Chronic Back PainESPRITNCT06406699
Feasibility and Acceptability of Group Pain Reprocessing Therapy for Veterans With Chronic Neck/Back Pain
A study testing Pain Reprocessing Therapy (PRT) in people with Chronic Back Pain and Chronic Pain, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Back Pain, Chronic Pain, Neck Pain
- What is being tested?
- Pain Reprocessing Therapy (PRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to 8 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado - Anschutz Medical Campus VA
Aurora, Colorado, 80045
About this study
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).
- Conditions
- Chronic Back Pain, Chronic Pain, Neck Pain, Back Pain
- Being tested
- Pain Reprocessing Therapy (PRT)
- Medical subject headings
- Chronic Pain, Neck Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Reprocessing Therapy (PRT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pain Reprocessing Therapy (PRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Post-treatment, and 2-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start17 Apr 2024
- Primary completion25 Jan 2025
- Study completion8 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Back PainStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- VA Eastern Colorado Health Care System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406699
- Sponsor's protocol ID
- 23-1387
- Acronym
- ESPRIT
- Status last verified
- Jul 2025
- First submitted
- 6 May 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Group Pain Reprocessing Therapy for Veterans With Chronic Neck/Back Pain
- ClinicalTrials.gov ID
- NCT06406699
- Acronym / sponsor ID
- ESPRIT / 23-1387
- Conditions
- Chronic Back Pain, Chronic Pain, Neck Pain, Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- VA Eastern Colorado Health Care System
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 8 Feb 2025 (actual)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain Reprocessing Therapy | Experimental | Behavioral: Pain Reprocessing Therapy (PRT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Pain Reprocessing Therapy |
Primary outcome
PEG-3 Average Pain in last week
Time frame: Baseline, Post-treatment, and 2-months post-treatment
0-10 scale that asks participant to rate their average pain (0=No pain, 10=Pain as bad as possible) in the last week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Reprocessing Therapy (PRT) in people with Chronic Back Pain and Chronic Pain, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PEG-3 Average Pain in last week (time frame: Baseline, Post-treatment, and 2-months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.