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Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01832376
Enrollment
52
Registered
2013-04-16
Start date
2011-06-30
Completion date
2018-05-31
Last updated
2018-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcific Tendinitis

Keywords

Calcific tendinitis, Shoulder, Needle lavage, Ultrasound-guided

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

Interventions

PROCEDUREUltrasound guided needle lavage

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.

Sponsors

Vestre Viken Hospital Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
The self-report section of the American Shoulder and Elbow Surgeons score (ASES)Baseline and 24 monthsThe 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

MeasureTime frame
Number of patients who need operative treatment during follow-upBaseline to 24 months

Other

MeasureTime frameDescription
Size of the calcific deposit as determined on X-rays of the affected shoulderBaseline to 3 months and 24 monthsStandardized X-rays of the shoulder are taken at baseline, 3 and 24 month follow-up and the size of the calcific deposits will be measured and compared between examinations

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026