Clinical trial NCT06856824: Functional Results of Infiltration for Biceps Tendonitis Guided by Ultrasound vs Anatomical Repairs: Variation in Technique
Official title: Functional Results of Infiltration for Biceps Tendonitis Guided by Ultrasound vs Anatomical Repairs: Variation in Technique
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bíceps Tendinitis
Keywords: Bíceps
Tendinitis
injection
ultrasound
corticosteroid
Lead sponsor: Hospital Universitario San Ignacio
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Javeriana
First posted: 2025-03-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed description: Shoulder pain is a frequent orthopedic complaint, with biceps long head tendinitis being a common cause leading to physical disability in the working and athletic population. Currently, there's no guideline for managing biceps tendinitis. Studying clinical outcomes post-biceps tendon sheath infiltration will aid in developing management guidelines for quick patient return to activities with minimal sequelae.

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).

Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: qDASH
timeFrame: initial measurement before treatment administration, final measurement at 4 weeks.
measure: SANE
timeFrame: initial measurement before treatment administration, follow up at 1, 2, 3 and 4 months
Secondary outcomes:
measure: Visual Analogue Scale (VAS) for Pain Assessment
timeFrame: initial measurement before treatment administration, follow up at 1, 2, 3 and 4 months
measure: Tenderness to palpation
timeFrame: Time Frame initial measurement before treatment administration, final measurement at 4 months.
measure: Speed Test
timeFrame: Time Frame initial measurement before treatment administration, final measurement at 4 months.
measure: Yergason Test
timeFrame: initial measurement before treatment administration, final measurement at 4 months.
measure: Satisfaction with treatment
timeFrame: final measurement at 4 months.
measure: Complications
timeFrame: final measurement at 4 months.
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
Study officials:
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