Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

Not Applicable

Completed

• Conditions: Calcific Tendinitis
• Interventions: Procedure: Ultrasound guided needle lavage

• Registration Number: NCT01832376
• Lead Sponsor: Martina Hansen's Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-16
• Primary Completion: 2016-02
• Study Completion: 2018-05
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-29
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound guided needle lavage	Ultrasound guided needle lavage	Ultrasound guided needle lavage

Primary Outcome Measures

Name	Time	Method
The self-report section of the American Shoulder and Elbow Surgeons score (ASES)	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients who need operative treatment during follow-up	Baseline to 24 months

Trial Locations

Locations (1)

Martina Hansens Hospital; 🇳🇴 Sandvika, Norway