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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811143
• Other study ID #: STUDY20200036
• Status: Recruiting
• Start date: September 22, 2020
• Est. completion date: September 22, 2024

Study information

• Verified date: April 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: Mario Becerra, RN
• Phone: 216-844-1734
• Email: Mario.Becerra[@]UHHospitals.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 22, 2024
• Est. primary completion date: September 22, 2024
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Low Back Pain
• Spinal Stenosis

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals, Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS-Visual Analog Scale- score of combined back and leg pain at 6 weeks follow-up.	0 meaning No Pain, 10 being worst possible pain. Higher pain means worse outcome.	6 weeks
Secondary	Change in VAS-Visual Analog Scale- score of low back pain.	0 meaning No Pain, 10 being worst possible pain. Higher pain score means worse outcome.	6 months, 12 months
Secondary	Change in VAS-Visual Analog Scale - score of leg pain score	0 meaning No Pain, 10 being worst possible pain. Higher pain score means worse outcome.	6 months, 12 months
Secondary	Change in Oswestry Disability Index.		6 weeks, 6 months, 12 months