Efficacy Study of Fine Needle Technique on Calcific Tendinitis

Tendinitis Clinical Trial

Official title:

Phase 2 Study of the Fine Needle Technique on Calcific Tendinitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00506038
• Other study ID #: SAF01-HMO-CTIL
• Status: Terminated
• Phase: Phase 2
• First received: July 24, 2007
• Last updated: June 21, 2009

Study information

• Verified date: November 2008
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tendinitis

Intervention

Procedure:
• fine needle technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization