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

January 30, 2023 updated by: Nuri Tugbay Yildiran, Istanbul University - Cerrahpasa (IUC)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34098
        • Istanbul University- Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ultrasound Guided Lavage Group

The physical examination, pain scoring, functional scale, disability scale, special tests, direct radiography findings and ultrasonographic imaging findings of the patients in this group before the treatment and 1 month after the treatment will be evaluated and will be recorded. Size of calcific deposits and Gartner classification will be evaluated on direct radiography. Size, shape, acoustic shadowing, power doppler activity of calcific deposits and other bursitis, tendinitis, ruptures, effusion in the shoulder will be evaluated on ultrasonographic imaging.

Patients in this group will be treated with ultrasound-guided lavage.
Procedure: Ultrasound Guided Lavage
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
ACTIVE_COMPARATOR: Ultrasound Guided Subacromial Bursa Injection Group

The physical examination, pain scoring, functional scale, disability scale, special tests, direct radiography findings and ultrasonographic imaging findings of the patients in this group before the treatment and 1 month after the treatment will be evaluated and will be recorded. Size of calcific deposits and Gartner classification will be evaluated on direct radiography. Size, shape, acoustic shadowing, power doppler activity of calcific deposits and other bursitis, tendinitis, ruptures, effusion in the shoulder will be evaluated on ultrasonographic imaging.

Patients in this group will be treated with ultrasound-guided subacromial bursa injection with corticosteroid and lidocaine.
Procedure: Ultrasound Guided Subacromial Bursa Injection
2 ml dexamethasone and 3 ml %2 lidocaine will be injected in the subacromial bursa using a 21-gauge needle under ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month
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"
Baseline, 1 hour, 1 month
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.
Baseline, 1 month
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).
Baseline, 1 month
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
Baseline, 1 month
Change in Gartner Score of the Shoulder Calcifications on Direct Radiography
Time Frame: Baseline, 1 month
Radiological classification of calcifying tendinitis
Baseline, 1 month
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.
Baseline, 1 month
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)
Baseline, 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: NURI TUGBAY YILDIRAN, Istanbul University - Cerrahpasa (IUC)
  • Study Director: DENIZ PALAMAR, Istanbul University - Cerrahpasa (IUC)
  • Study Chair: BILGE CAKIR, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 9, 2022

Primary Completion (ACTUAL)

August 30, 2022

Study Completion (ACTUAL)

November 30, 2022

Study Registration Dates

First Submitted

February 20, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (ACTUAL)

March 9, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulUC-NTugbayYildiran-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Shoulder Pain

Clinical Trials on Ultrasound Guided Lavage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe