Spinal Manipulation + Self-Management for Back Pain
(PACBACK Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
GB
Overseen byGert Bronfort, PhD, DC
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: University of Minnesota
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a study of adults with acute low back pain flare-up at risk of becoming chronic and disabling. The study tests how well spinal manipulation and guided selfcare work compared to standard medical care. The treatments last up to eight weeks and participants will be followed for one year.
Research Team
GB
Gert Bronfort, PhD, DC
Principal Investigator
University of Minnesota
Eligibility Criteria
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.Inclusion Criteria
I am 18 years old or older.
You are at medium or high risk for having long-lasting back pain based on the STarT Back screening tool.
Ability to read and write fluently in English
See 2 more
Exclusion Criteria
My low back pain is not due to a physical injury.
I have no medical conditions that prevent me from receiving the study treatments.
Pregnancy, current or planned during study period and nursing mothers
See 3 more
Treatment Details
Interventions
- SMT + SSM (Combination Product)
- Spinal Manipulation Therapy (SMT) (Procedure)
- Standard Medical Care (SMC) (Other)
- Supported-Self Management (SSM) (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
University of WashingtonSeattle, WA
University of MinnesotaMinneapolis, MN
University of PittsburghPittsburgh, PA
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Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Trials
1459
Patients Recruited
1,623,000+
University of North Texas Health Science Center
Collaborator
Trials
41
Patients Recruited
20,800+
Oregon Health and Science University
Collaborator
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1024
Patients Recruited
7,420,000+
Duke University
Collaborator
Trials
2495
Patients Recruited
5,912,000+
University of Pittsburgh
Collaborator
Trials
1820
Patients Recruited
16,360,000+
University of Washington
Collaborator
Trials
1858
Patients Recruited
2,023,000+