Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

NCT01832376 | Completed DMC

• 1 other identifier: 2012/773
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Calcific Tendinitis

Keywords

Calcific tendinitis; Shoulder; Needle lavage; Ultrasound-guided

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of patients who need operative treatment during follow-up

  Baseline to 24 months

Other Outcomes (1)

• Size of the calcific deposit as determined on X-rays of the affected shoulder

  Baseline to 3 months and 24 months

Study Arms (1)

Ultrasound guided needle lavage

EXPERIMENTAL

Ultrasound guided needle lavage

Procedure: Ultrasound guided needle lavage

Interventions

Ultrasound guided needle lavage PROCEDURE

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.

Also known as: Barbotage

Ultrasound guided needle lavage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead

Study Sites (1)

Martina Hansens Hospital

Sandvika, 1306, Norway

Location

Related 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.

  RESULT

Related Links

• Study publication, open access

Study Officials

• Stefan Moosmayer, MD, PhD

  Martina Hansens Hospital, Sandvika, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 16, 2013
• Study Start: June 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

NO (1)