UnknownNot Applicable

Ultrasound Guided Needling Versus Ultrasound Guided Corticosteroid Injection Alone, a Randomized Controlled Trial.

Netherlands80 participantsStarted 2012-07

Plain-language summary

Ultrasound guided needling is becoming an accepted treatment for patients with shoulder pain due to calcifying tendinitis. However, evidence for this treatment is lacking. The investigators expect that patients treated with us guided needling with corticosteroid injection compared with patients treated with only corticosteroid injections in the subacromial bursa have better clinical outcome after one year follow-up.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Shoulder pain without improvement after 3 months despite conservative treatment * Calcification on x-ray (Gartner type I of II) and ultrasound in the supraspinatus tendon less than 6 weeks before the treatment * All patients are first seen and included by the orthopaedic surgeon Exclusion Criteria: * Previous operation of the shoulder * Previous ultrasound guided needling of the shoulder * Frozen shoulder * Last corticosteroid injection less than 3 months ago * Comorbidities of the painful shoulder on x-ray or ultrasound ( ruptured tendon, fracture, bursitis,...) * No informed consent * Pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

VAS score on long term

Timeframe: 1 year

Constant score on long term

Timeframe: 1 year

Trial details

NCT IDNCT01538758

SponsorMedisch Spectrum Twente

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-07

Contact for this trial

Eva Genbrugge, MD

+31 53 4 87 20 00 eva_genbrugge@hotmail.com

View on ClinicalTrials.gov More Calcific Tendinitis trials