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Multimodal Treatments for Chronic Lower Back Pain (BACPAC Trial)

Phase 4
Recruiting
Led By Afton Hassett, PsyD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acupressure: Currently receiving acupressure or acupuncture through formal therapy
Normal visual acuity or correctable (with corrective lenses- glasses or contacts) to at least 20/40 for reading instructions in the MRI and visual sensitivity testing
Must not have
Osteoporosis requiring treatment other than vitamin D and calcium supplements
Diagnosis of any vertebral fracture in the last 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 (t2), week 15 (t3)
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial will help identify who benefits from different chronic pain treatments and how these treatments work.

Who is the study for?
This trial is for individuals with chronic lower back pain lasting at least six months, who are right-handed, can lie still for MRI scans, and don't have severe health issues like osteoporosis or uncontrolled addiction. Participants must not be pregnant, involved in other conflicting studies, expecting surgery within a year, or on high opioid doses.
What is being tested?
The study tests four treatments: mindfulness-based stress reduction (MBSR), physical therapy with exercise, self-administered acupressure, and the medication duloxetine. After an initial assessment period using PainGuide and MRIs among others tools participants may receive two different treatments sequentially if they still have significant pain.
What are the potential side effects?
Possible side effects include typical reactions to mindfulness practices such as discomfort during meditation; physical therapy might cause muscle soreness; acupressure could result in bruising or tenderness; duloxetine may lead to nausea, dry mouth, sleepiness or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently undergoing acupressure or acupuncture therapy.
Select...
My vision, with glasses or contacts, is good enough to read MRI instructions.
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I can stay still on my back for 2 hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am being treated for osteoporosis with more than just vitamins.
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I have had a spinal fracture in the past 6 months.
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I am currently undergoing acupressure or acupuncture therapy.
Select...
I have been diagnosed with nerve damage in my hands or feet.
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My liver tests are up to 1.5 times the normal limit.
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I am scheduled for, or had back surgery within the last year, or had multiple back surgeries.
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I cannot receive acupressure due to health reasons.
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My kidney function is very low or I have end-stage renal failure.
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I take more than 100mg of morphine or its equivalent daily.
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I do not have severe vision or hearing problems.
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I cannot do physical therapy or exercise due to health reasons.
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I have had cauda equina syndrome or spinal nerve root problems causing weakness.
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I have had a spine infection or tumor in the past.
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I have no health issues preventing me from participating in mindfulness-based stress reduction (MBSR).
Select...
I cannot participate in physical therapy or exercise due to health reasons.
Select...
I cannot take duloxetine due to health reasons.
Select...
I am currently undergoing physical therapy or exercise for low-back pain.
Select...
I cannot speak or write in English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6 (t2), week 15 (t3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 (t2), week 15 (t3) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a between week 6 to week 15
Secondary study objectives
Change in Patient Global Impression of Change (PGIC) from week 6 to week 15
Dental Pins

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

17Treatment groups
Experimental Treatment
Group I: PainGuideExperimental Treatment1 Intervention
Run-in treatment only with no additional treatments.
Group II: PT and exercise then MBSRExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of MBSR.
Group III: PT and exercise then DuloxetineExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of PT and exercise, and then approximately 8 weeks of Duloxetine
Group IV: PT and exercise then AcupressureExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of Acupressure
Group V: PT and exerciseExperimental Treatment3 Interventions
Run-in treatment then PT and exercise
Group VI: MBSR then PT and exerciseExperimental Treatment4 Interventions
Run-in treatment then 8 weeks of MBSR, and then 8 weeks of PT and exercise.
Group VII: MBSR then DuloxetineExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of MBSR, and then approximately 8 weeks of Duloxetine
Group VIII: MBSR then AcupressureExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of MBSR, and then 8 weeks Acupressure.
Group IX: MBSR (mindfulness-based stress reduction)Experimental Treatment3 Interventions
Run-in treatment then MBSR.
Group X: Duloxetine then PT and exerciseExperimental Treatment4 Interventions
Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of PT and exercise
Group XI: Duloxetine then MBSRExperimental Treatment4 Interventions
Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of MBSR.
Group XII: Duloxetine then AcupressureExperimental Treatment4 Interventions
Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks Acupressure.
Group XIII: DuloxetineExperimental Treatment3 Interventions
Run-in treatment then Duloxetine
Group XIV: Acupressure then PT and exerciseExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of PT and exercise.
Group XV: Acupressure then MBSRExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of MBSR
Group XVI: Acupressure then DuloxetineExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of Acupressure, and then approximately 8 weeks of Duloxetine
Group XVII: AcupressureExperimental Treatment3 Interventions
Run-in treatment then Acupressure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MBSR
2016
Completed Phase 3
~2200
Duloxetine
2011
Completed Phase 4
~4170

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,852 Previous Clinical Trials
6,432,241 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,089,012 Total Patients Enrolled
Afton Hassett, PsyDPrincipal Investigator - University of Michigan
University of Michigan
1 Previous Clinical Trials
2 Total Patients Enrolled

Media Library

Duloxetine Clinical Trial Eligibility Overview. Trial Name: NCT04870957 — Phase 4
Chronic Lower Back Pain Research Study Groups: MBSR then Duloxetine, PainGuide, PT and exercise then Acupressure, MBSR then Acupressure, PT and exercise then MBSR, Duloxetine then PT and exercise, Duloxetine then Acupressure, MBSR (mindfulness-based stress reduction), PT and exercise, Acupressure, Duloxetine, MBSR then PT and exercise, PT and exercise then Duloxetine, Acupressure then MBSR, Acupressure then PT and exercise, Acupressure then Duloxetine, Duloxetine then MBSR
Chronic Lower Back Pain Clinical Trial 2023: Duloxetine Highlights & Side Effects. Trial Name: NCT04870957 — Phase 4
Duloxetine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04870957 — Phase 4
~211 spots leftby Jun 2027
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