Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- The self-report section of the American Shoulder and Elbow Surgeons score (ASES)
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Ultrasound guided needle lavage
Ultrasound guided needle lavage
Intervention: Ultrasound guided needle lavage (Procedure)
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)
Investigators
Stefan Moosmayer
MD, PhD
Martina Hansen's Hospital