Chronic Refractory Low Back and Leg Pain
Conditions
Brief summary
The main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type, leads experience position-related variation in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.
Detailed description
A single-center, prospective, randomized study with a two-arm crossover design. The primary objective of this study is to establish threshold and therapeutic stimulation parameters for the RestoreSensor neurostimulator in response to postural changes. The secondary objective is to compare the effectiveness of spinal cord stimulation with manual versus automatic position-adaptive settings for chronic refractory low back and/or extremity pain.
Interventions
DEVICERestoreSensor Neurostimulation
Sponsors
Justin Parker Neurological Institute
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Skeletally mature adults between 18 and 70 years old * Patients with chronic refractory back and/or leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions * \> 50% pain reduction during the trail period * Willing and able to comply with the requirements of the protocol including follow-up requirements * Willing to sign a study specific informed consent
Exclusion criteria
* Previous SCS treatment * Surgically remediable spinal condition * Active local or systemic infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stimulation amplitude changes in response to postural changes | 6 months | Threshold and therapeutic stimulation parameters in different postures: lying right, lying left, lying prone, lying supine, upright and upright active will be collected for manual and sensor-driven position-adaptive stimulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality improvement | 6 months | Pittsburg Sleep Quality Index Oswestry Disability Index |
Other
| Measure | Time frame | Description |
|---|---|---|
| Disability score improvement | 6 months | Oswestry Disability Index |
| Pain scores | 6 months | Numeric pain scale |
| Patient satisfaction | 6 months | Likert scale |
Countries
United States
Outcome results
None listed