Spinal Stenosis Clinical Trial
— PREPSOfficial title:
PREventing Pain After Surgery: A Feasibility and Acceptability Study of Acceptance and Commitment Therapy for the Prevention of Chronic Post-surgical Pain (PREPS)
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Chestnut Hill | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
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 |
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