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Adhesive CapsulitisNCT00761943

Correlating Clinical Disease State With Color Doppler Ultrasound

An observational study of Adhesive Capsulitis, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Adhesive Capsulitis
How many people
30 participants
Where
1 siteUnited States
Study dates
Dec 2006to Dec 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Vanderbilt Orthopaedics and Rehabilitation

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: "Adhesive Capsulitis-Correlating Clinical Disease State With Color Doppler Ultrasound"

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.

Read the detailed description

Disease Prevalence:

Orthopaedic surgeons are frequently asked to evaluate patients with stiff and painful shoulders. Among the most common causes for such clinical condition is adhesive capsulitis (or frozen shoulder), which is thought to affect approximately 2-5% of the general population. The incidence in patients with diabetes is much higher, up to 29% in some studies.

Clinical Summary of Adhesive Capsulitis:

Adhesive Capsulitis may be summarized briefly as the clinical syndrome of shoulder pain and progressive loss of motion and eventual improvement of symptoms. The cause is classified as either primary (idiopathic) or secondary, if due to a known precipitating condition. Risk factors associated with developing adhesive capsulitis include diabetes, female sex, middle to older age, and thyroid disease. Secondary causes of adhesive capsulitis include trauma, shoulder surgery, degenerative arthritis, rotator cuff tears, or prolonged immobilization.

The condition is characterized functionally by loss of both active and passive range of motion and anatomically by thickening and contracture of the joint capsule. The term "Adhesive Capsulitis" was coined by Neviaser when he noted the contracted capsule peeled from the humeral head like "adhesive plaster from skin". A broader term "Frozen Shoulder" was used by Codman in 1934 to describe this and related conditions. There is a commonly accepted progression of three clinical phases: painful freezing, stiff/frozen phase, and eventually thawing with slow return of motion. Many patients will have some residual loss of motion for several years. For people with diabetes, residual, permanent loss of motion can be as much as 50%. The natural history of the disease has been shown to be more dismal than once thought.

Pathology of the Disease:

Histopathologic changes that occur in the joint capsule and synovial lining are cellular changes of chronic inflammation, fibrosis, perivascular infiltration in the subsynovial layer and increased vascularity. There is some debate as to whether the disease is primarily inflammatory or fibrotic in nature and there is support for both, depending on the stage of disease. Some have shown that arthroscopy reveals a highly vascular, red, inflamed synovium. Neviaser defined four stages of arthroscopic adhesive capsulitis ranging from acute synovitis to chronic adhesions. The pathology is not clearly understood and this makes optimal treatment more difficult to determine.

Limitations of Current Imaging Studies:

Imaging modalities commonly used to evaluate the shoulder such as x-ray (to rule out arthritic changes or fractures) are unremarkable in primary adhesive capsulitis. Traditional arthrograms or contrast Magnetic Resonance Imaging may show decreased capsular volume and edema but are invasive and expensive tests. Magnetic Resonance Arthrogram shows thickening of the coracohumeral ligament and the joint capsule in the area of the rotator interval. Although MRI can demonstrate edema and inflammatory changes, its cost seems prohibitive to follow clinical disease on a serial basis, perhaps monthly as the disease progresses. Ultrasound is a much more likely candidate for serial examination.

Successful Use of Ultrasound in Rheumatoid Wrist Studies:

Recent reports in the literature have shown color doppler ultrasound (CDUS) to be a promising tool for estimation of synovial inflammatory activity in rheumatoid arthritis. Researchers used specific quantitative criteria to measure the resistivity index of small blood vessels in the synovium and color pixel fraction. Both measures attempt to quantify vascularity as a surrogate indicator of inflammation in the joint capsule. In a subsequent study they injected the wrists with corticosteroid and then obtained ultrasound images one month later which showed changes in the resistivity index and color pixel fraction that correlated with the improved clinical evaluation and functional improvements.

Ultrasound in Adhesive Capsulitis:

Ultrasound study of the shoulder has many benefits over MRI/MRA including: no contraindications or risk to patients, non-invasive, and relatively low cos. Ultrasound is comparable to MRI in studying the synovium with much less downside. Despite is theoretical advantages; there are limited studies in the literature reporting on color doppler ultrasound to evaluate adhesive capsulitis of the shoulder. In one study, researchers correlated ultrasound findings with arthroscopic findings and concluded that ultrasound can provide an early, accurate diagnosis of adhesive capsulitis. Their criteria, however, were qualitative using echotexture and increased doppler flow to indicate increased vascularity. No quantitative measurements were made.

Clinical Importance of Proposed Study:

Although the objective in treating patients with adhesive capsulitis is clear (to restore full, pain-free motion and unrestricted shoulder function) the optimal treatment remains unclear. This is due in part because there is no clear consensus on diagnosis, poor understanding of the pathology, and difficulty comparing the effectiveness of treatment regimens. As in many poorly defined medical conditions, multiple, different empiric treatments are employed with varying success. If we could more clearly identify diagnostic criteria and reproducibly stage the disease we could then more reliably and scientifically compare treatment approaches and thus provide a real benefit to many patients with this common condition. Our proposed study is an important step in this process.

Keywords
Adhesive Capsulitis, Bursitis, Frozen Shoulder
Medical subject headings
Bursitis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (1)
  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2008 (estimated)
  2. Study startDec 2006
  3. Primary completionDec 2008
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00761943
Sponsor's protocol ID
061180
Status last verified
Apr 2017
First submitted
26 Sep 2008
Last updated
20 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 10509873
  • Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.

    PubMed 16356983
  • Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109.

    PubMed 10738419
  • 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.

    PubMed 14765452
  • 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.

    PubMed 15999280
  • Murnaghan JP. Frozen Shoulder, in Rockwood CA Jr, Matsen FA III (eds): The Shoulder. Philadelphia: WB Saunders, 1990, pp 837-62.

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

    PubMed 3441361
  • 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.

    PubMed 16352733
  • Shaffer B, Tibone JE, Kerlan RK. Frozen shoulder. A long-term follow-up. J Bone Joint Surg Am. 1992 Jun;74(5):738-46.

    PubMed 1624489
  • 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.

    PubMed 14616209
  • 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.

    PubMed 14583566
  • Warner JJ. Frozen Shoulder: Diagnosis and Management. J Am Acad Orthop Surg. 1997 May;5(3):130-140. doi: 10.5435/00124635-199705000-00002.

    PubMed 10797215

Questions about this trial

What is this clinical trial studying?

An observational study of Adhesive Capsulitis, run by Vanderbilt University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00761943, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.

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