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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
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Calcium
U.S. FDA Resources

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
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
Calcinosis
Muscular Diseases
Musculoskeletal Diseases
 Tendon Injuries
Wounds and Injuries
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013