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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00847236
Enrollment
142
Registered
2009-02-19
Start date
2009-01-31
Completion date
2013-08-31
Last updated
2017-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polymyalgia Rheumatica, Rheumatic Disease, Rheumatoid Arthritis

Keywords

Polymyalgia Rheumatica, Rheumatoid Arthritis, Rheumatic Disease, PMR

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.

Interventions

None listed

Sponsors

Lahey Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients signing Informed Consent

Exclusion criteria

* Patients less than 50 years old

Design outcomes

Primary

MeasureTime frame
To define whether the measurement of proximal arm tenderness can be used to diagnose and treat patients with Polymyalgia RheumaticaOne to two visits each subject

Secondary

MeasureTime frame
Assessing the ease of measuring proximal arm tendernessOne to two visits each subject

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026