Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Changes in Pain Sensitivity (Quantitative Sensory Testing)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CLBP lasting for more than 6 months as the primary complaint
- •typical pain ratings ≥ 4/10 on a visual analogue scale
- •candidate for oral opioid therapy as assessed at the BWH Pain Management Center
- •able to speak and understand English.
Exclusion Criteria
- •evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures
- •current (i.e., active) substance use disorder (SUD)
- •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
- •history of myocardial infarction or other serious cardiovascular condition
- •current peripheral neuropathy
- •current pregnancy, or intention to become pregnant during the study
- •current intrathecal pump.
Arms & Interventions
Oral Opioid Medication
The primary study medication will be oxycodone, with morphine sulfate immediate release (MSIR) as a backup in case of side effects
Intervention: Oxycodone or morphine sulfate immediate release (MSIR) (Drug)
Placebo Treatment
Placebo medications will be encapsulated in an opaque blinding capsule to ensure adequate blinding of study medications
Intervention: Placebo Treatment (Drug)
Outcomes
Primary Outcomes
Changes in Pain Sensitivity (Quantitative Sensory Testing)
Time Frame: 6 months
Pain Sensitivity will be assessed by Quantitative Sensory testing
Secondary Outcomes
No secondary outcomes reported
Investigators
Robert Edwards
Associate Professor of Anesthesia
Brigham and Women's Hospital