We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01832376
First Posted: April 16, 2013
Last Update Posted: September 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stefan Moosmayer, Martina Hansen's Hospital
  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: 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)

Resource links provided by NLM:


Further study details as provided by Stefan Moosmayer, 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 ]
    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


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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 Submitted: April 8, 2013
First Posted: April 16, 2013
Last Update Posted: September 15, 2016
Last Verified: September 2016

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