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Chiropractic Care for Lower Back Pain (VERDICT Trial)

N/A
Waitlist Available
Led By Christine Goertz, DC, PhD
Research Sponsored by Palmer College of Chiropractic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnostic confirmation of neuromusculoskeletal LBP
Veterans aged ≥ 18 years
Must not have
Any condition prohibiting or contraindicating chiropractic care
Under active chiropractic care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and weeks 5, 10, 26, 40, and 52
Awards & highlights
No Placebo-Only Group

Summary

This trial is to study how effective different doses of chiropractic care are for chronic low back pain and how health services utilization is impacted.

Who is the study for?
This trial is for Veterans aged 18 or older with chronic low back pain who can attend chiropractic sessions for up to a year. They must understand the study, not be under current chiropractic care, and not planning to move within three months. Those with conditions that prohibit chiropractic care or are in other pain treatment studies cannot join.
What is being tested?
The study tests how different doses of chiropractic therapy affect chronic low back pain in Veterans over two phases: one group gets a lower dose (1-5 visits) and another gets higher (8-12 visits) for 10 weeks. Afterwards, they may receive monthly care or no further treatment for ten months.
What are the potential side effects?
Chiropractic care generally has minimal side effects but can include temporary discomfort at the site of adjustment, fatigue, or headache. Serious side effects are rare but could involve nerve damage or worsening pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lower back pain is confirmed to be from a nerve, muscle, or skeletal issue.
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I am a veteran and 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any health issues that prevent me from receiving chiropractic care.
Select...
I am currently seeing a chiropractor.
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I am currently in or planning to enter hospice care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and weeks 5, 10, 26, 40, and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and weeks 5, 10, 26, 40, and 52 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 from Baseline Low Back Pain Disability at several time points - Roland Morris Disability Questionnaire (RMDQ)
Secondary study objectives
Healthcare Services Utilization

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Active Control
Group I: Phase 1: Low Dose (1-5 visits)Active Control1 Intervention
Veterans with cLBP who will be randomly allocated to undergo a course of a low dose (1-5 visits) of multimodal, evidence-based chiropractic care for 10 weeks (Phase 1).
Group II: Phase 1: Higher Dose (8-12 visits)Active Control1 Intervention
Veterans with cLBP who will be randomly allocated to undergo a course of a higher dose (8-12 visits) of multimodal, evidence-based chiropractic care for 10 weeks (Phase 1).
Group III: Phase 2: CCPMActive Control1 Intervention
After Phase 1, Veterans with cLBP who will be randomly allocated again to receive chiropractic chronic pain management (CCPM) consisting of scheduled monthly chiropractic care for 10 months.
Group IV: Phase 2: No CCPMActive Control1 Intervention
After Phase 1, Veterans with cLBP who will be randomly allocated again to receive no CCPM in which they will receive no chiropractic care for 10 months.

Find a Location

Who is running the clinical trial?

Yale UniversityOTHER
1,924 Previous Clinical Trials
3,030,892 Total Patients Enrolled
4 Trials studying Low Back Pain
334 Patients Enrolled for Low Back Pain
Office of Research on Women's Health (ORWH)NIH
32 Previous Clinical Trials
35,345 Total Patients Enrolled
3 Trials studying Low Back Pain
1,094 Patients Enrolled for Low Back Pain
VA Greater Los Angeles Healthcare SystemFED
51 Previous Clinical Trials
7,651 Total Patients Enrolled

Media Library

Chiropractic Care Clinical Trial Eligibility Overview. Trial Name: NCT04087291 — N/A
Low Back Pain Research Study Groups: Phase 1: Low Dose (1-5 visits), Phase 1: Higher Dose (8-12 visits), Phase 2: CCPM, Phase 2: No CCPM
Low Back Pain Clinical Trial 2023: Chiropractic Care Highlights & Side Effects. Trial Name: NCT04087291 — N/A
Chiropractic Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04087291 — N/A
~77 spots leftby May 2025