Low Back Pain
Conditions
Brief summary
This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group.
Interventions
BEHAVIORALMindfulness-Oriented Recovery Enhancement: (MORE) group
Mindfulness-Oriented Recovery Enhancement (MORE) is a novel social work intervention and mental training program that unites complementary aspects of mindfulness training.
BEHAVIORALPsychoeducation
Education on the neurobiology of pain, healthy eating, diet, sleep and stress
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Behavioral
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age\>18yo * Chronic Low Back Pain as seen on medical history as well as score of \>3 on pain visual analog scale (VAS) at the start of experimental sessions. * receiving prescription opioids for three or more months and planning to start tapering their opioids with their provider. * willing to be randomized to one of the two behavioral treatment. Patients referred or self-referred to the study from an outside clinic will also be able to participate (we will be in contact with their prescribing provider) * able and willing to perform/tolerate pain procedures (e.g., QST) * able to communicate fluently in English * able to use a smartphone or laptop for the virtual therapy program
Exclusion criteria
* Current illicit substance use (e.g marijuana use will be exempted) at screening or during trial as verified by urine toxicology screen and/or self-report for all participants; * Medical condition known to influence QST or participation in the MORE intervention; serious psychiatric condition; * regular meditation practice * cognitive impairment * pregnancy * lack of English fluency * severe OUD * inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference | Baseline, 8 weeks, 3 month and 6 month follow up | assessed by the Brief pain interventory |
| Opioid Dose | Baseline, 8 weeks, 3 month and 6 month follow up | assessed through their medical record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Baseline, 8 weeks, 3 month and 6 month follow up | assessed through the Brief Pain Inventory |
| Opioid Misuse | Baseline, 8 weeks, 3 month and 6 month follow up | assessed by the Current Opioid Misuse Measure (COMM) |
| Opioid Withdrawal | Baseline, 8 weeks, 3 month and 6 month follow up | assessed by the Opioid Withdrawal Scale (SOWS) |
| Opioid Craving | Baseline,8 weeks, 3 month and 6 month follow up | assessed by the single item Opioid Craving |
Countries
United States
Outcome results
None listed