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Clinical Trials/NCT00506038
NCT00506038
Terminated
Phase 2

Phase 2 Study of the Fine Needle Technique on Calcific Tendinitis

Hadassah Medical Organization0 sites40 target enrollmentJuly 25, 2007
ConditionsTendinitis

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Tendinitis
Sponsor
Hadassah Medical Organization
Enrollment
40
Status
Terminated
Last Updated
16 years ago

Overview

Brief 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)
Registry
clinicaltrials.gov
Start Date
July 25, 2007
End Date
TBD
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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
  • Coagulation System impairments

Outcomes

Primary Outcomes

Not specified

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