Enhanced Physical Therapy for Chronic Lower Back Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, COChronic Lower Back PainSpinal Manipulation Therapy (SMT) - Procedure
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether an enhanced physical therapy intervention, combining pain self-management education with a tailored exercise program, can reduce pain interference more than internet-based pain self-management or usual care in Veterans with chronic low back pain.

Eligible Conditions
  • Chronic Lower Back Pain

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 3 months post-treatment

3 months post-treatment
Brief Pain Inventory (BPI) Interference scale

Trial Safety

Trial Design

6 Treatment Groups

Enhanced Physical Therapy
1 of 6
Spinal Manipulation Therapy (SMT)
1 of 6
Internet-based pain self-management program
1 of 6
Cognitive Behavioral Therapy (CBT)
1 of 6
Yoga
1 of 6
Continued Care and Active Monitoring (CCAM)
1 of 6

Active Control

Non-Treatment Group

2529 Total Participants · 6 Treatment Groups

Primary Treatment: Enhanced Physical Therapy · Has Placebo Group · N/A

Continued Care and Active Monitoring (CCAM)
Other
PlaceboComparator Group · 1 Intervention: Continued Care and Active Monitoring · Intervention Types: Other
Enhanced Physical TherapyActiveComparator Group · 2 Interventions: Pain EASE, Tailored exercise · Intervention Types: Other, Procedure
Spinal Manipulation Therapy (SMT)
Procedure
ActiveComparator Group · 1 Intervention: Spinal Manipulation Therapy (SMT) · Intervention Types: Procedure
Internet-based pain self-management program
Other
ActiveComparator Group · 1 Intervention: Pain EASE · Intervention Types: Other
Cognitive Behavioral Therapy (CBT)
Behavioral
ActiveComparator Group · 1 Intervention: Cognitive Behavioral Therapy (CBT) · Intervention Types: Behavioral
Yoga
Procedure
ActiveComparator Group · 1 Intervention: Yoga · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months post-treatment

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,500 Previous Clinical Trials
2,722,482 Total Patients Enrolled
David J Clark, PhD MDStudy ChairVA Palo Alto Health Care System, Palo Alto, CA
Matthew J. Bair, MD MSStudy ChairRichard L. Roudebush VA Medical Center, Indianapolis, IN
4 Previous Clinical Trials
1,125 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Nevada33.3%
California16.7%
Tennessee16.7%
Other33.3%
How old are they?
65+100.0%
What site did they apply to?
VA Palo Alto Health Care System, Palo Alto, CA33.3%
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD33.3%
VA Southern Nevada Healthcare System, North Las Vegas, NV33.3%
What portion of applicants met pre-screening criteria?
Met criteria71.4%
Did not meet criteria28.6%
Why did patients apply to this trial?
  • "i want to get rid of my chronic back pain"
  • "I have had lower back pain for years and it is affecting me being able to stand and walk comfortably with out pain and major discomfort"
  • "I have numerous issues with my lower back. I am a US Navy veteran. I was an Aircrew(rescue swimmer) member, and ever since I was on active duty, I have been digressing and my mobility has decreased significantly. I am going through issues with walking and being in pain constantly 8 out of ten. also currently"
How many prior treatments have patients received?
025.0%
250.0%
3+25.0%

Frequently Asked Questions

In how many distinct locations is this medical trial taking place?

"This clinical trial is currently being conducted in 21 distinct sites, including Salisbury W.G. (Bill) Hefner VA Medical Center located in Salisbury, VA Portland Health Care System situated in Portland, OR and Richard L. Roudebush VA Medical Center found within Indianapolis IN., as well as many other locations around the US." - Anonymous Online Contributor

Unverified Answer

Can you confirm if enrollment is open for this clinical trial?

"The clinical trial is still open for applications, as evidenced by the information available on clinicaltrials.gov which was last updated in July of 2022 following its initial posting date in June." - Anonymous Online Contributor

Unverified Answer

What is the current intake capacity for participants in this clinical experiment?

"This randomized controlled trial requires 2,529 subjects that meet the pre-defined eligibility criteria. Potential participants can register at Salisbury W.G. (Bill) Hefner VA Medical Center in North Carolina or VA Portland Health Care System in Oregon." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.