Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage
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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) |
- 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.
- Number of patients who need operative treatment during follow-up [ Time Frame: Baseline to 24 months ]
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Norway | |
| Martina Hansens Hospital | |
| Sandvika, Norway, 1306 | |
| 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 |