Clinical trial NCT03985436: A Single Session Pain Psychology Class for Spine Surgery Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar; Injury
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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. 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Patient Satisfaction and Acceptability (change/durability of intervention acceptability)
timeFrame: immediately after the intervention and 12 weeks post surgery
measure: Engagement Rates of CBT-P intervention
timeFrame: within 2 weeks before or 2 weeks after surgery
measure: Change in Modified Oswestry Disability Index (MDQ) pre to post treatment
timeFrame: before surgery and 12 weeks post surgery
measure: Change in Pain Castastrophizing pre and post treatment
timeFrame: before surgery and 12 weeks post surgery
measure: Change in Depression
timeFrame: before surgery and 12 weeks post surgery
measure: Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health Scale
timeFrame: before surgery and 12 weeks post surgery
measure: Change in Opioid Use
timeFrame: immediately after the intervention, 12 weeks post surgery
measure: Change in PROMIS Pain Interference
timeFrame: before surgery and 12 weeks post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Sara Davin, PsyD, MPH
role: PRINCIPAL_INVESTIGATOR
References: