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Procedure

Spinal Decompression Therapy for Lower Back Pain (RESTORE Trial)

N/A
Waitlist Available
Led By Nathan D Schilaty, DC, PhD
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of chronic LBP for a minimum of 3 months caused by pathological intervertebral disc, degenerative disc disease, posterior facet syndrome, and/or sciatica.
Be older than 18 years old
Must not have
Known serious spinal pathology (e.g., vertebral fracture, tumor, osteoporosis)
Evidence of central nervous system involvement of pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, pre-intervention; immediately after intervention
Awards & highlights

Summary

"This trial will investigate the effectiveness of non-surgical spine decompression for chronic low back pain. Low back pain is a common condition that can lead to disability and decreased quality of life. Many current treatments

Who is the study for?
This trial is for individuals with chronic low back pain due to conditions like herniated discs or spinal stenosis. Participants should have experienced back pain that affects their daily life and work, without finding relief from other treatments.
What is being tested?
The study tests non-surgical spinal decompression (NSSD) therapy against a sham (fake) treatment to see if NSSD can effectively reduce chronic lower back pain over a period of 12 weeks, using MRI data and biomechanical analysis.
What are the potential side effects?
Since the trial involves NSSD, which is non-invasive, side effects may be minimal compared to surgery or long-term medication use. However, specific side effects are not detailed in the provided information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had lower back pain for over 3 months due to a disc or sciatica issue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious spine condition like a fracture, tumor, or osteoporosis.
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I experience pain due to my condition affecting my brain or spinal cord.
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I have had spinal fusion surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, pre-intervention; immediately after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, pre-intervention; immediately after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
3D Motion Capture
Lumbar Spine Magnetic Resonance Imaging (MRI)
Myotonometer
+2 more
Secondary study objectives
Central Sensitization Inventory
DVPRS 2.0
Oswestry Disability Index
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NSSDExperimental Treatment1 Intervention
This group will receive non-surgical spinal decompression (20x over 6-8 weeks). Non-surgical spinal decompression is performed by securing the pelvis in a brace and stabilizing the upper torso. The decompression device provides an inferior force along a vector targeting the level of pathology by pulling on the pelvic brace. This causes a comfortable decompression of the spine.
Group II: Sham NSSDPlacebo Group1 Intervention
This group will receive sham non-surgical spinal decompression (20x over 6-8 weeks). Sham non-surgical spinal decompression is performed by securing the pelvis in a brace and stabilizing the upper torso. The decompression device provides an inferior force along a vector targeting the level of pathology by pulling on the pelvic brace, but at a force that does not cause decompression of the spine. This is not perceivable by the participant.

Find a Location

Who is running the clinical trial?

U.S. Army Medical Research and Development CommandFED
289 Previous Clinical Trials
246,029 Total Patients Enrolled
University of South FloridaLead Sponsor
422 Previous Clinical Trials
189,185 Total Patients Enrolled
Stanford UniversityOTHER
2,448 Previous Clinical Trials
17,492,352 Total Patients Enrolled
1 Trials studying Sciatica
24 Patients Enrolled for Sciatica
~28 spots leftby Aug 2026
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