Clinical trial NCT01832376: Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage
Official title: Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcific Tendinitis
Keywords: Calcific tendinitis
Shoulder
Needle lavage
Ultrasound-guided
Lead sponsor: Martina Hansen's Hospital
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: The self-report section of the American Shoulder and Elbow Surgeons score (ASES)
timeFrame: Baseline and 24 months
Secondary outcomes:
measure: Number of patients who need operative treatment during follow-up
timeFrame: Baseline to 24 months
Other outcomes:
measure: Size of the calcific deposit as determined on X-rays of the affected shoulder
timeFrame: Baseline to 3 months and 24 months
Locations:
city: Sandvika
country: Norway
facility: Martina Hansens Hospital
Study officials:
affiliation: Martina Hansens Hospital, Sandvika, Norway
name: Stefan Moosmayer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.