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A Single Session Pain Psychology Class for Spine Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03985436
Recruitment Status : Enrolling by invitation
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Information provided by (Responsible Party):
Sara Davin, PsyD, MPH, The Cleveland Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lumbar; Injury Behavioral: Trek for Surgical Success Not Applicable

Detailed Description:

The proposed study intends to utilize a psychobehavioral protocol from Darnall and colleagues to deliver a single session class for the spine surgery patient entitled "TREK (Transform, Restore, Empower, Knowledge) for Surgical Success" (TREK for SS). The class 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 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 CBT-P class (¡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 4 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : January 31, 2020

Arm Intervention/treatment
Experimental: Trek for Surgical Success
Cognitive behavioral therapy for pain
Behavioral: Trek for Surgical Success
Cognitive behavioral therapy for pain

Primary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03985436

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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Sara Davin, PsyD, MPH
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Principal Investigator: Sara Davin, PsyD, MPH The Cleveland Clinic

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Responsible Party: Sara Davin, PsyD, MPH, Principal Investigator, The Cleveland Clinic Identifier: NCT03985436     History of Changes
Other Study ID Numbers: 19-124
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No