NCT05811143

Brief Summary

The specific aims of this proposal are to: Examining the effects of dorsal column stimulation on pain from lumbar spinal stenosis related to lumbar epidural lipomatosis. The primary outcome will be improvement in VAS score of combined back and leg pain at 6 weeks follow-up. Secondary outcomes will include improvement in Visual Analog Scale (VAS) back pain scores, VAS leg pain scores, and Oswestry Disability Index (ODI) , as well as SCS complication rate. The specific aims of this proposal are to: Examining the effects of dorsal column stimulation on pain from lumbar spinal stenosis related to lumbar epidural lipomatosis. The primary outcome will be improvement in VAS score of combined back and leg pain at 6 weeks follow-up. Secondary outcomes will include improvement in VAS back pain scores, VAS leg pain scores, and Oswestry Disability Index, as well as SCS complication rate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2020

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

March 20, 2023

Last Update Submit

January 30, 2026

Conditions

LipomatosisLow Back Pain

Outcome Measures

Primary Outcomes (1)

  • VAS-Visual Analog Scale- score of combined back and leg pain at 6 weeks follow-up.

    0 meaning No Pain, 10 being worst possible pain. Higher pain means worse outcome.

    6 weeks

Secondary Outcomes (3)

  • Change in VAS-Visual Analog Scale- score of low back pain.

    6 months, 12 months

  • Change in VAS-Visual Analog Scale - score of leg pain score

    6 months, 12 months

  • Change in Oswestry Disability Index.

    6 weeks, 6 months, 12 months

Interventions

Spinal Cord StimulatorDEVICE

SOC Implantation of Spinal Cord Stimulator for Lipomatosis and Low Back Pain.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Up to 20 subjects who present to University Hospital Pain Medicine clinics

You may qualify if:

  • \- Have chronic pain for \>3 months
  • Age 18-65 years
  • Have been scheduled to be implanted with the spinal cord stimulator due to epidural lipomatosis.
  • MRI evidence of lumbar spinal stenosis with grade I-III Lumbar epidural lipomatosis and concordant history and physical examination

You may not qualify if:

  • No evidence of lumbar epidural lipomatosis based on MRI 2. Presence of a pacemaker/ICD (to avoid possible side-effects of electrical stimulation) 3. Coagulopathy (either non-pharmacological or unable to discontinue anticoagulation due to underlying comorbidities as deemed by prescribing physician) 4. Unable to follow commands or provide consent. 5. Are not medically/psychologically stable 6. Have clinical/EMG documented motor dysfunction and have not been evaluated by spine surgeon. 7. Inappropriate surgical candidates as determined by the individual implanting physician. 8. History of laminectomy/fusion in thoracic or lumbar spine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals, Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

LipomatosisLow Back Pain

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Salim Hayek, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 13, 2023

Study Start

September 22, 2020

Primary Completion

January 25, 2024

Study Completion

January 25, 2024

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)