Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
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|ClinicalTrials.gov Identifier: NCT02824276|
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : January 28, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Drug: Oxycodone or morphine sulfate immediate release (MSIR) Drug: Placebo Treatment||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain|
|Actual Study Start Date :||January 6, 2017|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: Oral Opioid Medication
The primary study medication will be oxycodone, with morphine sulfate immediate release (MSIR) as a backup in case of side effects
Drug: Oxycodone or morphine sulfate immediate release (MSIR)
Oxycodone or morphine sulfate immediate release (MSIR)
Other Name: Oral Opioid Medication
Placebo Comparator: Placebo Treatment
Placebo medications will be encapsulated in an opaque blinding capsule to ensure adequate blinding of study medications
Drug: Placebo Treatment
Lactose (Appearance and Weight-matched placebo capsules)
- Changes in Pain Sensitivity (Quantitative Sensory Testing) [ Time Frame: 6 months ]Pain Sensitivity will be assessed by Quantitative Sensory testing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824276
|Contact: Marise Corneliusemail@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02467|
|Contact: Robert Edwards, PhD|
|Principal Investigator:||Robert Edwards, PhD||Brigham and Women's Hospital|