Functional Results of Infiltration for Biceps Tendonitis Guided by Ultrasound vs Anatomical Repairs: Variation in Technique

NCT06856824 | Recruiting

• 1 other identifier: 2024/070
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized clinical trial aimed at comparing the functional outcomes of brachial biceps infiltration guided by anatomical landmarks versus ultrasound guidance. Given that ultrasound guidance has shown an efficacy of 91%, this intervention could potentially be more effective in delivering medication to the target area and achieving improved therapeutic outcomes

Conditions

Bíceps Tendinitis

Keywords

Bíceps; Tendinitis; injection; ultrasound; corticosteroid

Outcome Measures

Primary Outcomes (2)

• qDASH

  The QuickDASH, published in 2005 in the Journal of Bone and Joint Surgery, is an 11-item subset of the 30-item DASH and is a self-report questionnaire in which response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and scores range from MINIMUM 0 to 100. 0 is the minimum score and 100 is the maximum score. 0 indicates no disability and 100 indicates more severe disability. Higher scores indicate worse outcome. This score was designed to be useful in patients with any upper extremity musculoskeletal disorder.

  initial measurement before treatment administration, final measurement at 4 weeks.

• SANE

  The Single Assessment Numeric Evaluation (SANE) is a quick assessment tool that asks patients to rate their affected joint function as a percentage of normal, where 100% represents normal function and 0% indicates completely abnormal function. Thus, the maximum score is 100%, and the minimum is 0%. A higher score reflects a better perception of function by the patient. For example, a score of 85% suggests that the patient perceives their joint function at 85% of what they consider normal. Studies have shown that initial SANE scores typically range between 40% and 60% before treatment, improving to 75% to 85% one year after therapy, depending on the condition treated.

  initial measurement before treatment administration, follow up at 1, 2, 3 and 4 months

Secondary Outcomes (6)

• Visual Analogue Scale (VAS) for Pain Assessment

  initial measurement before treatment administration, follow up at 1, 2, 3 and 4 months

• Tenderness to palpation

  Time Frame initial measurement before treatment administration, final measurement at 4 months.

• Speed Test

  Time Frame initial measurement before treatment administration, final measurement at 4 months.

• Yergason Test

  initial measurement before treatment administration, final measurement at 4 months.

• Satisfaction with treatment

  final measurement at 4 months.

Study Arms (2)

Anatomic landmarks

ACTIVE COMPARATOR

injection in the bicipital groove guided by anatomic landmarks

Procedure: injection in the bicipital groove guided by anatomic landmarks

Guided by ultrasound

EXPERIMENTAL

injection in the bicipital groove guided by ultrasound

Procedure: injection in the bicipital groove guided by ultrasound

Interventions

injection in the bicipital groove guided by anatomic landmarks PROCEDURE

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.

Anatomic landmarks

injection in the bicipital groove guided by ultrasound PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• 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

You may not qualify if:

• Calcifying tendonitis of the biceps
• 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

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead
• Pontificia Universidad Javeriana: collaborator

Study Sites (1)

Hospital Universitario San Ignacio

Bogotá, Colombia

RECRUITING

Related Publications (15)

• 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.

  PMID: 25403682 BACKGROUND

• 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.

  PMID: 9924205 RESULT

• 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.

  PMID: 15007311 RESULT

• 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.

  PMID: 23429268 RESULT

• 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.

  PMID: 28125910 RESULT

• 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.

  PMID: 28235123 RESULT

• 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/

  PMID: 30422594 RESULT

• Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005 Mar;55(512):224-8.

  PMID: 15808040 RESULT

• Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.

  PMID: 12535501 RESULT

• 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.

  PMID: 21458143 RESULT

• 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.

  PMID: 21469629 RESULT

• González FSV, Shoji FH, Díaz MIE. Lesiones del tendón del bíceps, manejo actual. Orthotips AMOT 2014;10:154-62.

  RESULT

• 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.

  PMID: 22005126 RESULT

• 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.

  RESULT

• Dhand NK, Khatkar MS. Statulator: An online statistical calculator. Sample size calculator for comparing two independent means. Accessed May 2014;6:2021.

  RESULT

MeSH Terms

Conditions

Tendinopathy

Interventions

Injections

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Luis A A García, MD

CONTACT

*57 1 5946161; lagarcia@husi.org.co

Margarita Manrique, MD

CONTACT

5946161; mmmanrique@husi.org.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: March 4, 2025
• Study Start: June 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)