Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

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

Study Overview

• Status: Completed
• Conditions: Calcific Tendinitis
• Intervention / Treatment: Procedure: Ultrasound guided needle lavage

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Sandvika, Norway, 1306
    • Martina Hansens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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 Names: Barbotage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of patients who need operative treatment during follow-up	Baseline to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Martina Hansen's Hospital
• Investigators: Principal Investigator: Stefan Moosmayer, MD, PhD, Martina Hansens Hospital, Sandvika, Norway

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study publication, open access

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: April 8, 2013
• First Submitted That Met QC Criteria: April 15, 2013
• First Posted (ESTIMATE): April 16, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Shoulder; Ultrasound-guided; Needle lavage; Calcific tendinitis
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: 2012/773