Feasibility and Acceptability of Group Pain Reprocessing Therapy for Veterans With Chronic Neck/Back Pain

Chronic Pain Clinical Trial

— ESPRIT  

Official title:

Feasibility and Acceptability of Group Pain Reprocessing Therapy for Veterans With Chronic Neck/Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06406699
• Other study ID #: 23-1387
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2024
• Est. completion date: February 8, 2025

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Yoni Ashar, PhD
• Phone: 2405019030
• Email: yoni.ashar[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are conducting a trial that evaluates the feasibility of telehealth group pain reprocessing therapy (PRT), with no comparison group, for the treatment of chronic back pain in a population of veterans. PRT is a psychotherapy for chronic pain that aims to help patients reconceptualize their pain as a non-dangerous signal. It has been shown to be effective in a previous RCT (n=151).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 8, 2025
• Est. primary completion date: October 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 6 months of back pain with last week average back pain at least 4/10
• Able to attend at least 7/8 telehealth group sessions
• Access to safe living space, quite room, reliable internet, and electronic device that can be used to attend telehealth therapy sessions.

Exclusion Criteria:

• Leg pain that is worse than back pain
• Suicide attempt, SI, HI, or inpatient psychiatric hospitalization in the past 5 years
• Not receiving/has not received disability or workers compensation related to back pain in the past 2 years.
• Is not currently involved in litigation regarding chronic back pain.
• Current misuse or overuse of alcohol or drugs
• Major surgery or other major medical events in the next 6 months
• Known vertebral/spinal fracture or tumor.
• Back surgery within last 2 years
• Difficulty controlling bowel movements
• Current or recent diagnosis of cancer
• Current or recent diagnosis of severe cardiovascular disease
• Unexplained or unintended greater than 20 pound weight loss in the past year
• Diagnosis of rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, polymyositis, or other specific inflammatory disorders

Related Conditions & MeSH terms

• Back Pain
• Chronic Back Pain
• Chronic Pain
• Neck Pain

Intervention

Behavioral:
• Pain Reprocessing Therapy (PRT)
PRT is a psychological intervention for chronic pain patients with a primary nociplastic component. PRT aims to help patients reconceptualize their pain as a non-dangerous signal that is not indicative of tissue pathology or structural abnormality. Through decreasing the threat level of their chronic pain, the pain itself can also resolve.

Locations

Country	Name	City	State
United States	University of Colorado - Anschutz Medical Campus VA	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	VA Eastern Colorado Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PEG-3 Average Pain in last week	0-10 scale that asks participant to rate their average pain (0=No pain, 10=Pain as bad as possible) in the last week	Baseline, Post-treatment, and 4-months post-treatment