PREventing Pain After Surgery

Spinal Stenosis Clinical Trial

— PREPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05306665
• Other study ID #: 2022P002302
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2023
• Est. completion date: August 1, 2026

Study information

• Verified date: April 2024
• Source: Brigham and Women's Hospital
• Contact: Samantha M Meints, PhD
• Phone: 6177329014
• Email: smeints[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Injuries
• Back Pain
• Disc Herniation
• Intervertebral Disc Displacement
• Pain, Back
• Spinal Stenosis
• Spondylolisthesis
• Spondylosis

Intervention

Behavioral:
• ACT intervention
One day in person workshop + telephone booster

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Treatment Helpfulness	Treatment Helpfulness Questionnaire (THQ); Item assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful).	Immediately following the ACT workshop
Secondary	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
Secondary	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
Secondary	Opioid dose	We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review	1 month post-op
Secondary	Opioid dose	We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review	3 months post-op
Secondary	Opioid dose	We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review	6 months post-op
Secondary	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
Secondary	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
Secondary	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
Secondary	Treatment Credibility	Credibility and Expectancy Questionnaire (CEQ); 3 items are rated 1 (not at all) to 9 (very) to indicate the logic, success, and confidence in the treatment. Scores are summed with higher scores indicating greater treatment credibility	Immediately following ACT workshop
Secondary	Treatment Expectancy	Credibility and Expectancy Questionnaire (CEQ); 4 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 2-28 where higher scores indicate greater expectancy for beneficial treatment outcomes	Immediately following ACT workshop
Secondary	Treatment Helpfulness	Treatment Helpfulness Questionnaire (THQ); Item assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful).	1 month post-op