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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
injection in the bicipital groove guided by anatomic landmarks
Procedure/SurgeryAnatomical 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/SurgeryAnatomical 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
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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
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.
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
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
Sponsors and contacts
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Hospital Universitario San Ignacio
Lead sponsor
Pontificia Universidad Javeriana
Collaborator