Chronic Low Back PainNCT04060953
Quality of Life in Managing Chronic Pain
A study testing Health-Related Quality of Life Report in people with Chronic Low Back Pain, run by University of North Texas Health Science Center at 1 site in United States.
Trial summary
This study evaluates the use of a health-related quality of life report based on the SPADE cluster (sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue) derived from the PROMIS-29 instrument in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Health-Related Quality of Life Report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2019to 14 Jan 2020
- Phase
- Interventional
- 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 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Low Back Pain based on criteria established by the NIH Task Force on Research Standards for Chronic Low Back Pain AND SPADE Cluster Score ≥ 55
Who cannot join
- Absence of Chronic Low Back Pain OR SPADE Cluster Score < 55
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Texas Health Science Center
Fort Worth, Texas, 76107
About this study
Official title: Health-Related Quality of Life Measures to Optimize Chronic Pain Management
This study evaluates the use of a health-related quality of life report based on the SPADE cluster (sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue) derived from the PROMIS-29 instrument in patients with chronic low back pain. Half of the participants will receive the report, while the other half will not.
Read the detailed description
The health-related quality of life report provides participants with an overall score on the SPADE cluster and scores on each of its five component scales. The recently released Federal Pain Research Strategy states that pain cannot be measured in isolation, but rather should be assessed in conjunction with other outcome measures in 'non-pain domains,' such as quality of life. It recognizes that pain may be affected by, and affect, such patient attributes as sleep, mood, cognition, function, and quality of life. Further, the report states that improvement in pain without concomitant improvement in other domains may not constitute a clinically meaningful outcome. This study aims to assess the utility of a health-related quality of life report in improving quality of life, back pain intensity, and back-related disability in participants with chronic low back pain.
- Conditions
- Chronic Low Back Pain
- Being tested
- Health-Related Quality of Life Report
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-Related Quality of Life ReportOther
Subject report and interpretation guide based on SPADE cluster scores
| Study group | Role | What they receive |
|---|---|---|
| Health-Related Quality of Life Report | Experimental | Participants randomized to this arm will receive the Health-Related Quality of Life Report. Receives: Other: Health-Related Quality of Life Report |
| Wait List to Receive the Report | No intervention | Participants randomized to this arm will receive the Health-Related Quality of Life Report following completion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS-29 Quality of Life Measures
SPADE Cluster Score (acronym represents Sleep Disturbance, Pain Interference, Anxiety, Depression, and Low Energy/Fatigue subscales derived from the PROMIS-29). Each raw subscale score ranges from 4 to 20. Each subscale raw score is then converted to a population-normed "t-score," with a mean of 50 and standard deviation of 10. The SPADE Cluster Score is then computed as the mean of these five subscale t-scores. Higher t-scores on the SPADE Cluster and each of its component scales represent worse outcomes.
Measured: 3 Months Post-Randomization
Secondary outcomes (2)
Low Back Pain Intensity
Numerical Rating Scale for Pain (0-10).
Measured: 3 Months Post-Randomization
Back-Related Disability
Roland-Morris Disability Questionnaire (0-24).
Measured: 3 Months Post-Randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start16 Aug 2019
- Primary completion14 Jan 2020
- Study completion14 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John C. Licciardone, D.O., M.S., M.B.A., University of North Texas Health Science Center
- Investigators
- John C Licciardone, DO, Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060953
- Sponsor's protocol ID
- 300690
- Status last verified
- Feb 2020
- First submitted
- 16 Aug 2019
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life Measures to Optimize Chronic Pain Management
- ClinicalTrials.gov ID
- NCT04060953
- Acronym / sponsor ID
- 300690
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Study start
- 16 Aug 2019 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 19 Aug 2019 (actual)
- 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.
This study evaluates the use of a health-related quality of life report based on the SPADE cluster (sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue) derived from the PROMIS-29 instrument in patients with chronic low back pain. Half of the participants will receive the report, while the other half will not.
Detailed description
The health-related quality of life report provides participants with an overall score on the SPADE cluster and scores on each of its five component scales. The recently released Federal Pain Research Strategy states that pain cannot be measured in isolation, but rather should be assessed in conjunction with other outcome measures in 'non-pain domains,' such as quality of life. It recognizes that pain may be affected by, and affect, such patient attributes as sleep, mood, cognition, function, and quality of life. Further, the report states that improvement in pain without concomitant improvement in other domains may not constitute a clinically meaningful outcome. This study aims to assess the utility of a health-related quality of life report in improving quality of life, back pain intensity, and back-related disability in participants with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health-Related Quality of Life Report | Experimental | Other: Health-Related Quality of Life ReportParticipants randomized to this arm will receive the Health-Related Quality of Life Report. |
| Wait List to Receive the Report | No intervention | –Participants randomized to this arm will receive the Health-Related Quality of Life Report following completion of the study. |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic Low Back Pain based on criteria established by the NIH Task Force on Research Standards for Chronic Low Back Pain AND SPADE Cluster Score ≥ 55
Key exclusion criteria (1 listed)
- Absence of Chronic Low Back Pain OR SPADE Cluster Score < 55
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health-Related Quality of Life ReportSubject report and interpretation guide based on SPADE cluster scores | Other | Health-Related Quality of Life Report |
Primary outcome
PROMIS-29 Quality of Life Measures
Time frame: 3 Months Post-Randomization
SPADE Cluster Score (acronym represents Sleep Disturbance, Pain Interference, Anxiety, Depression, and Low Energy/Fatigue subscales derived from the PROMIS-29). Each raw subscale score ranges from 4 to 20. Each subscale raw score is then converted to a population-normed "t-score," with a mean of 50 and standard deviation of 10. The SPADE Cluster Score is then computed as the mean of these five subscale t-scores. Higher t-scores on the SPADE Cluster and each of its component scales represent worse outcomes.
2 secondary outcomes
Low Back Pain Intensity
Time frame: 3 Months Post-Randomization
Back-Related Disability
Time frame: 3 Months Post-Randomization
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 26 Feb 2020.
- Individual participant dataSharing planned: No
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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.
John C Licciardone, DO principal investigator
University of North Texas Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health-Related Quality of Life Report in people with Chronic Low Back Pain, run by University of North Texas Health Science Center 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 1 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 26 Feb 2020. 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?
PROMIS-29 Quality of Life Measures (time frame: 3 Months Post-Randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2020.