Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Back Pain, Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 25 - 65 |
| Updated: | 7/7/2017 |
| Start Date: | January 6, 2017 |
| End Date: | September 30, 2019 |
| Contact: | Marise Cornelius |
| Email: | mcornelius@partners.org |
| Phone: | 617-732-9463 |
Chronic low back pain (CLBP) afflicts up to 50 million U.S. adults and is a primary cause of
disability and reduced quality of life. The prescription of opioids for chronic low back pain
(CLBP) has increased substantially within the past decade in the U.S. As noted by the CDC in
their recent Guideline (released in March 2016): "Opioids are commonly prescribed for pain.
An estimated 20% of patients presenting to physician offices with noncancer pain symptoms or
pain-related diagnoses (including acute and chronic pain) receive an opioid prescription.
Interestingly, patients scoring very high on measures of psychological distress tend to be
systematically excluded from RCTs, even though this subgroup of patients is highly prevalent
within the chronic pain population.
This study will provide key information on individual differences in the outcomes of opioid
treatment, and its findings should facilitate more effective tailoring of analgesic regimens
to individual patient characteristic.
disability and reduced quality of life. The prescription of opioids for chronic low back pain
(CLBP) has increased substantially within the past decade in the U.S. As noted by the CDC in
their recent Guideline (released in March 2016): "Opioids are commonly prescribed for pain.
An estimated 20% of patients presenting to physician offices with noncancer pain symptoms or
pain-related diagnoses (including acute and chronic pain) receive an opioid prescription.
Interestingly, patients scoring very high on measures of psychological distress tend to be
systematically excluded from RCTs, even though this subgroup of patients is highly prevalent
within the chronic pain population.
This study will provide key information on individual differences in the outcomes of opioid
treatment, and its findings should facilitate more effective tailoring of analgesic regimens
to individual patient characteristic.
Changes in pain sensitivity will be examined (i.e., OIH) among subgroups of CLBP patients
prescribed oral opioid therapy.
Investigators will conduct a moderate-term, double-blind, randomized controlled trial, and
use quantitative sensory testing (QST) to evaluate whether changes in pain sensitivity and
pain modulation occur as a result of long-term opioid use. Investigators hypothesize that
increases in pain sensitivity (i.e., OIH) and maladaptive changes in endogenous pain
modulation (i.e., enhanced temporal summation of pain) will occur as a result of long-term
opioid use, but that these changes will be observed predominantly among patients with high
levels of negative affect and pain-related catastrophizing.
prescribed oral opioid therapy.
Investigators will conduct a moderate-term, double-blind, randomized controlled trial, and
use quantitative sensory testing (QST) to evaluate whether changes in pain sensitivity and
pain modulation occur as a result of long-term opioid use. Investigators hypothesize that
increases in pain sensitivity (i.e., OIH) and maladaptive changes in endogenous pain
modulation (i.e., enhanced temporal summation of pain) will occur as a result of long-term
opioid use, but that these changes will be observed predominantly among patients with high
levels of negative affect and pain-related catastrophizing.
Inclusion Criteria:
1. age 25-65
2. CLBP lasting for more than 6 months as the primary complaint
3. typical pain ratings ≥ 4/10 on a visual analogue scale
4. candidate for oral opioid therapy as assessed at the BWH Pain Management Center
5. able to speak and understand English.
Exclusion Criteria:
1. evidence of delirium, dementia, psychosis, or other cognitive impairment preventing
completion of study procedures
2. current (i.e., active) substance use disorder (SUD)
3. past history of persistent opioid use (i.e., opioid use for more than 6 months) given
that this could affect the biological systems of interest in the present study
4. history of myocardial infarction or other serious cardiovascular condition
5. current peripheral neuropathy
6. current pregnancy, or intention to become pregnant during the study
7. current intrathecal pump.
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