Luis A García González, Orthopedic Surgeon and Traumat
Role: primary
References
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Aly 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.
Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, Simmons A, Williams G. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998 Nov;57(11):649-55. doi: 10.1136/ard.57.11.649.
Holtby R, Razmjou H. Accuracy of the Speed's and Yergason's tests in detecting biceps pathology and SLAP lesions: comparison with arthroscopic findings. Arthroscopy. 2004 Mar;20(3):231-6. doi: 10.1016/j.arthro.2004.01.008.
Dean BJ, Gwilym SE, Carr AJ. Why does my shoulder hurt? A review of the neuroanatomical and biochemical basis of shoulder pain. Br J Sports Med. 2013 Nov;47(17):1095-104. doi: 10.1136/bjsports-2012-091492. Epub 2013 Feb 21.
Borms D, Ackerman I, Smets P, Van den Berge G, Cools AM. Biceps Disorder Rehabilitation for the Athlete: A Continuum of Moderate- to High-Load Exercises. Am J Sports Med. 2017 Mar;45(3):642-650. doi: 10.1177/0363546516674190. Epub 2016 Dec 14.
Griffin JW, Leroux TS, Romeo AA. Management of Proximal Biceps Pathology in Overhead Athletes: What Is the Role of Biceps Tenodesis? Am J Orthop (Belle Mead NJ). 2017 Jan/Feb;46(1):E71-E78.
Varacallo MA, Mair SD. Proximal Biceps Tendinitis and Tendinopathy. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK533002/
Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005 Mar;55(512):224-8.
Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.
Zhang 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.
Elkousy H, Gartsman GM, Drake G, Sola W Jr, O'Connor D, Edwards TB. Retrospective comparison of freehand and ultrasound-guided shoulder steroid injections. Orthopedics. 2011 Apr 11;34(4). doi: 10.3928/01477447-20110228-11.
González FSV, Shoji FH, Díaz MIE. Lesiones del tendón del bíceps, manejo actual. Orthotips AMOT 2014;10:154-62.
Khazzam M, George MS, Churchill RS, Kuhn JE. Disorders of the long head of biceps tendon. J Shoulder Elbow Surg. 2012 Jan;21(1):136-45. doi: 10.1016/j.jse.2011.07.016. Epub 2011 Oct 17. No abstract available.
García González GLA, Aguilar Sierra SF, Rodríguez Ricardo RMC. Validación de la versión en español de la escala de función del miembro superior abreviada: Quick Dash. Revista Colombiana de Ortopedia Y Traumatología 2018;32:215-9.
Dhand NK, Khatkar MS. Statulator: An online statistical calculator. Sample size calculator for comparing two independent means. Accessed May 2014;6:2021.
Other Identifiers
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2024/070
Identifier Type: -
Identifier Source: org_study_id
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