Clinical trial NCT00847236: Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica
Official title: Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polymyalgia Rheumatica
Rheumatoid Arthritis
Rheumatic Disease
Keywords: Polymyalgia Rheumatica
Rheumatoid Arthritis
Rheumatic Disease
PMR
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 142
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients and Healthy volunteers from colleague referral and own practice

Brief summary: 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.

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 criteria: Inclusion Criteria:

* Patients signing Informed Consent

Exclusion Criteria:

* Patients less than 50 years old

Primary outcomes:
measure: To define whether the measurement of proximal arm tenderness can be used to diagnose and treat patients with Polymyalgia Rheumatica
timeFrame: One to two visits each subject
Secondary outcomes:
measure: Assessing the ease of measuring proximal arm tenderness
timeFrame: One to two visits each subject
Other outcomes:
Locations:
city: Arlington
country: United States
facility: Lahey Arlington
state: Massachusetts
Study officials:
affiliation: Lahey Clinic, Inc. Arlingtion
name: Gerald S. Harris, M.D.
role: PRINCIPAL_INVESTIGATOR
References: