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Clinical Trials/NCT01832376
NCT01832376
Completed
Not Applicable

Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

Martina Hansen's Hospital1 site in 1 country52 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Calcific Tendinitis
Sponsor
Martina Hansen's Hospital
Enrollment
52
Locations
1
Primary Endpoint
The self-report section of the American Shoulder and Elbow Surgeons score (ASES)
Status
Completed
Last Updated
7 years ago

Overview

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
Registry
clinicaltrials.gov
Start Date
June 2011
End Date
May 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Martina Hansen's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Stefan Moosmayer

MD, PhD

Martina Hansen's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Number of patients who need operative treatment during follow-up(Baseline to 24 months)

Study Sites (1)

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