Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica
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|ClinicalTrials.gov Identifier: NCT00847236|
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : August 23, 2017
|Condition or disease|
|Polymyalgia Rheumatica Rheumatoid Arthritis Rheumatic Disease|
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 :||Observational|
|Actual Enrollment :||142 participants|
|Official Title:||Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica|
|Actual Study Start Date :||January 2009|
|Primary Completion Date :||August 2013|
|Study Completion Date :||August 2013|
Subjects with Polymyalgia Rheumatica
50 subjects with Polymyalgia Rheumatica, both acute and chronic
Subjects w/o Polymyalgia Rheumatica
50 subjects with Rheumatic Disease other than polymyalgia Rheumatica
Subjects w/o Rheumatic Disease
50-Non Rheumatic disease subjects
- 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 ]
- Assessing the ease of measuring proximal arm tenderness [ Time Frame: One to two visits each subject ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847236
|United States, Massachusetts|
|Arlington, Massachusetts, United States, 02474|
|Principal Investigator:||Gerald S. Harris, M.D.||Lahey Clinic, Inc. Arlingtion|