Clinical trial NCT05811143: Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.
Official title: Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lipomatosis
Low Back Pain
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 20 subjects who present to University Hospital Pain Medicine clinics

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.


Eligibility criteria: 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.

Primary outcomes:
measure: VAS-Visual Analog Scale- score of combined back and leg pain at 6 weeks follow-up.
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in VAS-Visual Analog Scale- score of low back pain.
timeFrame: 6 months, 12 months
measure: Change in VAS-Visual Analog Scale - score of leg pain score
timeFrame: 6 months, 12 months
measure: Change in Oswestry Disability Index.
timeFrame: 6 weeks, 6 months, 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals, Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Salim Hayek, MD
role: PRINCIPAL_INVESTIGATOR
References: