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Clinical Trials/NCT00506038
NCT00506038TerminatedPhase 2

Phase 2 Study of the Fine Needle Technique on Calcific Tendinitis

Hadassah Medical Organization0 sites40 target enrollmentStarted: July 25, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
40
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study 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)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Other

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