Back to resultsPREventing Pain After Surgery (PREPS)
Primary Purpose
Pain, Back, Spinal Stenosis, Disc Herniation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACT intervention
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Back focused on measuring Chronic pain, Surgery, opioid, acceptance and commitment therapy, Prevention
Eligibility Criteria
Inclusion Criteria:
- scheduled to undergo lumbar fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy
- 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
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ACT intervention
Treatment As Usual
Arm Description
Participants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery
Participants assigned to this arm will receive treatment as usual.
Outcomes
Primary Outcome Measures
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
Treatment Acceptability
Credibility and Expectancy Questionnaire (CEQ); Items are rated from 1-9 and then summed with higher scores indicative of greater acceptability
Secondary Outcome Measures
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
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
Opioid dose
We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review
Opioid dose
We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review
Opioid dose
We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review
Pain Intensity
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity
Pain Intensity
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity
Pain Intensity
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity
Full Information
NCT ID
NCT05306665
First Posted
February 23, 2022
Last Updated
August 9, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05306665
Brief Title
PREventing Pain After Surgery
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Back, Spinal Stenosis, Disc Herniation, Spondylosis, Spondylolisthesis, Back Injuries
Keywords
Chronic pain, Surgery, opioid, acceptance and commitment therapy, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
145 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACT intervention
Arm Type
Experimental
Arm Description
Participants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Participants assigned to this arm will receive treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
ACT intervention
Intervention Description
One day in person workshop + telephone booster
Primary Outcome Measure Information:
Title
Pain Interference
Description
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
Time Frame
3 months post-op
Title
Treatment Acceptability
Description
Credibility and Expectancy Questionnaire (CEQ); Items are rated from 1-9 and then summed with higher scores indicative of greater acceptability
Time Frame
1 month post-op
Secondary Outcome Measure Information:
Title
Pain Interference
Description
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
Time Frame
1 month post-op
Title
Pain Interference
Description
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
Time Frame
6 month post-op
Title
Opioid dose
Description
We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review
Time Frame
1 month post-op
Title
Opioid dose
Description
We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review
Time Frame
3 months post-op
Title
Opioid dose
Description
We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review
Time Frame
6 months post-op
Title
Pain Intensity
Description
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity
Time Frame
1 month post-op
Title
Pain Intensity
Description
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity
Time Frame
3 months post-op
Title
Pain Intensity
Description
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity
Time Frame
6 months post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha M Meints, PhD
Phone
6177329014
Email
smeints@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marise Cornelius, MBA
Email
mcornelius@bwh.harvard.edu
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
01467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha M Meints
Phone
617-732-9014
Email
smeints@bwh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The final dataset will be stripped of identifiers prior to release for sharing at the time of publication or shortly thereafter. The data will then be made available to approved outside collaborators under a data-sharing agreement that provides for (1) commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed. Further, the data will be shared via publication and/or public presentations.
IPD Sharing Time Frame
The time of publication or shortly afterward.
Learn more about this trial
PREventing Pain After Surgery
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