NCT00506038

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. 1.Puncturing the calcium in the rotator cuff 15 times (the experiment group)
  2. 2.Puncturing the calcium in the rotator cuff twice (the controlled group)

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
Last Updated

June 23, 2009

Status Verified

November 1, 2008

First QC Date

July 24, 2007

Last Update Submit

June 21, 2009

Conditions

Tendinitis

Keywords

Calcific Tendinitis

Interventions

fine needle techniquePROCEDURE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and above.
  • 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.

You may not qualify if:

  • 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
  • Pregnancy
  • Coagulation System impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Study Officials

  • Ori Safran, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

  • Charles Milgrom, Prof.

    Hadassah Medical Organization

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2007

First Posted

July 25, 2007

Last Updated

June 23, 2009

Record last verified: 2008-11