NCT00761943

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

September 26, 2008

Last Update Submit

April 19, 2017

Conditions

Adhesive Capsulitis

Keywords

Adhesive CapsulitisBursitisFrozen Shoulder

Outcome Measures

Primary Outcomes (1)

  • To use color doppler ultrasound to grade inflammatory changes in the rotator interval of patients with adhesive capsulitis.

    Patients will be evaluated at each of their regularly scheduled clinic follow-up visits.

Secondary Outcomes (1)

  • 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.

    Patients will be evaluated at each of their regularly scheduled clinic follow-up visits.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Previous shoulder surgery.
  • Secondary Adhesive Capsulitis related to trauma, surgery or other known causes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Orthopaedics and Rehabilitation

Nashville, Tennessee, 37232, United States

Location

Related Publications (12)

  • Balci N, Balci MK, Tuzuner 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. doi: 10.1016/s1056-8727(99)00037-9.

    PMID: 10509873BACKGROUND

  • Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.

    PMID: 16356983BACKGROUND

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

    PMID: 10738419BACKGROUND

  • 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.

    PMID: 14765452BACKGROUND

  • 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. doi: 10.1007/s00256-005-0957-0. Epub 2005 Jul 6.

    PMID: 15999280BACKGROUND

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

    BACKGROUND

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

    PMID: 3441361BACKGROUND

  • 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. doi: 10.1148/rg.e23.

    PMID: 16352733BACKGROUND

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

    PMID: 1624489BACKGROUND

  • 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. doi: 10.1080/02841850312331287759.

    PMID: 14616209BACKGROUND

  • 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. doi: 10.1136/ard.62.11.1049.

    PMID: 14583566BACKGROUND

  • Warner JJ. Frozen Shoulder: Diagnosis and Management. J Am Acad Orthop Surg. 1997 May;5(3):130-140. doi: 10.5435/00124635-199705000-00002.

    PMID: 10797215BACKGROUND

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Warren R. Dunn, M.D.

    Vanderbilt Orthopaedics and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

December 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations

US(1)