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

NCT ID: NCT00847236

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 142 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-08-31

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.

Conditions

Polymyalgia Rheumatica; Rheumatoid Arthritis; Rheumatic Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects with Polymyalgia Rheumatica

50 subjects with Polymyalgia Rheumatica, both acute and chronic

No interventions assigned to this group

Subjects w/o Polymyalgia Rheumatica

50 subjects with Rheumatic Disease other than polymyalgia Rheumatica

No interventions assigned to this group

Subjects w/o Rheumatic Disease

50-Non Rheumatic disease subjects

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients signing Informed Consent

Exclusion Criteria

• Patients less than 50 years old

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lahey Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerald S. Harris, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lahey Clinic, Inc. Arlingtion

Locations

Lahey Arlington

Arlington, Massachusetts, United States

Countries

United States

Other Identifiers

2008-078

Identifier Type: -

Identifier Source: org_study_id