PREventing Pain After Surgery

Study Overview
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Brief Summary
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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.

Official Title
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PREventing Pain After Surgery: A Feasibility and Acceptability Study of Acceptance and Commitment Therapy for the Prevention of Chronic Post-surgical Pain (PREPS)

Conditions
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Pain, Back, Spinal Stenosis, Disc Herniation, Spondylosis, Spondylolisthesis, Back Injuries

Intervention / Treatment
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* Behavioral: ACT intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT intervention<br>Participants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery | Behavioral: ACT intervention<br>* One day in person workshop + telephone booster<br>|
| No Intervention: Treatment As Usual<br>Participants assigned to this arm will receive treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Interference | 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 | 3 months post-op | 
| Treatment Acceptability | Credibility and Expectancy Questionnaire (CEQ); Items are rated from 1-9 and then summed with higher scores indicative of greater acceptability | 1 month post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Interference | 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 | 1 month post-op | 
| Pain Interference | 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 | 6 month post-op | 
| Opioid dose | We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review | 1 month post-op | 
| Opioid dose | We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review | 3 months post-op | 
| Opioid dose | We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review | 6 months post-op | 
| Pain Intensity | Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity | 1 month post-op | 
| Pain Intensity | Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity | 3 months post-op | 
| Pain Intensity | Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity | 6 months post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Surgery, opioid, acceptance and commitment therapy, Prevention