Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica

Rheumatoid Arthritis Clinical Trial

Official title:

Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847236
• Other study ID #: 2008-078
• Status: Completed
• Phase: N/A
• First received: February 18, 2009
• Last updated: August 22, 2017
• Start date: January 2009
• Est. completion date: August 2013

Study information

• Verified date: August 2017
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Patients signing Informed Consent

Exclusion Criteria:

• Patients less than 50 years old

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Collagen Diseases
• Giant Cell Arteritis
• Polymyalgia Rheumatica
• Rheumatic Disease
• Rheumatic Diseases
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Lahey Arlington	Arlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define whether the measurement of proximal arm tenderness can be used to diagnose and treat patients with Polymyalgia Rheumatica		One to two visits each subject
Secondary	Assessing the ease of measuring proximal arm tenderness		One to two visits each subject