Pain Quality Study

Low Back Pain Clinical Trial

Official title:

Pain Quality in Individuals With Low Back Pain, Headache, and Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321190
• Other study ID #: 40324-EA
• Status: Completed
• Start date: June 2011
• Est. completion date: April 2013

Study information

• Verified date: October 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: April 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Fibromyalgia
• Headache
• Low Back Pain
• Myofascial Pain Syndromes

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Jensen MP, Johnson LE, Gertz KJ, Galer BS, Gammaitoni AR. The words patients use to describe chronic pain: implications for measuring pain quality. Pain. 2013 Dec;154(12):2722-8. doi: 10.1016/j.pain.2013.08.003. Epub 2013 Aug 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Quality Assessment Scale	Assesses qualities (e.g. hot,cold) of pain	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.