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Sponsored by: |
Lahey Clinic |
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Information provided by: | Lahey Clinic |
ClinicalTrials.gov Identifier: | NCT00847236 |
The aim of this study is to evaluate a simple and rapid method in order to better define and treat Polymyalgia Rheumatica by measuring levels of muscle achiness and pain with a blood pressure cuff.
Condition |
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Polymyalgia Rheumatica Rheumatoid Arthritis Rheumatic Disease |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica |
Estimated Enrollment: | 150 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
50 subjects with Polymyalgia Rheumatica, both acute and chronic
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2
50 subjects with Rheumatic Disease other than polymyalgia Rheumatica
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3
50-Non Rheumatic disease subjects
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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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Outpatients and Healthy volunteers from colleague referral and own practice
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Lahey Arlington | Recruiting |
Arlington, Massachusetts, United States, 02474 | |
Contact: Gerald S. Harris, M.D. 781-641-0100 Gerald.S.Harris@Lahey.org | |
Contact: Elizabeth Learson, R.N. 781-641-0100 Elizabeth.Learson@Lahey.org |
Principal Investigator: | Gerald S. Harris, M.D. | Lahey Clinic, Inc. Arlingtion |
Responsible Party: | Lahey Clinic, Inc. ( Gerald S. Harris, M.D. ) |
Study ID Numbers: | 2008-078 |
Study First Received: | February 18, 2009 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00847236 History of Changes |
Health Authority: | United States: Institutional Review Board |
Polymyalgia Rheumatica Rheumatoid Arthritis Rheumatic Disease PMR |
Autoimmune Diseases Vasculitis Skin Diseases Joint Diseases Vascular Diseases Arthritis, Rheumatoid Central Nervous System Diseases Pain Rheumatic Diseases Brain Diseases Cerebrovascular Disorders |
Temporal Arteritis Hortons Disease Muscular Diseases Musculoskeletal Diseases Polymyalgia Rheumatica Giant Cell Arteritis Arthritis Connective Tissue Diseases Arteritis Autoimmune Diseases of the Nervous System |
Skin Diseases, Vascular Vasculitis Autoimmune Diseases Skin Diseases Immune System Diseases Joint Diseases Nervous System Diseases Vascular Diseases Arthritis, Rheumatoid Central Nervous System Diseases Rheumatic Diseases Vasculitis, Central Nervous System |
Brain Diseases Cerebrovascular Disorders Muscular Diseases Musculoskeletal Diseases Polymyalgia Rheumatica Giant Cell Arteritis Arthritis Connective Tissue Diseases Cardiovascular Diseases Arteritis Autoimmune Diseases of the Nervous System |