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.
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
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.
- Conditions
- Adhesive Capsulitis
- 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.
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)
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.
- First posted30 Sep 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation
- Responsible party
- Principal investigator, Rosemary A. Sanders, Vanderbilt University
- Investigators
- Warren R. Dunn, M.D., Principal investigator, Vanderbilt Orthopaedics and Rehabilitation
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 10509873Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.
PubMed 16356983Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109.
PubMed 10738419Kordella 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 14765452Lee 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 15999280Murnaghan 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 3441361Papatheodorou 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 16352733Shaffer B, Tibone JE, Kerlan RK. Frozen shoulder. A long-term follow-up. J Bone Joint Surg Am. 1992 Jun;74(5):738-46.
PubMed 1624489Terslev 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 14616209Terslev 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 14583566Warner 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Adhesive Capsulitis-Correlating Clinical Disease State With Color Doppler Ultrasound"
- ClinicalTrials.gov ID
- NCT00761943
- Acronym / sponsor ID
- 061180
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive Capsulitis, Bursitis, Frozen Shoulder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation
- Study start
- Dec 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Age range of 18 to 80.
- Clinical diagnosis of Adhesive Capsulitis of the shoulder.
Key exclusion criteria (2 listed)
- Previous shoulder surgery.
- Secondary Adhesive Capsulitis related to trauma, surgery or other known causes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Background: PubMed 10509873Balci 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.
- Background: PubMed 16356983Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.
- Background: PubMed 10738419Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109.
- Background: PubMed 14765452Kordella 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.
- Background: PubMed 15999280Lee 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.
- BackgroundMurnaghan JP. Frozen Shoulder, in Rockwood CA Jr, Matsen FA III (eds): The Shoulder. Philadelphia: WB Saunders, 1990, pp 837-62.
- Background: PubMed 3441361Neviaser TJ. Arthroscopy of the shoulder. Orthop Clin North Am. 1987 Jul;18(3):361-72.
- Background: PubMed 16352733Papatheodorou 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.
- Background: PubMed 1624489Shaffer B, Tibone JE, Kerlan RK. Frozen shoulder. A long-term follow-up. J Bone Joint Surg Am. 1992 Jun;74(5):738-46.
- Background: PubMed 14616209Terslev 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.
- Background: PubMed 14583566Terslev 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.
- Background: PubMed 10797215Warner JJ. Frozen Shoulder: Diagnosis and Management. J Am Acad Orthop Surg. 1997 May;5(3):130-140. doi: 10.5435/00124635-199705000-00002.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren R. Dunn, M.D. principal investigator
Vanderbilt Orthopaedics and Rehabilitation
1 site in 1 country: see every site and its status.
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.