Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

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ClinicalTrials.gov Identifier: NCT01832376

Recruitment Status : Active, not recruiting

First Posted : April 16, 2013

Last Update Posted : January 23, 2018

Sponsor:

Information provided by (Responsible Party):

Stefan Moosmayer, Martina Hansen's Hospital

Study Description

Brief Summary:

Study population: Subjects with long standing symptoms from calcific tendonitis, non-responsive to other forms of conservative treatment

Study method: A cohort of 50 patients with symptomatic calcific tendonitis will be treated by ultrasound-guided needle lavage. At baseline all study subjects will be assessed by clinical examination, imaging of the shoulder by x-ray and sonography and by the self-report section of the American Shoulder and Elbow Surgeons score (ASES). Follow-up will be performed after 1 and 4 weeks (score only), 3 (clinical, score, ultrasound, x-ray), 6 and 12 months (score only), and after 24 months (clinical, score, ultrasound, x-ray). Patients with insufficient treatment effect will be offered physiotherapy, re-lavage or surgical treatment by acromioplasty.

Purpose of the study: The investigators want to find out

if shoulder function, measured by a shoulder score, will increase during follow-up
how much of the calcific material can be aspirated (in ml)
to which extend the calcific deposit disappears on x-rays and sonographic images
how many patients will need surgical treatment

Condition or disease	Intervention/treatment	Phase
Calcific Tendinitis	Procedure: Ultrasound guided needle lavage	Not Applicable

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage - a Multicenter, Randomized and Sham Controlled Study (KALK Study)
Study Start Date :	June 2011
Actual Primary Completion Date :	February 2016
Estimated Study Completion Date :	February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ultrasound guided needle lavage Ultrasound guided needle lavage	Procedure: Ultrasound guided needle lavage A 18-gauge needle connected to a 5 ml syringe with 4 ml of saline solution will be used to puncture the calcification with freehand technique and under constant sonographic monitoring. With the tip of the needle placed in the center of the deposit, the calcification will be flushed. If backflow of calcific material can be identified in the syringe, lavage of the deposit will be performed by successive propulsion and aspiration with the syringe plunger. In cases where no material can be extracted, repeated perforation of the deposit will be performed to possibly initiate or accelerate spontaneous resorption. Other Name: Barbotage

Arm

Intervention/treatment

Experimental: Ultrasound guided needle lavage

Ultrasound guided needle lavage

Procedure: Ultrasound guided needle lavage

A 18-gauge needle connected to a 5 ml syringe with 4 ml of saline solution will be used to puncture the calcification with freehand technique and under constant sonographic monitoring. With the tip of the needle placed in the center of the deposit, the calcification will be flushed. If backflow of calcific material can be identified in the syringe, lavage of the deposit will be performed by successive propulsion and aspiration with the syringe plunger. In cases where no material can be extracted, repeated perforation of the deposit will be performed to possibly initiate or accelerate spontaneous resorption.

Other Name: Barbotage

Outcome Measures

Primary Outcome Measures :

The self-report section of the American Shoulder and Elbow Surgeons score (ASES) [ Time Frame: Baseline and 24 months ]
The self-report section of the American Shoulder and Elbow Surgeons score (ASES) consists of two equally weighted parts for pain and shoulder function, each contributing 50 points to a maximum score of 100. Pain measurement is performed on a 10 cm visual analogue scale divided into 1 cm increments. Shoulder function is measured by classifying 10 activities of daily living on a four-point ordinal scale. Change in points on the ASES scale from baseline to 24 month follow-up is the primary outcome measure of our study.

Secondary Outcome Measures :

Number of patients who need operative treatment during follow-up [ Time Frame: Baseline to 24 months ]

Other Outcome Measures:

Size of the calcific deposit as determined on X-rays of the affected shoulder [ Time Frame: Baseline to 3 months and 24 months ]
Standardized X-rays of the shoulder are taken at baseline, 3 and 24 month follow-up and the size of the calcific deposits will be measured and compared between examinations

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Shoulder pain for at least 6 months, localised laterally on the upper humerus
Painful arc
Positive Hawkins test and/or Neers tegn for impingement
Calcific deposit of >= 5 mm on shoulder x-ray, verified on sonography with a localisation in the supraspinatus or infraspinatus tendon

Exclusion Criteria:

The presence of other local or systemic diseases affecting shoulder function like arthritis, inflammatory arthropathy or instability
Symptoms from a cervical root syndrome
Sonographic or MRI findings for a rotator cuff tear
Earlier surgery in the study shoulder

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832376

Locations


Norway
Martina Hansens Hospital
Sandvika, Norway, 1306

Sponsors and Collaborators

Martina Hansen's Hospital

Investigators


Principal Investigator:	Stefan Moosmayer, MD, PhD	Martina Hansens Hospital, Sandvika, Norway

More Information


Responsible Party:	Stefan Moosmayer, MD, PhD, Martina Hansen's Hospital
ClinicalTrials.gov Identifier:	NCT01832376 History of Changes
Other Study ID Numbers:	2012/773
First Posted:	April 16, 2013 Key Record Dates
Last Update Posted:	January 23, 2018
Last Verified:	January 2018

Keywords provided by Stefan Moosmayer, Martina Hansen's Hospital:


Calcific tendinitis Shoulder Needle lavage Ultrasound-guided

Additional relevant MeSH terms:


Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries

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