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

Completed

• Conditions: Chronic Refractory Low Back and Leg Pain
• Interventions: Device: RestoreSensor Neurostimulation

• Registration Number: NCT01874899
• Lead Sponsor: Justin Parker Neurological Institute

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Automatic, then Manual Stimulation	RestoreSensor Neurostimulation	The RestoreSensor neurostimulator will be programed for automatic stimulation adjustments and the patients will crossover to manual stimulation group after 1.5 months.
Manual, then Automatic Stimulation	RestoreSensor Neurostimulation	The RestoreSensor neurostimulator will be programed for manual stimulation adjustments and the patients will crossover to automatic stimulation group after 1.5 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Sleep quality improvement	6 months	Pittsburg Sleep Quality Index Oswestry Disability Index

Trial Locations

Locations (1)

Boulder Neurosurgical Associates; 🇺🇸 Boulder, Colorado, United States