Correlating Clinical Disease State With Color Doppler Ultrasound - Full Text View

Sponsors and Collaborators:	Vanderbilt University Orthopaedic Research and Education Foundation
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00761943

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

MedlinePlus related topics: Bursitis Ultrasound

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	50
Study Start Date:	December 2006
Estimated Study Completion Date:	March 2009
Estimated 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

Contacts

Contact: Ryan L. Hartman, M.D.	615-936-0100	Ryan.Hartman@vanderbilt.edu
Contact: Brooke E. Rode, BA	615-936-1357	Brooke.E.Rode@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt Orthopaedics and Rehabilitation	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Ryan L. Hartman, M.D. 615-936-0100 Ryan.Hartman@vanderbilt.edu
Contact: Brooke E. Rode, BA 615-936-1357 Brooke.E.Rode@vanderbilt.edu
Principal Investigator: John E. Kuhn, M.D.
Principal Investigator: Ryan L. Hartman, M.D.
Sub-Investigator: Warren R. Dunn, M.D.

Sponsors and Collaborators

Vanderbilt University

Orthopaedic Research and Education Foundation

Investigators

Principal Investigator:

Ryan L. Hartman, M.D.

Vanderbilt Orthopaedics and Rehabilitation

More Information

Publications:

Balci N, Balci MK, Tüzüner S. Shoulder adhesive capsulitis and shoulder range of motion in type II diabetes mellitus: association with diabetic complications. J Diabetes Complications. 1999 May-Jun;13(3):135-40.

Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. Review. No abstract available.

Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109. Review.

Kordella T. Frozen shoulder & diabetes. Frozen shoulder affects 20 percent of people with diabetes. Proper treatment can help you work through it. Diabetes Forecast. 2002 Aug;55(8):60-4. No abstract available.

Lee JC, Sykes C, Saifuddin A, Connell D. Adhesive capsulitis: sonographic changes in the rotator cuff interval with arthroscopic correlation. Skeletal Radiol. 2005 Sep;34(9):522-7. Epub 2005 Jul 6.

Neviaser TJ. Arthroscopy of the shoulder. Orthop Clin North Am. 1987 Jul;18(3):361-72.

Papatheodorou A, Ellinas P, Takis F, Tsanis A, Maris I, Batakis N. US of the shoulder: rotator cuff and non-rotator cuff disorders. Radiographics. 2006 Jan-Feb;26(1):e23. Review.

Shaffer B, Tibone JE, Kerlan RK. Frozen shoulder. A long-term follow-up. J Bone Joint Surg Am. 1992 Jun;74(5):738-46.

Terslev L, Torp-Pedersen S, Qvistgaard E, Bliddal H. Spectral Doppler and resistive index. A promising tool in ultrasonographic evaluation of inflammation in rheumatoid arthritis. Acta Radiol. 2003 Nov;44(6):645-52.

Terslev L, Torp-Pedersen S, Qvistgaard E, Danneskiold-Samsoe B, Bliddal H. Estimation of inflammation by Doppler ultrasound: quantitative changes after intra-articular treatment in rheumatoid arthritis. Ann Rheum Dis. 2003 Nov;62(11):1049-53.

Warner JJ. Frozen Shoulder: Diagnosis and Management. J Am Acad Orthop Surg. 1997 May;5(3):130-140.

Responsible Party:	Vanderbilt Orthopaedics and Rehabilitation ( Ryan L. Hartman, MD )
Study ID Numbers:	061180
Study First Received:	September 26, 2008
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00761943
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Adhesive Capsulitis
Bursitis
Frozen Shoulder

Study placed in the following topic categories:

Musculoskeletal Diseases
Joint Diseases
Bursitis

ClinicalTrials.gov processed this record on January 14, 2009