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Efficacy Study of Fine Needle Technique on Calcific Tendinitis

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00506038
First Posted: July 25, 2007
Last Update Posted: June 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  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:

  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)

Condition Intervention Phase
Tendinitis Procedure: fine needle technique Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Fine Needle Technique on Calcific Tendinitis

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 40
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506038


Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Ori Safran, MD Hadassah Medical Organization
Study Chair: Charles Milgrom, Prof. Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00506038     History of Changes
Other Study ID Numbers: SAF01-HMO-CTIL
First Submitted: July 24, 2007
First Posted: July 25, 2007
Last Update Posted: June 23, 2009
Last Verified: November 2008

Keywords provided by Hadassah Medical Organization:
Calcific Tendinitis

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries