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Combination Product

Spinal Manipulation + Self-Management for Back Pain (PACBACK Trial)

Phase 3
Waitlist Available
Led By Gert Bronfort, PhD, DC
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age
Acute or sub-acute low back pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, and 1, 2, 6, 12 months
Awards & highlights

PACBACK Trial Summary

This trial is looking at ways to reduce the burden of low back pain by testing scalable, first-line, non-pharmacologic strategies that address the biopsychosocial aspects of acute/sub-acute LBP and prevent transition to chronic back pain.

Who is the study for?
Adults at least 18 years old with a recent flare-up of low back pain, who are at medium or high risk for chronic pain. Participants must be able to read and write English fluently and have an average pain severity of 3 or more out of 10. Those with spinal surgery, pregnant or nursing women, people under other back pain treatments, or with serious health conditions cannot join.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Spinal Manipulation Therapy (SMT), Supported-Self Management (SSM), a combination of both SMT + SSM, against Standard Medical Care (SMC) in preventing acute low back pain from becoming chronic. The study lasts up to eight weeks with one year follow-up.See study design
What are the potential side effects?
While not specified here, common side effects from spinal manipulation can include temporary discomfort in treated areas. Self-management guidance should have minimal risks but may include frustration if improvements aren't seen.

PACBACK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am currently experiencing new or recent low back pain.
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My average lower back pain is 3 or more on a scale of 0 to 10.

PACBACK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, and 1, 2, 6, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, and 1, 2, 6, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average disability over one year post-randomization
Average pain intensity over one year post-randomization
Prevention of chronic low back pain (LBP) that is impactful at 10-12 months follow-up
Secondary outcome measures
Adverse Events
Chronic Interference with Daily Activities
Covid 19 Impact
+19 more
Other outcome measures
Catastrophizing
Coping
Kinesiophobia
+1 more

PACBACK Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Supported-Self management (SSM)Experimental Treatment1 Intervention
Supported-Self management
Group II: Spinal Manipulation Therapy (SMT)Experimental Treatment1 Intervention
Spinal Manipulation Therapy
Group III: SMT + SSMExperimental Treatment1 Intervention
Spinal Manipulation Therapy + Supported Self-Management
Group IV: Standard Medical Care (SMC)Active Control1 Intervention
Standard Medical Care

Find a Location

Who is running the clinical trial?

University of North Texas Health Science CenterOTHER
39 Previous Clinical Trials
19,172 Total Patients Enrolled
8 Trials studying Low Back Pain
11,557 Patients Enrolled for Low Back Pain
Oregon Health and Science UniversityOTHER
976 Previous Clinical Trials
7,385,269 Total Patients Enrolled
4 Trials studying Low Back Pain
256,104 Patients Enrolled for Low Back Pain
Duke UniversityOTHER
2,367 Previous Clinical Trials
3,423,847 Total Patients Enrolled
14 Trials studying Low Back Pain
6,321 Patients Enrolled for Low Back Pain

Media Library

SMT + SSM (Combination Product) Clinical Trial Eligibility Overview. Trial Name: NCT03581123 — Phase 3
Low Back Pain Research Study Groups: Supported-Self management (SSM), Spinal Manipulation Therapy (SMT), SMT + SSM, Standard Medical Care (SMC)
Low Back Pain Clinical Trial 2023: SMT + SSM Highlights & Side Effects. Trial Name: NCT03581123 — Phase 3
SMT + SSM (Combination Product) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03581123 — Phase 3
Low Back Pain Patient Testimony for trial: Trial Name: NCT03581123 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more patients needed for this research project?

"Correct, the online clinicaltrials.gov registry currently lists this trial as recruiting patients. This particular study was first made public on October 25th, 2018 and updated July 12th, 2020. They are hoping to enroll 1180 individuals at 2 locations."

Answered by AI

Does the FDA condone Spinal Manipulation Therapy as an effective treatment?

"Spinal Manipulation Therapy (SMT) has some efficacy data supporting it and multiple rounds of safety trials, so it received a score of 3."

Answered by AI

What are the goals that this medical research is aiming to achieve?

"The goal of this trial is to observe a reduction in pain levels over the course of 10-12 months. Additionally, researchers will be monitoring for changes in self-reported coping mechanisms, self-efficacy, and frequency of low back pain episodes."

Answered by AI

How many guinea pigs are testing this new drug?

"That is correct. Presently, the clinical trial mentioned is seeking participants. According to the data on clinicaltrials.gov, the trial was first posted on 10/25/2018 and was last edited on 7/12/2022. The trial is looking for 1180 participants between 2 sites."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
University of Pittsburgh
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I want to find a cure lot at least a way to help it not hurt so bad.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain
2018. "Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03581123.
All > Acute Pain > Lower Back Pain
~0 spots leftby Jun 2024
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