Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

Calcific Tendinitis Clinical Trial

Official title:

Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832376
• Other study ID #: 2012/773
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: May 2018

Study information

• Verified date: October 2018
• Source: Martina Hansen's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2018
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcific Tendinitis
• Tendinopathy

Intervention

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.

Locations

Country	Name	City	State
Norway	Martina Hansens Hospital	Sandvika

Sponsors (1)

Lead Sponsor	Collaborator
Martina Hansen's Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Moosmayer S and Aasen IB. Ultrasound- Guided Percutaneous Needle Treatment and Steroid Injection for Calcific Tendinopathy of the Shoulder: Can the Orthopedic Surgeon do it?. M J Orth. 3(1): 020, 2018.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Size of the calcific deposit as determined on X-rays of the affected shoulder	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	Baseline to 3 months and 24 months
Primary	The self-report section of the American Shoulder and Elbow Surgeons score (ASES)	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.	Baseline and 24 months
Secondary	Number of patients who need operative treatment during follow-up		Baseline to 24 months

External Links

•   Study publication, open access