Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica
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Purpose
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: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica |
- 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 ] [ Designated as safety issue: No ]
- Assessing the ease of measuring proximal arm tenderness [ Time Frame: One to two visits each subject ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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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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.
Eligibility| 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:
- Patients signing Informed Consent
Exclusion Criteria:
- Patients less than 50 years old
Contacts and Locations| United States, Massachusetts | |
| Lahey Arlington | |
| Arlington, Massachusetts, United States, 02474 | |
| Principal Investigator: | Gerald S. Harris, M.D. | Lahey Clinic, Inc. Arlingtion |
More Information
No publications provided
| Responsible Party: | Lahey Clinic |
| ClinicalTrials.gov Identifier: | NCT00847236 History of Changes |
| Other Study ID Numbers: | 2008-078 |
| Study First Received: | February 18, 2009 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Lahey Clinic:
|
Polymyalgia Rheumatica Rheumatoid Arthritis Rheumatic Disease PMR |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Polymyalgia Rheumatica Giant Cell Arteritis Rheumatic Diseases Joint Diseases Musculoskeletal Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Muscular Diseases Vasculitis, Central Nervous System |
Autoimmune Diseases of the Nervous System Nervous System Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Arteritis Vascular Diseases Cardiovascular Diseases Vasculitis Skin Diseases, Vascular Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013