- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03985436
A Single Session Pain Psychology Class for Spine Surgery Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults 18 and older
- Undergoing lumbar laminectomy with or without fusion
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trek for Surgical Success
Cognitive behavioral therapy for pain
|
Cognitive behavioral therapy for pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
immediately after the intervention and 12 weeks post surgery
|
Engagement Rates of CBT-P intervention
Time Frame: within 2 weeks before or 2 weeks after surgery
|
Class attendance
|
within 2 weeks before or 2 weeks after surgery
|
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.
|
before surgery and 12 weeks post surgery
|
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 |
before surgery and 12 weeks post surgery
|
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
|
before surgery and 12 weeks post surgery
|
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
|
before surgery and 12 weeks post surgery
|
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
|
immediately after the intervention, 12 weeks post surgery
|
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
|
before surgery and 12 weeks post surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara Davin, PsyD, MPH, The Cleveland Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19-124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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