Pain Quality Study

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. Identifier: NCT01321190
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : October 17, 2018
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Mark Jensen, University of Washington

Brief Summary:
One way to better understand how various treatments for pain differ is to determine the effects of these treatments on different pain qualities or characteristics. For example, pain can be described as "hot", "electrical", "cold", "achy", and "piercing." In order to determine which pain quality/qualities that a pain treatment affects, researchers must develop measures of these pain qualities or characteristics. The purpose of this study is to learn more about the different pain qualities individuals who have low back pain, headaches and fibromyalgia experience. Identifying the common qualities of pain experienced by these groups will help researchers evaluate and develop more comprehensive pain quality measures, which will ultimately help them to be able to test the effectiveness of treatments for these different pain qualities.

Condition or disease
Low Back Pain Headache Fibromyalgia

Study Type : Observational
Actual Enrollment : 307 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pain Quality in Individuals With Low Back Pain, Headache, and Fibromyalgia
Study Start Date : June 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Low Back Pain
Individuals who experience bothersome low back pain.
Individuals who experience bothersome headaches.
Individuals who experience bothersome fibromyalgia-related pain.

Primary Outcome Measures :
  1. Pain Quality Assessment Scale [ Time Frame: The assessment scale was administered once within a month following enrollment in the study; the assessment scale was not administered within a timeframe specific to an event or onset of condition. ]
    Assesses qualities (e.g. hot,cold) of pain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals who have a formal diagnosis of one of the three conditions studied and have received services at either or both the Harborview Medical Center and the University of Washington Medical Center.

Inclusion Criteria:

  • Speaks and understands English;
  • At least 18 years of age;
  • Confirms a diagnosis from a physician or certified medical provider of one of the three medical conditions (low back pain, headache, fibromyalgia), and that pain related to this diagnosis is still bothersome.
  • Has experienced bothersome pain associated with their diagnosis in the past three months of a sufficient intensity;
  • English is their first and primary language.

Exclusion Criteria:

  • Individuals would be excluded if they have more than one of the three pain diagnoses to be studied.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01321190

United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Merck Sharp & Dohme Corp.
Principal Investigator: Mark P Jensen, PhD University of Washington

Publications of Results:
Responsible Party: Mark Jensen, Principal Investigator, University of Washington Identifier: NCT01321190     History of Changes
Other Study ID Numbers: 40324-EA
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases