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Correlating Clinical Disease State With Color Doppler Ultrasound

This study has been completed.
Sponsor:
Collaborator:
Orthopaedic Research and Education Foundation
Information provided by (Responsible Party):
Rosemary A. Sanders, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00761943
First received: September 26, 2008
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  Purpose

We are trying to see if ultrasound is a good tool for looking at the changes that happen on the inside of the shoulder due frozen shoulder.


Condition
Adhesive Capsulitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: "Adhesive Capsulitis-Correlating Clinical Disease State With Color Doppler Ultrasound"

Resource links provided by NLM:

MedlinePlus related topics: Bursitis
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • To use color doppler ultrasound to grade inflammatory changes in the rotator interval of patients with adhesive capsulitis. [ Time Frame: Patients will be evaluated at each of their regularly scheduled clinic follow-up visits. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To use color doppler ultrasound to quantitatively measure inflammation of the joint capsule in subjects with adhesive capsulitis. Specific metrics that measure vascularity as a surrogate for inflammation will be used. [ Time Frame: Patients will be evaluated at each of their regularly scheduled clinic follow-up visits. ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2006
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients between the ages of 18 and 80 with Adhesive Capsulitis of the shoulder without previous shoulder surgery. Not including patients with secondary adhesive capsulitis related to trauma, surgery or other known cause.

Criteria

Inclusion Criteria:

  • Age range of 18 to 80.
  • Clinical diagnosis of Adhesive Capsulitis of the shoulder.

Exclusion Criteria:

  • Previous shoulder surgery.
  • Secondary Adhesive Capsulitis related to trauma, surgery or other known causes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761943

Locations
United States, Tennessee
Vanderbilt Orthopaedics and Rehabilitation
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Orthopaedic Research and Education Foundation
Investigators
Principal Investigator: Warren R. Dunn, M.D. Vanderbilt Orthopaedics and Rehabilitation
  More Information

Publications:
Murnaghan JP. Frozen Shoulder, in Rockwood CA Jr, Matsen FA III (eds): The Shoulder. Philadelphia: WB Saunders, 1990, pp 837-62.

Responsible Party: Rosemary A. Sanders, Research Coordinator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00761943     History of Changes
Other Study ID Numbers: 061180
Study First Received: September 26, 2008
Last Updated: October 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Adhesive Capsulitis
Bursitis
Frozen Shoulder

Additional relevant MeSH terms:
Bursitis
Periarthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis

ClinicalTrials.gov processed this record on May 21, 2013