- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00847236
Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica
Study Overview
Status
Detailed Description
This study is being conducted to evaluate a method for the quantifying of the proximal tenderness in patients with presumed diagnosis of Polymyalgia Rheumatica(PMR)using the measurements of pain thresholds(in both upper and lower arms) by the use of a standard blood pressure cuff.
At the present time the diagnosis of PMR is based upon four classic criteria, History of sudden onset symmetric painful proximal myopathy, Physical demonstrating proximal tenderness without loss of motion passively, Laboratory evidence of significant inflammation: ESR>50 and treatment with a rapidly beneficial response to low dose prednisone.
While the history, laboratory findings, and the response to prednisone are easily documented, the complaint of tenderness and the physical response to that tenderness is difficult to define and quantitate.
By better quantifying the tenderness and the physical response to that tenderness will, it is hoped, lead to more rapid diagnosis as well as improved approach to treatment.
Three groups of patients will be studied. Each patient, after written informed consent and procedure statement, will have pain threshold measurements taken and recorded by standard blood pressure cuff 4 times: one each on the lower and upper arms. The blood pressure cuff will be inflated to the level of maximum pain, then deflated, recording the maximum pain level. Absolute numbers will be used for each measurement. Blood pressure will not be recorded.
This study is an attempt to add definition to the diagnosis of Polymyalgia Rheumatica with a both simple and rapid office exam.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Arlington, Massachusetts, United States, 02474
- Lahey Arlington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients signing Informed Consent
Exclusion Criteria:
- Patients less than 50 years old
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Subjects with Polymyalgia Rheumatica
50 subjects with Polymyalgia Rheumatica, both acute and chronic
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Subjects w/o Polymyalgia Rheumatica
50 subjects with Rheumatic Disease other than polymyalgia Rheumatica
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Subjects w/o Rheumatic Disease
50-Non Rheumatic disease subjects
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To define whether the measurement of proximal arm tenderness can be used to diagnose and treat patients with Polymyalgia Rheumatica
Time Frame: One to two visits each subject
|
One to two visits each subject
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessing the ease of measuring proximal arm tenderness
Time Frame: One to two visits each subject
|
One to two visits each subject
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerald S. Harris, M.D., Lahey Clinic, Inc. Arlingtion
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Muscular Diseases
- Vasculitis
- Skin Diseases, Vascular
- Vasculitis, Central Nervous System
- Arteritis
- Arthritis
- Arthritis, Rheumatoid
- Rheumatic Diseases
- Collagen Diseases
- Polymyalgia Rheumatica
- Giant Cell Arteritis
Other Study ID Numbers
- 2008-078
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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