Low Back PainNCT01321190
Pain Quality Study
An observational study of Low Back Pain and Headache, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Headache, Fibromyalgia
- How many people
- 307 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Individuals would be excluded if they have more than one of the three pain diagnoses to be studied.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Quality in Individuals With Low Back Pain, Headache, and Fibromyalgia
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.
- Conditions
- Low Back Pain, Headache, Fibromyalgia
- Medical subject headings
- Low Back Pain, Headache, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low Back Pain | Individuals who experience bothersome low back pain. | |
| Headache | Individuals who experience bothersome headaches. | |
| Fibromyalgia | Individuals who experience bothersome fibromyalgia-related pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Quality Assessment Scale
Assesses qualities (e.g. hot,cold) of pain
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Mark Jensen, University of Washington
- Investigators
- Mark P Jensen, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321190
- Sponsor's protocol ID
- 40324-EA
- Status last verified
- Oct 2018
- First submitted
- 21 Mar 2011
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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):2722-2728. doi: 10.1016/j.pain.2013.08.003. Epub 2013 Aug 8.
PubMed 23933183
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Quality in Individuals With Low Back Pain, Headache, and Fibromyalgia
- ClinicalTrials.gov ID
- NCT01321190
- Acronym / sponsor ID
- 40324-EA
- Conditions
- Low Back Pain, Headache, Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Back Pain | – | –Individuals who experience bothersome low back pain. |
| Headache | – | –Individuals who experience bothersome headaches. |
| Fibromyalgia | – | –Individuals who experience bothersome fibromyalgia-related pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals would be excluded if they have more than one of the three pain diagnoses to be studied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Results publication: PubMed 23933183Jensen 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):2722-2728. doi: 10.1016/j.pain.2013.08.003. Epub 2013 Aug 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark P Jensen, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Headache, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01321190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.