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NCT Number: NCT05272085

Comparison of the Efficiency of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis

It is aimed to compare in the early period the clinical and ultrasonographic findings in terms of the effectiveness of ultrasound-guided subacromial bursa injection with corticosteroid and ultrasound-guided lavage, which are the treatment options available in the literature for patients with calcific tendinitis who do not respond to conservative treatment.

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Key information

Conditions

Calcific Tendinitis Arthralgia Arthritis Calcific Tendinitis of Shoulder Chondrocalcinosis Crystal Arthropathies Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rotator Cuff Tear Arthropathy Shoulder Pain Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University- Cerrahpaşa

Istanbul, 34098, Turkey (Türkiye)

About this study

Calcific tendinitis is a disease that occurs with the precipitation of hydroxyapatite crystals on tendons and shoulder region is the most involved. In the shoulder region, calcific tendinitis can involve all rotator cuff tendons, most commonly the supraspinatus. It may progress with pain and functional limitation. The pain can increase with movement or can occur at rest and sleep. The prevalence of calcific tendinitis is between 2.7% and 20% in the general population. The most common age group is between 30 and 60. It can negatively affect the family and social life of the person and cause loss of workforce.

Especially in the treatment of patients with calcific tendinitis unresponsive to conservative treatment, ultrasound-guided corticosteroid injection in subacromial bursa and ultrasound-guided lavage are frequently used treatment options. However, there are very few studies in the literature comparing these two treatment methods as randomized controlled trials.

In this study, it is aimed to compare the effectiveness of ultrasound guided subacromial bursa injection and ultrasound guided lavage procedures on pain scores, functional scales, disability scales, direct radiography findings and ultrasonographic imaging findings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cases diagnosed with calcific tendinitis who did not benefit from conservative treatment
  • Cases with calcific deposits greater than 1 cm in direct radiography, ultrasonography, or magnetic resonance imaging
  • Cases between the ages of 18-75 whose informed consent was obtained for participation in the study

Exclusion criteria

  • Cases with radiculopathy ipsilateral to the affected shoulder
  • Cases with active inflammatory arthropathy of the affected shoulder
  • Cases with previous shoulder surgery
  • Cases with a history of humeral head, scapula, and clavicle fractures
  • Cases with neurological deficit affecting the upper extremity
  • Cases with uncontrolled diabetes mellitus and uncontrolled hypertension, uncompensated congestive heart failure, chronic renal failure, chronic liver disease, tumor and/or vascular disease, inflammatory and/or infectious diseases, currently active psychiatric disease
  • Cases with a history of subacromial bursa injection, calcific lavage or shoulder joint injection in the last 3 months
  • Cases with a history of allergic reaction to the substance to be applied as local anesthetic
  • Pregnancy or lactation
  • Anticoagulant or antiagregant (antiplatelet) medication use that may interfere with the injection procedure.

Treatment and study plan

Ultrasound Guided Lavage

Procedure

After local anesthesia of subcutaneous tissue, lavage will be performed under the guidance of ultrasound using an 18-gauge needle with injectors filled with 4 ml of saline. The needle will be advanced to the center of the calcific deposit. The injector will be kept as parallel to the ground as possible. The plunger of the injector will be pushed with a gently pressure and then released. Calcific deposits are expected to be filled into the syringe along with saline. It is predicted that the clear saline will gradually turn white and become cloudy due to the incoming calcific deposits. When the color of the liquid becomes cloudy, the syringe will be removed without moving the needle, and a new syringe containing 4 ml saline will be placed in its place. Thus, the aspirated calcific deposits will not be reinjected. The same process will be repeated with a new saline filled syringe. After the procedure, 2 ml dexamethasone and 3 ml lidocaine will be injected in subacromial bursa.

Other names: Ultrasound Guided Barbotage

Ultrasound Guided Subacromial Bursa Injection

Procedure

2 ml dexamethasone and 3 ml %2 lidocaine will be injected in the subacromial bursa using a 21-gauge needle under ultrasound guidance.

Primary outcomes

  1. Change of Range of Motion

    Time frame: Baseline, 1 month

    The change in a participant's range of motion degree as measured by a goniometer (Passive Range of Motion and Active Range of Motion) from baseline to 1 month.

  2. Clinical improvement measured by change in Numeric Rating Scale

    Time frame: Baseline, 1 hour, 1 month

    A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. A patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "worst possible pain"

  3. Clinical improvement measured by change in Constant Shoulder Score

    Time frame: Baseline, 1 month

    The constant shoulder score is a validated scale, measuring the shoulder function. It is an objective measurement independent of the shoulder pain. It is a 100-points scale composed of a number of individual parameters. The minimum score is 0, the maximum score is 100 points. The higher the score, the higher the quality of the function.

  4. Clinical improvement measured by change in Quick Dash Score

    Time frame: Baseline, 1 month

    Individual's ability to complete tasks, absorb forces, and severity of symptoms are measured by a 11 item Quick Dash questionnaire. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).

  5. Clinical improvement measured by change in Shoulder Disability Questionnaire

    Time frame: Baseline, 1 month

    This score measures the disability of the shoulder in daily life, work, social life.0 points indicate maximum well-being, 100 points indicate maximum disability

  6. Change in Gartner Score of the Shoulder Calcifications on Direct Radiography

    Time frame: Baseline, 1 month

    Radiological classification of calcifying tendinitis

  7. Change in ultrasound scoring system presented by Chiou

    Time frame: Baseline, 1 month

    This score includes size, shape (arc, fragmented, nodular, cystic), power doppler activity of calcific deposits.

  8. Change in ultrasound classification system of calcific deposits presented by Farin

    Time frame: Baseline, 1 month

    This classification includes acoustic shadowing of calcific deposits (well-defined shadow, faint shadow and no shadow)

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Comparison of the Efficacy of Ultrasound-Guided Lavage and Subacromial Bursa Injection in Calcific Tendinitis: A Prospective, Randomized, Double-Blind Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2022
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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