Back Injuries, Disc Herniation, Pain, Back, Spinal Stenosis, Spondylolisthesis, Spondylosis
Conditions
Keywords
Chronic pain, Surgery, opioid, acceptance and commitment therapy, Prevention
Brief summary
The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.
Interventions
BEHAVIORALACT intervention
One day in person workshop + telephone booster
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* scheduled to undergo fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy * age 22 and older * able to communicate fluently in English
Exclusion criteria
* inability to complete study procedures due to delirium, dementia, psychosis, or other cognitive impairment * have a history of severe neurologic movement disorder * are pregnant or intent to become pregnant during study * have undergone previous spinal surgery * have spinal deformity, pseudarthrosis, trauma, infection, or tumor as primary indication for surgery * have undergone Acceptance and Commitment Therapy in last 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Helpfulness | Immediately following the ACT workshop | Treatment Helpfulness Questionnaire (THQ); Item assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference | 1 month post-op | Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Items are rated from 1-5 and then summed with higher scores indicative of greater pain interference |
| Treatment Helpfulness | 1 month post-op | Treatment Helpfulness Questionnaire (THQ); Item assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful). |
| Opioid dose | 1 month post-op | We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review |
| Pain Intensity | 1 month post-op | Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity |
| Treatment Credibility | Immediately following ACT workshop | Credibility and Expectancy Questionnaire (CEQ); 3 items are rated to indicate the logic, success, and confidence in the treatment. Scores are summed with a range from 3-27 where higher scores indicating greater treatment credibility |
| Treatment Expectancy | Immediately following ACT workshop | Credibility and Expectancy Questionnaire (CEQ); 3 items are used to assess the likelihood of the success of the therapy to reduce pain and improve function. Scores are summed with a range from 0-29 where higher scores indicate greater expectancy for beneficial treatment outcomes |
Countries
United States
Outcome results
None listed