Efficacy Study of Fine Needle Technique on Calcific Tendinitis

This study is not yet open for participant recruitment.

Verified by Hadassah Medical Organization, November 2008

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00506038

Purpose

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:

Puncturing the calcium in the rotator cuff 15 times (the experiment group)
Puncturing the calcium in the rotator cuff twice (the controlled group)

Condition	Intervention	Phase
Tendinitis	Procedure: fine needle technique	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Phase 2 Study of the Fine Needle Technique on Calcific Tendinitis

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506038

Contacts

Contact: Ori Safran, MD

safran@inter.net.il

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:	Ori Safran, MD	Hadassah Medical Organization, Jerusalem, Israel
Study Chair:	Charles Milgrom, Prof.	Hadassah Medical Organization, Jerusalem, Israel

More Information

Study ID Numbers:	SAF01-HMO-CTIL
Study First Received:	July 24, 2007
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00506038
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

Calcific Tendinitis

Study placed in the following topic categories:

Tendinopathy
Tendon Injuries
Muscular Diseases

Musculoskeletal Diseases
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 16, 2009