Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery

Pain, Chronic Clinical Trial

Official title:

Efficacy of a Single-session Treatment for Reducing Chronic Pain Prior to Gender-affirming Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06443164
• Other study ID #: STUDY00026520
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2024
• Source: Oregon Health and Science University
• Contact: Jenna W. Stapleton, PhD
• Phone: 503-418-1980
• Email: stapletj[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to examine a single-session, 2-hour group intervention provided to a population of transgender or gender-diverse patients with chronic pain prior to gender-affirming surgery, to determine if participants who receive the intervention have less pain-related distress compared to participants randomly assigned to the control group.

Description:

The primary objective of this study is to examine a single-session, 2-hour group intervention provided to a population of transgender and gender-diverse patients with chronic pain prior to gender-affirming surgery, to determine if participants who receive the intervention have less pain-related distress compared to participants randomly assigned to the control group. This study will help extend the research literature on chronic pain experienced by transgender patients, and specifically will examine if a brief, group intervention is effective for reducing pain catastrophizing and pain distress prior to surgery.

Safety and effectiveness of the Empowered Relief intervention used in this study has been demonstrated in multiple clinical trials, but has not been studied yet with this particular population. The Empowered relief intervention was created by Beth Darnall © Stanford University.

The hypothesis of this research study is that transgender patients with chronic pain who receive the group intervention, prior to having a gender-affirming surgery, will have lower scores on the pain catastrophizing scale after completing the intervention compared to participants in the control group:

Hypothesis: µ1 <(<=) µ2. The primary endpoint of this study is to test if the mean change in the score on the Pain Catastrophizing Scale is different between the treatment and the control group. The secondary endpoint, is to examine if pain severity scores decreased. An exploratory endpoint, after data collection and analysis is complete, is to run a focus group with participants who received the intervention to learn more about their experience to inform future treatment and research. Safety endpoints are that participants will receive informed consent, which will include learning they may discontinue participation in the study at any time, as well as procedures for maintaining confidentiality of identifying information. Each person screened will already be referred to the Transgender Health Program by a primary care provider and/or mental health provider. If screening indicates that a person has severe depression or regular thoughts involving suicidal content, then that person will not be included in the study but instead will be offered resources and highly recommended to contact their referring provider for additional support.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. affiliated with the OHSU Transgender Health Program and have completed their initial consultation for gender-affirming surgery,

2. who have chronic pain (defined as > 3 months of pain),

3. who rate their average level of pain intensity as at least a 4 or higher (on 0-10 pain scale)

4. who have fluency in English. Empowered Relief may only be delivered by a certified instructor, and for this research study the instructor is only able to offer the curriculum in English.

Exclusion Criteria:

1. have had a pain-focused behavioral therapy in the past year, or

2. have severe depression and/or moderate or higher risk of suicidality based on the person's score on the PHQ-9 greater than 20.

Related Conditions & MeSH terms

• Chronic Pain
• Gender Identity
• Pain Catastrophizing
• Pain, Chronic
• Transgenderism

Intervention

Behavioral:
• Empowered Relief
Pain Management Course that has been used to treat pain in patients with different pain conditions.

Other:
• Standard of Care
Gender Affirming surgery without any attention to pain conditions prior to surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Catastrophizing	This measure is a 13-item self-assessment instrument of pain-related negative thoughts, and measures constructs of rumination, magnification and helplessness. It is the primary outcome measure of this research study. Each item is measured on a 5-point Likert scale, with endpoints 0 (not at all) to 4 (all the time) and possible scores ranging from 0-52. In a clinical setting, such as a pain clinic providing treatments for chronic pain, a score on this measure of "10" or higher indicates a person could benefit from treatment; however, the published cut-off scores are higher and as follows: a Total Score of 20 is considered in the average range (50th percentile), and a Total Score of >= 30 is above average (75th percentile). This measure is shown to have excellent internal consistency (coefficient alphas: total PCS = .87, rumination = .87, magnification = .66, and helplessness = .78.	Participants will be assessed as part of a cohort for up to 7 months. There will be a total of three cohorts.