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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00847236
First received: February 18, 2009
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition
Polymyalgia Rheumatica
Rheumatoid Arthritis
Rheumatic Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica

Resource links provided by NLM:


Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Assessing the ease of measuring proximal arm tenderness [ Time Frame: One to two visits each subject ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Outpatients and Healthy volunteers from colleague referral and own practice

Criteria

Inclusion Criteria:

  • Patients signing Informed Consent

Exclusion Criteria:

  • Patients less than 50 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847236

Locations
United States, Massachusetts
Lahey Arlington
Arlington, Massachusetts, United States, 02474
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Gerald S. Harris, M.D. Lahey Clinic, Inc. Arlingtion
  More Information

No publications provided

Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00847236     History of Changes
Other Study ID Numbers: 2008-078
Study First Received: February 18, 2009
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Polymyalgia Rheumatica
Rheumatoid Arthritis
Rheumatic Disease
PMR

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Polymyalgia Rheumatica
Giant Cell Arteritis
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Arteritis
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Skin Diseases, Vascular
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014