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OpenTrials
Completed

NCT Number: NCT01874899

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

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.

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Key information

Conditions

Chronic Refractory Low Back and Leg Pain

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boulder Neurosurgical Associates

Boulder, Colorado, 80302, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RestoreSensor Neurostimulation

Device

Primary outcomes

  1. Stimulation amplitude changes in response to postural changes

    Time frame: 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 outcomes

  1. Sleep quality improvement

    Time frame: 6 months

    Pittsburg Sleep Quality Index Oswestry Disability Index

Other outcomes

  1. Disability score improvement

    Time frame: 6 months

    Oswestry Disability Index

  2. Pain scores

    Time frame: 6 months

    Numeric pain scale

  3. Patient satisfaction

    Time frame: 6 months

    Likert scale

Sponsors and collaborators

Lead sponsor

Justin Parker Neurological Institute

Other

Registry information

Acronym: RestoreSensor

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 11, 2013
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.