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Completed

NCT Number: NCT01832376

Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

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

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Key information

Conditions

Calcific Tendinitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Martina Hansens Hospital

Sandvika, 1306, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guided needle lavage

Procedure

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.

Other names: Barbotage

Primary outcomes

  1. 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

  1. Number of patients who need operative treatment during follow-up

    Time frame: Baseline to 24 months

Other outcomes

  1. Size of the calcific deposit as determined on X-rays of the affected shoulder

    Time frame: Baseline to 3 months and 24 months

    Standardized 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

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2018
First posted
Apr 16, 2013
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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