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

University Hospitals (UH)

Status: Completed

Conditions: Low Back Pain; Lipomatosis

Treatments: Device: Spinal Cord Stimulator

Study type: Observational

Funder types: Other

Identifiers

NCT05811143

STUDY20200036

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. - Have chronic pain for >3 months
2. Age 18-65 years
3. Have been scheduled to be implanted with the spinal cord stimulator due to epidural lipomatosis.
4. 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.