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Spinal Stimulation to Treat Low Back Pain

Extraforaminal Spinal Stimulation Compared to Conventional Spinal Cord Stimulation to Treat Axial Low Back Pain-A Pilot Study

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02128672
Enrollment
0
Registered
2014-05-01
Start date
2015-07-31
Completion date
2015-12-31
Last updated
2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Lumbago, Lumbar Back Pain

Brief summary

Spinal cord stimulation (SCS) has been used for almost 30 years to treat many intractable back pain conditions. It has demonstrated efficacy in the co-called Failed Back Surgery Syndrome (FBSS) and a recent randomized controlled trial demonstrated significant superiority of SCS over conventional medical therapy to treat patients with FBSS. Another trial has demonstrated superiority of SCS over repeat surgery in the same patient population. However, the ability to reliably capture the low back with paresthesia coverage has remained challenging and elusive despite numerous strategies designed to overcome this limitation. Strategies that have been introduced but so far with limited success include transverse multiple lead stimulation, high frequency stimulation, peripheral field stimulation, and dorsal root ganglion (DRG) stimulation. To date, none of these strategies have been able to reliably overcome the long-term problems of paresthesia capture and pain relief of the low back. This proposal describes a new spinal stimulation technique designed to improve the likelihood of low back stimulation by targeting the nerve supply to the two most commonly affected pain producing structures in the back, the facet joints and the intervertebral disks. The technique has proven to be feasible in a cadaver model with ease of lead placement at the desired targets

Interventions

PROCEDURESpinal Cord Stimulator Lead Placement

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion: * Patients with one sided low back pain * Failed standard conservative care including medications, physical therapy, and/or injections * Pain greater than 6 months Exclusion: * Pregnancy * Previous spine surgery * Pain radiating beyond/below the knee

Design outcomes

Primary

MeasureTime frameDescription
Did the participant have paresthesia coverage from the stimulation?Baseline to 4 daysThis is a simple yes or no outcome. Either the patient is able to feel the stimulation paresthesia in the area of his or her back where he or she has pain (outcome is yes) or they do not feel it (outcome is no).

Secondary

MeasureTime frameDescription
Numeric Pain Rating Scale (NRS)Baseline to 4 daysNRS is a validated back pain outcome scale
Patient preferred stimulation-Likert Scalebaseline to 4 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026