Overview

This trial is active, not recruiting.

Condition calcific tendinitis
Treatment ultrasound guided needle lavage
Sponsor Martina Hansen's Hospital
Start date June 2011
End date February 2016
Trial size 50 participants
Trial identifier NCT01832376, 2012/773

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Ultrasound guided needle lavage
ultrasound guided needle lavage Barbotage
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.

Primary Outcomes

Measure
The self-report section of the American Shoulder and Elbow Surgeons score (ASES)
time frame: Baseline and 24 months

Secondary Outcomes

Measure
Number of patients who need operative treatment during follow-up
time frame: Baseline to 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage - a Multicenter, Randomized and Sham Controlled Study (KALK Study)
Principal investigator Stefan Moosmayer, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Martina Hansen's Hospital.