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Trial record 34 of 132 for:    GCA

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00847236
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic

Tracking Information
First Submitted Date February 18, 2009
First Posted Date February 19, 2009
Last Update Posted Date August 23, 2017
Actual Study Start Date January 2009
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 18, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00847236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 18, 2009)
Assessing the ease of measuring proximal arm tenderness [ Time Frame: One to two visits each subject ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Outpatients and Healthy volunteers from colleague referral and own practice
Condition
  • Polymyalgia Rheumatica
  • Rheumatoid Arthritis
  • Rheumatic Disease
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 22, 2017)
142
Original Estimated Enrollment
 (submitted: February 18, 2009)
150
Actual Study Completion Date August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients signing Informed Consent

Exclusion Criteria:

  • Patients less than 50 years old
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00847236
Other Study ID Numbers 2008-078
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lahey Clinic
Study Sponsor Lahey Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Gerald S. Harris, M.D. Lahey Clinic, Inc. Arlingtion
PRS Account Lahey Clinic
Verification Date August 2017