search
Back to results

Efficacy Study of Fine Needle Technique on Calcific Tendinitis

Primary Purpose

Tendinitis

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
fine needle technique
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinitis focused on measuring Calcific Tendinitis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2007
    Last Updated
    June 21, 2009
    Sponsor
    Hadassah Medical Organization
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00506038
    Brief Title
    Efficacy Study of Fine Needle Technique on Calcific Tendinitis
    Official Title
    Phase 2 Study of the Fine Needle Technique on Calcific Tendinitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2008
    Overall Recruitment Status
    Terminated
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

    5. Study Description

    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: Puncturing the calcium in the rotator cuff 15 times (the experiment group) Puncturing the calcium in the rotator cuff twice (the controlled group)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tendinitis
    Keywords
    Calcific Tendinitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    fine needle technique

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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 Pregnancy Coagulation System impairments
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ori Safran, MD
    Organizational Affiliation
    Hadassah Medical Organization
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Charles Milgrom, Prof.
    Organizational Affiliation
    Hadassah Medical Organization
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy Study of Fine Needle Technique on Calcific Tendinitis

    We'll reach out to this number within 24 hrs