Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica
|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 ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847236
|United States, Massachusetts|
|Arlington, Massachusetts, United States, 02474|
|Principal Investigator:||Gerald S. Harris, M.D.||Lahey Clinic, Inc. Arlingtion|