Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads

NCT01874899 | Completed

• 1 other identifier: JPNI-3
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Refractory Low Back and Leg Pain

Outcome Measures

Primary Outcomes (1)

• Stimulation amplitude changes in response to postural changes

  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.

  6 months

Secondary Outcomes (1)

• Sleep quality improvement

  6 months

Other Outcomes (3)

• Disability score improvement

  6 months

• Pain scores

  6 months

• Patient satisfaction

  6 months

Study Arms (2)

Manual, then Automatic Stimulation

The RestoreSensor neurostimulator will be programed for manual stimulation adjustments and the patients will crossover to automatic stimulation group after 1.5 months

Device: RestoreSensor Neurostimulation

Automatic, then Manual Stimulation

The RestoreSensor neurostimulator will be programed for automatic stimulation adjustments and the patients will crossover to manual stimulation group after 1.5 months.

Device: RestoreSensor Neurostimulation

Interventions

RestoreSensor Neurostimulation DEVICE

Automatic, then Manual Stimulation; Manual, then Automatic Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with chronic refractory back and leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions.

You may qualify if:

• 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

You may not qualify if:

• Previous SCS treatment
• Surgically remediable spinal condition
• Active local or systemic infection

Sponsors & Collaborators

• Justin Parker Neurological Institute: lead

Study Sites (1)

Boulder Neurosurgical Associates

Boulder, Colorado, 80302, United States

Location

Study Officials

• Kara Beasley, DO

  Boulder Neurosurgical Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 11, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

US (1)