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Completed

NCT Number: NCT03985436

A Single Session Pain Psychology Class for Spine Surgery Patients

This project tests the feasibility a single session pain psychology class (TREK for Surgical Success) for patients undergoing spine surgery and compares outcomes in those who engage in the class to a historical group of similar patients undergoing usual care perioperatively. As of January 2020, the class option has been updated to include an online video module platform, to be used for patients unable to attend in person.

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Key information

Conditions

Lumbar; Injury Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

The proposed study intends to utilize a psychobehavioral protocol from Darnall and colleagues to deliver a single session behavioral medicine for pain intervention for the spine surgery patient entitled "TREK (Transform, Restore, Empower, Knowledge) for Surgical Success" (TREK for SS). The intervention is based off of the above noted evidence based 2 hour pain psychology class that has been used in the chronic pain population and is also currently being tested in other surgical populations. Use of this established and evidenced based treatment for the proposed project enhances the treatment fidelity. The proposed project addresses questions in the literature such as the benefits of this class in an in-person or online format and its adaptability and effectiveness in the spine surgery population.

The primary objective of the proposed project is to determine the feasibility of a single session digital behavioral medicine for pain intervention (TREK for SS) offered the perioperative period of lumbar spine surgery as measured by patient satisfaction and intervention acceptability ratings and retention rates. In this study the perioperative period is defined as a 8 week window straddling the surgery date. A secondary objective of the study is to gather preliminary data to support the efficacy of TREK for SS as measured by relevant post surgical outcomes compared to a group of historical controls who received usual care. Should this pilot study demonstrate effectiveness in lumbar spine surgery patients, there is the potential to study larger groups of patients and to integrate the class into the standard of care as a cost-effective intervention for the spine surgery population. Additionally, findings from this pilot study could substantiate the need for training in the class protocol across disciplines so that barriers to receiving pain psychology intervention can be minimized.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults 18 and older
  • Undergoing lumbar laminectomy with or without fusion

Exclusion criteria

  • None

Treatment and study plan

Trek for Surgical Success

Behavioral

Cognitive behavioral therapy for pain

Primary outcomes

  1. Patient Satisfaction and Acceptability (change/durability of intervention acceptability)

    Time frame: immediately after the intervention and 12 weeks post surgery

    4 item satisfaction survey; Likert scale (1=higher acceptability of intervention for each of the 5 items; 5=least satisfaction/acceptability of the intervention) assessing acceptability of intervention; lower total score reflects higher satisfaction and acceptability

  2. Engagement Rates of CBT-P intervention

    Time frame: within 2 weeks before or 2 weeks after surgery

    Class attendance

  3. Change in Modified Oswestry Disability Index (MDQ) pre to post treatment

    Time frame: before surgery and 12 weeks post surgery

    Back pain-related disability, The ODI is made up of 10 questions. Each question is scored from 0-5 (minimum to maximum).The point total from each section is summed and the then divided by the total number of questions answered and multiplied by 100 to create a percentage disability. The scores range from 0-100% with lower scores meaning less disability.

  4. Change in Pain Castastrophizing pre and post treatment

    Time frame: before surgery and 12 weeks post surgery

    13 item scale measuring pain catastrophizing; 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. The PCS total score is computed by summing responses to all 13 items.

    PCS total scores range from 0 - 52 with higher scores indicating higher catastrophizing

  5. Change in Depression

    Time frame: before surgery and 12 weeks post surgery

    Patient Health Questionnaire (PHQ-): 9-item depression questionnaire. Nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score. Scores of 0-4 suggest no depression; Scores of 5-9 suggest mild depression; scores of 10-14 suggest moderate depression; scores of 15-19 suggest moderate-severe depression; scores of 20-27 suggest severe depression

  6. Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health Scale

    Time frame: before surgery and 12 weeks post surgery

    The PROMIS Global-10 short form consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. Participant's measures are reported as a transformed scale (or T-score). A higher PROMIS T-score represents more of the concept being measured

  7. Change in Opioid Use

    Time frame: immediately after the intervention, 12 weeks post surgery

    Patient self reported: 1)opioid type; 2) surgical opioids yes/no; 3) total mg in past 24 hours; more than prescribed yes/no

  8. Change in PROMIS Pain Interference

    Time frame: before surgery and 12 weeks post surgery

    This scale measures the construct of pain interference. Pain interference refers to the degree to which pain limits or interferes with an individual's physical, mental, and social activities. PROMIS Pain Interference scores are reported as a transformed scale (or T-score). A higher PROMIS T-score represents more of the concept being measured

Sponsors and collaborators

Lead sponsor

Sara Davin, PsyD, MPH

Other

Registry information

Official study title

A Pilot and Feasibility Study of a Single Session Pain Psychology Class for the Spine Surgery Patient: TREK (Transform, Restore, Empower, Knowledge) for Surgical Success

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 13, 2019
Registry last updated
Nov 17, 2020

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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