Efficacy Study of Fine Needle Technique on Calcific Tendinitis

This study has been terminated.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00506038
First received: July 24, 2007
Last updated: June 21, 2009
Last verified: November 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00506038     History of Changes
Other Study ID Numbers: SAF01-HMO-CTIL
Study First Received: July 24, 2007
Last Updated: June 21, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Calcific Tendinitis

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

ClinicalTrials.gov processed this record on August 28, 2014