Lipomatosis, Low Back Pain
Conditions
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.
Interventions
DEVICESpinal Cord Stimulator
SOC Implantation of Spinal Cord Stimulator for Lipomatosis and Low Back Pain.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS-Visual Analog Scale- score of combined back and leg pain at 6 weeks follow-up. | 6 weeks | 0 meaning No Pain, 10 being worst possible pain. Higher pain means worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in VAS-Visual Analog Scale- score of low back pain. | 6 months, 12 months | 0 meaning No Pain, 10 being worst possible pain. Higher pain score means worse outcome. |
| Change in VAS-Visual Analog Scale - score of leg pain score | 6 months, 12 months | 0 meaning No Pain, 10 being worst possible pain. Higher pain score means worse outcome. |
| Change in Oswestry Disability Index. | 6 weeks, 6 months, 12 months | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSalim Hayek, MD
University Hospitals Cleveland Medical Center
Outcome results
None listed