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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, pre-intervention; immediately after intervention

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.

0 / 4Eligibility criteria met