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

Completed

• Conditions: Lipomatosis; Low Back Pain

• Registration Number: NCT05811143
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-22
• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-13
• Primary Completion: 2024-01-25
• Study Completion: 2024-01-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in Oswestry Disability Index.	6 weeks, 6 months, 12 months
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.

Trial Locations

Locations (1)

University Hospitals, Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States