PREventing Pain After Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
scheduled to undergo fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy
age 22 and older
able to communicate fluently in English
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ACT intervention
BehavioralOne day in person workshop + telephone booster
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: ACT interventionExperimental treatment 1 intervention
Group B: Treatment As UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Immediately following the ACT workshopSecondary outcomes
1
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
Time frame
1 month post-op2
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
Time frame
3 months post-op3
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
Time frame
6 month post-op4
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).
Time frame
1 month post-opSponsors and contacts
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Source ClinicalTrials.gov