PREventing Pain After Surgery

Not Applicable

Recruiting

• Conditions: Pain, Back; Spinal Stenosis; Spondylolisthesis; Disc Herniation; Back Injuries; Spondylosis

• Registration Number: NCT05306665
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-04-01
• Study Start: 2023-01-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-28
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pain Interference	6 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	6 months post-op	We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review
Pain Intensity	6 months 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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Chestnut Hill, Massachusetts, United States