Bíceps TendinitisNCT06856824
Functional Results of Infiltration for Biceps Tendonitis Guided by Ultrasound vs Anatomical Repairs: Variation in Technique
A study testing injection in the bicipital groove guided by anatomic landmarks and injection in the bicipital groove guided by ultrasound in people with Bíceps Tendinitis, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bíceps Tendinitis
- What is being tested?
- injection in the bicipital groove guided by anatomic landmarks and injection in the bicipital groove guided by ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Hospital Universitario San Ignacio
Bogotá
Luis A García González, Orthopedic Surgeon and Traumat, * 57 1 5946161 ext. 2253, lagarcia@husi.org.co
About this study
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
Read the 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).
- Conditions
- Bíceps Tendinitis
- Being tested
- injection in the bicipital groove guided by anatomic landmarks, injection in the bicipital groove guided by ultrasound
- Keywords
- Bíceps, Tendinitis, injection, ultrasound, corticosteroid
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection in the bicipital groove guided by anatomic landmarksProcedure or 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 ultrasoundProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Anatomic landmarks | Active comparator | injection in the bicipital groove guided by anatomic landmarks Receives: Procedure: injection in the bicipital groove guided by anatomic landmarks |
| Guided by ultrasound | Experimental | injection in the bicipital groove guided by ultrasound Receives: Procedure: injection in the bicipital groove guided by ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: initial measurement before treatment administration, follow up at 1, 2, 3 and 4 months
Secondary outcomes (6)
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
Measured: initial measurement before treatment administration, follow up at 1, 2, 3 and 4 months
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.
Measured: Time Frame initial measurement before treatment administration, final measurement at 4 months.
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
Measured: Time Frame initial measurement before treatment administration, final measurement at 4 months.
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
Measured: initial measurement before treatment administration, final measurement at 4 months.
Satisfaction with treatment
Satisfaction with treatment is a patient-reported outcome that assesses the perceived effectiveness of the intervention in terms of pain relief and functional recovery.
Measurement Tool:
Question Format: Binary (Yes/No) Type of Variable: Quantitative (Dichotomous)
Assessment Method: Patients will be directly asked:
"Are you satisfied with the treatment in terms of pain relief and functional recovery?" Yes (1): The patient reports being satisfied. No (0): The patient reports not being satisfied.
Interpretation:
A higher percentage of "Yes" responses indicates a greater overall treatment satisfaction rate.
Measured: final measurement at 4 months.
Complications
patients will be evaluated in terms of infection development and biceps tendon rupture as principal complications
Measured: final measurement at 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Bíceps TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856824
- Sponsor's protocol ID
- 2024/070
- Status last verified
- Mar 2025
- First submitted
- 16 May 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25403682Urwin 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.
PubMed 9924205Holtby 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.
PubMed 15007311Dean 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.
PubMed 23429268Borms 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.
PubMed 28125910Griffin 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.
PubMed 28235123Varacallo MA, Mair SD. Proximal Biceps Tendinitis and Tendinopathy. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK533002/
PubMed 30422594Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005 Mar;55(512):224-8.
PubMed 15808040Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.
PubMed 12535501Zhang 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.
PubMed 21458143Elkousy 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.
PubMed 21469629González 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.
PubMed 22005126García 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Results of Infiltration for Biceps Tendonitis Guided by Ultrasound vs Anatomical Repairs: Variation in Technique
- ClinicalTrials.gov ID
- NCT06856824
- Acronym / sponsor ID
- 2024/070
- Conditions
- Bíceps Tendinitis
- Keywords
- Bíceps, Tendinitis, injection, ultrasound, corticosteroid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomic landmarks | Active comparator | Procedure: injection in the bicipital groove guided by anatomic landmarksinjection in the bicipital groove guided by anatomic landmarks |
| Guided by ultrasound | Experimental | Procedure: injection in the bicipital groove guided by ultrasoundinjection in the bicipital groove guided by ultrasound |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection in the bicipital groove guided by anatomic landmarksAnatomical 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. | Procedure or surgery | Anatomic landmarks |
| injection in the bicipital groove guided by ultrasoundAnatomical 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. | Procedure or surgery | Guided by ultrasound |
Primary outcome
qDASH
Time frame: initial measurement before treatment administration, final measurement at 4 weeks.
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
Time frame: initial measurement before treatment administration, follow up at 1, 2, 3 and 4 months
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.
6 secondary outcomes
Visual Analogue Scale (VAS) for Pain Assessment
Time frame: initial measurement before treatment administration, follow up at 1, 2, 3 and 4 months
Tenderness to palpation
Time frame: Time Frame initial measurement before treatment administration, final measurement at 4 months.
Speed Test
Time frame: Time Frame initial measurement before treatment administration, final measurement at 4 months.
Yergason Test
Time frame: initial measurement before treatment administration, final measurement at 4 months.
Satisfaction with treatment
Time frame: final measurement at 4 months.
Complications
Time frame: final measurement at 4 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Background: PubMed 25403682Aly 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.
- Results publication: PubMed 9924205Urwin 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.
- Results publication: PubMed 15007311Holtby 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.
- Results publication: PubMed 23429268Dean 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.
- Results publication: PubMed 28125910Borms 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.
- Results publication: PubMed 28235123Griffin 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.
- Results publication: PubMed 30422594Varacallo MA, Mair SD. Proximal Biceps Tendinitis and Tendinopathy. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK533002/
- Results publication: PubMed 15808040Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005 Mar;55(512):224-8.
- Results publication: PubMed 12535501Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.
- Results publication: PubMed 21458143Zhang 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.
- Results publication: PubMed 21469629Elkousy 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.
- Results publicationGonzález FSV, Shoji FH, Díaz MIE. Lesiones del tendón del bíceps, manejo actual. Orthotips AMOT 2014;10:154-62.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection in the bicipital groove guided by anatomic landmarks and injection in the bicipital groove guided by ultrasound in people with Bíceps Tendinitis, run by Hospital Universitario San Ignacio at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis A A García, MD (*57 1 5946161 ext. 2430, lagarcia@husi.org.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
qDASH (time frame: initial measurement before treatment administration, final measurement at 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06856824, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.