Spinal Decompression Therapy for Lower Back Pain

(RESTORE Trial)

Recruiting at 1 trial location

Overseen By Evan Weisman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: Serious spinal pathology, Pregnancy, Spinal fusion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

Duration: 6-8 weeks

42 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is non-surgical spinal decompression therapy safe for humans?

The research does not provide specific safety data for non-surgical spinal decompression therapy, but it is often grouped with other non-surgical treatments for low back pain, which are generally considered safe. However, the safety of spinal manipulative therapy, a related treatment, has conflicting reviews regarding serious adverse events. ^{1 2 3 4 5}

How is non-surgical spinal decompression therapy different from other treatments for lower back pain?

Non-surgical spinal decompression therapy is unique because it uses a motorized device to gently stretch the spine, aiming to reduce pressure on spinal discs and promote healing, which can help restore disc height and alleviate pain. This approach is different from other treatments like medication or surgery, as it focuses on mechanical decompression to address the root cause of disc-related back pain. ^{6 7 8 9 10}

What is the purpose of this trial?

This project will determine the clinical utility of non-surgical spine decompression for chronic low back pain (LBP). LBP is one of the highest incidence medical conditions that contributes to disability, decreased activities of daily living, decreased quality of life, and inability to work. LBP affects ≈70-85% of people during their lifetime, with ≈20% becoming chronic by age 20-59 years. Many current LBP therapeutics have detrimental long-term effects, undesired side effects, are invasive procedures with low success rates, and do not fare better than conservative care. Further, many chronic musculoskeletal pain patients do not respond to surgery, and many develop dependence on opioids. This project will implement a small-scale double-blinded, randomized proof-of-concept clinical trial to gather biomechanical and MRI data that will objectively determine the effectiveness of non-surgical spinal decompression (NSSD) over a 12-week longitudinal timeframe. The potential to provide a non-invasive alternative to chronic LBP via NSSD is innovative and addresses the pressing need for safer, more effective pain management options with fewer negative sequelae. NSSD has the potential to greatly improve lives, offering a new paradigm for chronic pain management.

Research Team

Nathan D Schilaty, DC, PhD

Principal Investigator

University of South Florida

Eligibility Criteria

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.

Inclusion Criteria

I have had lower back pain for over 3 months due to a disc or sciatica issue.

Exclusion Criteria

I have a long-term pain condition.

Pregnancy

I have a serious spine condition like a fracture, tumor, or osteoporosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Comprehensive baseline assessment including chiropractic examination and MRI if needed

1 week

1 visit (in-person)

Randomization and Pre-intervention Assessments

Participants are randomized to treatment groups and undergo pre-intervention assessments

1 week

1 visit (in-person)

Treatment

Participants receive non-surgical spinal decompression or sham treatment (20 sessions over 6-8 weeks)

6-8 weeks

20 visits (in-person)

Post-intervention Assessments

Assessments after intervention to evaluate outcomes

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Non-surgical Spinal Decompression Therapy

Trial Overview 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.

Participant Groups

Group I: NSSD Experimental Treatment 1 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 NSSD Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

U.S. Army Medical Research and Development Command

Collaborator

Trials

296

Recruited

249,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Findings from Research

There is limited scientific evidence supporting the routine use of non-surgical spinal decompression therapy for low back pain, with only one small randomized controlled trial and several lower-quality studies available.

Many marketing claims for spinal decompression therapy are based on studies that do not accurately reflect the therapy's application, as they often use different patient positioning than what is marketed, raising concerns about the validity of these claims.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-surgical spinal decompression therapy: does the scientific literature support efficacy claims made in the advertising media? Daniel, DM.[2022]

A study analyzing health insurance claims in New Hampshire found that adults receiving chiropractic services for low back pain had a 51% lower likelihood of experiencing adverse drug events (ADEs) compared to those who did not use chiropractic care.

While the study indicates a significant association between chiropractic service utilization and reduced risk of ADEs, it does not establish a causal relationship, highlighting the need for further research with larger datasets and improved methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Utilization of Chiropractic Services for Treatment of Low Back Pain and Risk of Adverse Drug Events. Whedon, JM., Toler, AWJ., Goehl, JM., et al.[2019]

A systematic review of 283 reviews on spinal manipulative therapy (SMT) found that while 46% deemed SMT safe, 13% considered it harmful, indicating a significant divide in opinions on its safety.

Serious adverse events (SAEs) associated with SMT, such as stroke and vertebral artery dissection, were reported, with incidence estimates ranging from 1 in 20,000 to 1 in 250,000,000 manipulations, highlighting that some risk is present.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The risk associated with spinal manipulation: an overview of reviews. Nielsen, SM., Tarp, S., Christensen, R., et al.[2022]

In a study involving 30 young adults with low back pain, nonsurgical spinal decompression (NSSD) did not result in immediate changes to the mechanical properties or thickness of the paraspinal muscles after treatment.

