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NCT Number: NCT05306665

PREventing Pain After Surgery

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.

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Key information

Conditions

Pain, Back Back Injuries Back Pain Bone Diseases Chronic Pain Disc Herniation Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spinal Stenosis Spondylolisthesis Spondylolysis Spondylosis Wounds and Injuries

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 01467, United States

Location status: Recruiting

Location contact

Samantha M Meints

CONTACT

[email protected]

6177329014

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACT intervention

Behavioral

One day in person workshop + telephone booster

Primary outcomes

  1. Treatment Helpfulness

    Time frame: Immediately following the ACT workshop

    Treatment Helpfulness Questionnaire (THQ); Item assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful).

Secondary outcomes

  1. Pain Interference

    Time frame: 1 month post-op

    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

  2. Pain Interference

    Time frame: 3 months post-op

    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. Pain Interference

    Time frame: 6 month post-op

    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

  4. Treatment Helpfulness

    Time frame: 1 month post-op

    Treatment Helpfulness Questionnaire (THQ); Item assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful).

  5. Opioid dose

    Time frame: 1 month post-op

    We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review

  6. Opioid dose

    Time frame: 3 months post-op

    We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review

  7. Opioid dose

    Time frame: 6 months post-op

    We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review

  8. Pain Intensity

    Time frame: 1 month post-op

    Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity

  9. Pain Intensity

    Time frame: 3 months post-op

    Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity

  10. Pain Intensity

    Time frame: 6 months post-op

    Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity

  11. Treatment Credibility

    Time frame: Immediately following ACT workshop

    Credibility and Expectancy Questionnaire (CEQ); 3 items are rated to indicate the logic, success, and confidence in the treatment. Scores are summed with a range from 3-27 where higher scores indicating greater treatment credibility

  12. Treatment Expectancy

    Time frame: Immediately following ACT workshop

    Credibility and Expectancy Questionnaire (CEQ); 3 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 0-29 where higher scores indicate greater expectancy for beneficial treatment outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Marise Cornelius, MBA

CONTACT

[email protected]

Samantha M Meints, PhD

CONTACT

[email protected]

6177329014

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Acronym: PREPS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2022
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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