NCT06406699

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2025

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

May 6, 2024

Last Update Submit

July 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 2-months post-treatment

Study Arms (1)

Pain Reprocessing Therapy

EXPERIMENTAL

Participants will participate in once weekly telehealth group pain reprocessing therapy. Sessions will last approximately 1 hour in length. Group size will be approximately 10 individuals.

Behavioral: Pain Reprocessing Therapy (PRT)

Interventions

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.

Pain Reprocessing Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado - Anschutz Medical Campus VA

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Chronic PainNeck PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

April 17, 2024

Primary Completion

January 25, 2025

Study Completion

February 8, 2025

Last Updated

July 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations