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Recruiting NCT05306665

PREventing Pain After Surgery

No phase Interventional Pain, Back Spinal Stenosis Disc Herniation Spondylosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ACT intervention.
Who it may be relevant to
Registry conditions: Pain, Back, Spinal Stenosis, Disc Herniation, Spondylosis. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

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

Primary outcome measures

  • Treatment Helpfulness [Time frame: Immediately following the ACT workshop]
Secondary outcome measures (12)
  • Pain Interference [Time frame: 1 month post-op]
  • Pain Interference [Time frame: 3 months post-op]
  • Pain Interference [Time frame: 6 month post-op]
  • Treatment Helpfulness [Time frame: 1 month post-op]
  • Opioid dose [Time frame: 1 month post-op]
  • Opioid dose [Time frame: 3 months post-op]
  • Opioid dose [Time frame: 6 months post-op]
  • Pain Intensity [Time frame: 1 month post-op]
  • Pain Intensity [Time frame: 3 months post-op]
  • Pain Intensity [Time frame: 6 months post-op]
  • Treatment Credibility [Time frame: Immediately following ACT workshop]
  • Treatment Expectancy [Time frame: Immediately following ACT workshop]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Chestnut Hill

Identifiers

NCT: NCT05306665 · 2022P002302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