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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorHospital Universitario San Ignacio

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • injection in the bicipital groove guided by anatomic landmarks

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Anatomic landmarksActive comparator 1 intervention
Group B: Guided by ultrasoundExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
initial measurement before treatment administration, final measurement at 4 weeks.
2

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.

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

Secondary outcomes

1

Visual Analogue Scale (VAS) for Pain Assessment

The VAS is a widely used unidimensional tool for assessing pain intensity in clinical and research settings. It consists of a 10 cm horizontal line where one end represents "no pain" (0 cm) and the other "the worst pain imaginable" (10 cm). The patient is asked to place a mark on the line corresponding to their perceived pain level, and the score is determined by measuring the distance from the "no pain" anchor to the patient's mark in centimeters. Assessment Method: Patients self-report pain by marking a continuous 10 cm line. Pain intensity is quantified by measuring the mark's distance in millimeters (mm) from the zero point (0 mm = no pain, 100 mm = worst pain imaginable). Interpretation: 0-4 mm: No pain 5-44 mm: Mild pain 45-74 mm: Moderate pain 75-100 mm: Severe pain

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

Tenderness to palpation

Pain or discomfort at palpation in the bicipital groove, the escale use is VAS por sus siglas en inglés: Visual Analogue Scale. It consists of a horizontal line of 10 cm (or 100 mm), where one end represents "no pain" (0) and the other end "the worst pain imaginable" (10 or 100, depending on the scale used). The higher the scale value, the worse the patient's health condition and the greater the pain.

Time frame
Time Frame initial measurement before treatment administration, final measurement at 4 months.
3

Speed Test

the patient is asked to extend his elbow and fully supinate his forearm again and to bring his shoulder into 90 degrees of flexion. In this position, the patient is asked to resist downward pressure.the biceps tendon acts like a suspensor cable from its insertion on the superior labrum to the arm. Increased tension in this cable and if inflammation is present is thought to result in pain in the proximal shoulder

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

Yergason Test

The patient should be seated or standing in the anatomical position, with the humerus in a neutral position and the elbow in 90 degrees of flexion in a pronated position. The patient is asked to externally rotate and supinate their arm against the manual resistance of the therapist produced by wrapping the hand around the distal forearm (just above the wrist joint).\[2\] Yergason's Test is considered positive if the pain is reproduced in the bicipital groove and a biceps or a SLAP lesion is suspected. If a "clicking" sensation familiar to the patient is produced during the test, damage to the transverse humeral ligament (which overlies the intertubercular sulcus) should be suspected too

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Universitario San Ignacio

Lead sponsor

Pontificia Universidad Javeriana

Collaborator