Skip to main content
OpenTrials
Completed

NCT Number: NCT05811143

Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lipomatosis Back Pain Lipid Metabolism Disorders Low Back Pain Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals, Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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

Exclusion criteria

  • 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.

Treatment and study plan

Spinal cord stimulator

Device

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

Primary outcomes

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

    Time frame: 6 weeks

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

Secondary outcomes

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

    Time frame: 6 months, 12 months

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

  2. Change in VAS-Visual Analog Scale - score of leg pain score

    Time frame: 6 months, 12 months

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

  3. Change in Oswestry Disability Index.

    Time frame: 6 weeks, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2023
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.