Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage - Full Text View

Purpose

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	Intervention
Calcific Tendinitis	Procedure: Ultrasound guided needle lavage


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

Further study details as provided by Martina Hansen's Hospital:

Primary Outcome Measures:

The self-report section of the American Shoulder and Elbow Surgeons score (ASES) [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
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


Estimated Enrollment:	50
Study Start Date:	June 2011
Estimated Study Completion Date:	February 2018
Primary Completion Date:	February 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	April 8, 2013
Last Updated:	September 14, 2016
Health Authority:	Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Social Science Data Service

Keywords provided by 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

ClinicalTrials.gov processed this record on September 28, 2016