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Pain Reprocessing Therapy for Chronic Back Pain
N/A
Recruiting
Led By Jonathan K. Ashar, Ph.D.
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Back pain that is worse than leg pain
Last-week average back pain of at least 4 of 10 at the two pretreatment timepoints (online pre-screening and informed consent session)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up primary time point is the day after post-treatment, 1.5 months on average
Awards & highlights
Study Summary
This trial will compare 3 treatments to see which works better for reducing chronic pain in adults. #medicaltrial #chronicpain
Who is the study for?
This trial is for adults with chronic back pain lasting at least 6 months, where the back pain is more frequent and severe than leg pain. Participants must have a consistent level of pain and be able to attend telehealth appointments. Those with recent major medical events, surgeries, or psychiatric issues, or who are involved in litigation related to their pain cannot join.Check my eligibility
What is being tested?
The study compares Pain Reprocessing Therapy (PRT), Cognitive Behavioral Therapy (CBT) for Chronic Pain, and usual care to determine which method best reduces chronic back pain and improves associated problems. It aims to find out if PRT can effectively lower chronic pain compared to CBT or ongoing treatments.See study design
What are the potential side effects?
Since this trial involves therapy sessions rather than medication, side effects may include emotional discomfort due to discussing painful experiences but typically do not involve physical side effects like those from drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My back pain is more severe than my leg pain.
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My back pain has been at least 4 out of 10 in the last week.
Select...
I have had back pain for most days in the past 6 months.
Select...
My back pain is more severe than my leg pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ primary time point is the day after post-treatment, 1.5 months on average
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~primary time point is the day after post-treatment, 1.5 months on average
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain intensity
Session Attendance
Secondary outcome measures
Anger
Anxiety
Client satisfaction
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Pain reprocessing therapy (PRT)Experimental Treatment1 Intervention
PRT has 5 components: 1) education about the origin of pain in the brain, its reversibility, and the pain-fear cycle; 2) reinforcing education using personal biography; 3) "somatic tracking" of pain through mindfulness and reappraisal of pain sensations as non-dangerous; 4) lowering the level of personal threat that may trigger pain sensation; and 5) inducing positive affect in periods of pain. Patients will attend 1 assessment and education telehealth session with a physician followed by 8, 50-minute, therapist-led sessions. Pacing will be flexible, ranging from 5-12 weeks, to increase accessibility. Treatment will be provided by experienced PRT clinicians. All PRT sessions will be remotely-delivered.
Group II: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)Active Control1 Intervention
CBT-CP, considered the leading psychological treatment for chronic pain, is a structured, time-limited intervention that aims to teach patients how to better manage chronic pain and improve their quality of life. Participants will receive 9, 50-minute sessions of CBT-CP over 5 - 12 weeks. The VA CBT-CP protocol contains an initial orientation involving education and familiarization with the CBT-CP approach to chronic pain. The protocol then includes sessions that focus on topics such as exercise, relaxation, pleasant activities, cognitive coping, and sleep. All CBT-CP sessions will be remotely-delivered.
Group III: Usual CareActive Control1 Intervention
Participants will be asked to continue whatever they are already doing to care for their back pain. Length of the usual care condition will be 5 weeks, the expected mean completion time of the PRT and CBT arms, and may be adjusted at mid-enrollment to match treatment arm length more closely.
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,508 Total Patients Enrolled
4 Trials studying Back Pain
615 Patients Enrolled for Back Pain
Jonathan K. Ashar, Ph.D.Principal InvestigatorUniversity of Colorado - Anschutz Medical Campus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You were hospitalized for mental health reasons in the past 5 years.I have lost 20lbs or more recently without trying.I do not have any major surgeries or medical events planned in the next six months.My back pain has been at least 4 out of 10 in the last week.I have a serious illness like heart disease or a recent cancer diagnosis.My leg pain is worse than my back pain.You are not sure if you will have the right tools and a quiet place for online doctor appointments over the next two months.I have had back pain for most days in the past 6 months.I have trouble controlling my bladder.Unstable living situation or major life events that can interfere with the study.I have feeling or movement issues in my trunk or legs.I have not had back surgery in the last 2 years.I have had a recent spinal fracture or have known spinal tumors.I have been diagnosed with a specific inflammatory disorder like rheumatoid arthritis or Lupus.My back pain is more severe than my leg pain.I have not had thoughts of harming myself or attempted suicide in the last 5 years.My back pain is more severe than my leg pain.You are currently experiencing severe mental health issues like hallucinations or extreme mood swings.You are currently using drugs or have had problems with drug use in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
- Group 2: Pain reprocessing therapy (PRT)
- Group 3: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being incorporated into this experiment?
"Affirmative. According to the information provided by clinicaltrials.gov, this medical trial is presently recruiting patients, with its initial post dating back to April 10th 2023 and last edited on April 18th 2023. The study aims at enrolling 75 participants from one site only."
Answered by AI
Are there any vacancies available to take part in this research?
"Affirmative, the clinicaltrials.gov website states that this medical study is actively searching for volunteers. This trial was first published on April 10th 2023 and was recently modified on April 18th 2023; 75 participants need to be recruited from one facility."
Answered by AI
What are the desired benefits of participating in this clinical investigation?
"This clinical trial's primary outcome is the rate of Session Attendance, measured one day post-treatment and averaged over 1.5 months. Secondary outcomes entail assessing Depression via the 8-item PROMIS depression sub-scale, Positive Affect through a 10-question PANAS survey, and Anxiety with another 8 items on the PROMIS anxiety sub-scale, all rated from 1 to 5."
Answered by AI
Who else is applying?
What site did they apply to?
University of Colorado Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’ve had multiple spine fusions and STILL have lower back pain. I’ve also tried other drug therapies … robaxin, Oxycodone, celebrex …. With minimal improvement.
PatientReceived 1 prior treatment
Tried everything for back pain: surgery, meds, OTC, acupuncture, PT, Spinal programs, chiropractic, dry needling, CBD nothing has helped. I’m young with two young boys and the pain is controlling my life.
PatientReceived 1 prior treatment
I have lived with chronic pain in various areas of my body and been diagnosed with different conditions from fibromyalgia to chronic fatigue, I have read a lot about pain reprocessing therapy but have had a difficult time applying it to my situation given my age, and length of time I've had chronic pain, I feel a lot of the research has been mostly with younger people than myself.
PatientReceived 1 prior treatment
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