A Single Session Pain Psychology Class for Spine Surgery Patients

Lumbar; Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985436
• Other study ID #: 19-124
• Status: Completed
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: November 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults 18 and older

• Undergoing lumbar laminectomy with or without fusion

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Lumbar; Injury

Intervention

Behavioral:
• Trek for Surgical Success
Cognitive behavioral therapy for pain

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Sara Davin, PsyD, MPH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction and Acceptability (change/durability of intervention acceptability)	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
Primary	Engagement Rates of CBT-P intervention	Class attendance	within 2 weeks before or 2 weeks after surgery
Primary	Change in Modified Oswestry Disability Index (MDQ) pre to post treatment	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
Primary	Change in Pain Castastrophizing pre and post treatment	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
Primary	Change in Depression	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
Primary	Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health Scale	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
Primary	Change in Opioid Use	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
Primary	Change in PROMIS Pain Interference	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