The findings suggest that the benefits of NSSD may arise from stimulating mechanical receptors rather than altering muscle structure or properties, indicating that traditional measures of muscle morphology may not be effective for assessing NSSD outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of nonsurgical spinal decompression on paraspinal muscle morphology and mechanical properties in young adults with low back pain. Lo, WLA., Lei, D., Leng, Y., et al.[2021]

The North American Spine Society has created a special issue in The Spine Journal to provide clear, evidence-based information on various nonsurgical treatments for chronic low back pain (CLBP), addressing the challenges faced by patients and healthcare providers in selecting appropriate therapies.

This issue includes contributions from leading experts summarizing the efficacy, potential harms, and theoretical basis of 24 different nonsurgical interventions, aiming to facilitate informed decision-making among stakeholders involved in CLBP management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-informed management of chronic low back pain with medicine-assisted manipulation. Dagenais, S., Mayer, J., Wooley, JR., et al.[2022]

In a study of 30 patients with chronic low back pain due to disc herniation, a 6-week treatment with motorized non-surgical spinal decompression significantly reduced pain levels from an average of 6.2 to 1.6 on a verbal rating scale.

The treatment also led to an increase in lumbar disc height from 7.5 mm to 8.8 mm, with a significant correlation between the reduction in pain and the increase in disc height, suggesting that pain relief may be linked to disc regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoration of disk height through non-surgical spinal decompression is associated with decreased discogenic low back pain: a retrospective cohort study. Apfel, CC., Cakmakkaya, OS., Martin, W., et al.[2022]

In a study of 20 patients with lumbar disc herniation, both non-invasive spinal decompression therapy (NSDT) and standard physiotherapy showed positive effects on pain relief and functional improvement after treatment.

While NSDT led to a greater reduction in herniation size compared to the control group, the differences were not statistically significant, suggesting that NSDT can be a helpful addition to standard physiotherapy but may not be superior on its own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regression of lumbar disc herniation by physiotherapy. Does non-surgical spinal decompression therapy make a difference? Double-blind randomized controlled trial. Demirel, A., Yorubulut, M., Ergun, N.[2018]

In a study of 31 participants with chronic lumbar disc prolapse, spinal decompression therapy (SDT) combined with core stabilization exercises (CSE) resulted in significantly greater reductions in pain and functional disability compared to CSE alone.

Both treatment groups showed improvements, but the SDT with CSE group had a mean pain reduction of 4.75 and a disability reduction of 45.13, indicating that SDT enhances the effectiveness of CSE in managing chronic lumbar disc issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of spinal decompression therapy and core stabilization exercises in management of lumbar disc prolapse: A single blind randomized controlled trial. Gaowgzeh, RAM., Chevidikunnan, MF., BinMulayh, EA., et al.[2020]

Nonsurgical interventional spine pain procedures, such as epidural steroid injections and spinal cord stimulation, are effective and safe options for treating lower back pain, providing an alternative to surgery.

Some techniques, like thermal annuloplasty and lumbar decompression, showed mixed results, while others, such as discography and sacroiliac joint injections, did not have enough evidence to support their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonsurgical Interventional Spine Pain Procedures: Outcomes and Complications. Whitaker, CD., Stone, BK., Gregorczyk, JA., et al.[2023]

In a study of 203 patients with degenerative spondylolisthesis, comprehensive non-surgical treatment (CNT) effectively reduced the need for surgery, with only 21.6% of patients with degenerative spondylolisthesis and 31.3% with spondylolytic spondylolisthesis opting for surgery after 3 years.

Patients receiving CNT reported significantly better pain relief and longer-lasting effects from transforaminal epidural steroid injections compared to those who underwent surgery, suggesting that CNT can be a successful alternative to surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive non-surgical treatment decreased the need for spine surgery in patients with spondylolisthesis: Three-year results. Demir-Deviren, S., Ozcan-Eksi, EE., Sencan, S., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Non-surgical spinal decompression therapy: does the scientific literature support efficacy claims made in the advertising media? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Association Between Utilization of Chiropractic Services for Treatment of Low Back Pain and Risk of Adverse Drug Events. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The risk associated with spinal manipulation: an overview of reviews. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Impact of nonsurgical spinal decompression on paraspinal muscle morphology and mechanical properties in young adults with low back pain. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Evidence-informed management of chronic low back pain with medicine-assisted manipulation. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Restoration of disk height through non-surgical spinal decompression is associated with decreased discogenic low back pain: a retrospective cohort study. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Regression of lumbar disc herniation by physiotherapy. Does non-surgical spinal decompression therapy make a difference? Double-blind randomized controlled trial. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of spinal decompression therapy and core stabilization exercises in management of lumbar disc prolapse: A single blind randomized controlled trial. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Nonsurgical Interventional Spine Pain Procedures: Outcomes and Complications. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Comprehensive non-surgical treatment decreased the need for spine surgery in patients with spondylolisthesis: Three-year results. [2020]