Efficacy Study of Fine Needle Technique on Calcific Tendinitis

Phase 2

Terminated

• Conditions: Tendinitis

• Registration Number: NCT00506038
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Background: Calcific tendinitis of the rotator cuff may cause chronic pain at the shoulder. Sometimes the pain can lead to a serious impairment in the daily life.

One of the most efficient treatments is percutaneous needle aspiration using ultrasound guidance.

This treatment includes identification the tendonitis with US or screening , local anesthesia and then puncturing the calcium in the rotator cuff many times. The treatment is short 5-10 minutes, relatively cheap ,safe and usually with good outcomes. However in the literature there is a lack of controlled prospective trials.

Our goal is to set a study that will evaluate this treatment between two groups:

1. Puncturing the calcium in the rotator cuff 15 times (the experiment group)

2. Puncturing the calcium in the rotator cuff twice (the controlled group)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-24
• Study First Submitted QC: 2007-07-24
• Study First Posted: 2007-07-25
• Status Verified: 2008-11
• Last Update Submitted: 2009-06-21
• Last Update Posted: 2009-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 18 and above.
2. 6 months of pain in the shoulder.
3. Positive IMPING and sensitivity on SST.
4. Calcification above 1 cm in one of the dimensions by US or aray of the shoulder.
5. Completed conservative treatment: physiotherapy or analgesics.

Exclusion Criteria

1. Diabetes, Nephrological diseases
2. RC tear according to US.
3. Prior operation in this shoulder
4. Steroids injection in the last three months.
5. A patient that is in the absorption phase of the tendinitis
6. Pregnancy
7. Coagulation System impairments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL