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Clinical Trials/NCT02371122
NCT02371122
Withdrawn
N/A

Spinal Cord Stimulation (SCS) Therapy Study

MedtronicNeuro0 sitesJune 2015
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ConditionsFailed Back Surgery SyndromeDegenerative Disk DiseaseEpidural FibrosisArachnoiditisRadiculopathies

Overview

Phase
N/A
Intervention
Not specified
Conditions
Failed Back Surgery Syndrome
Sponsor
MedtronicNeuro
Primary Endpoint
Numeric Pain Rating Scale - Leg pain
Status
Withdrawn
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the effect of different spinal cord stimulation settings in the treatment of leg pain. Subjects will receive a randomized order of four different programmed stimulation settings for 3 weeks each followed by a fifth and final setting.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
January 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •At least 22 years of age or older at the time of informed consent
  • •Implanted with a Medtronic RestoreSensor or RestoreUltra SCS system for an on-label indication at least 6 months for the treatment of chronic leg pain, with or without back pain
  • •Implanted with one or more Medtronic leads located in the epidural space within the thoracic area
  • •Receiving some level of pain relief with current SCS therapy
  • •On a stable dose (no new, discontinued or changes in) of all prescription pain medications and willing to maintain or only decrease the dose of all prescribed pain medications
  • •Read and understand English without assistance
  • •Willing and able to comply with all study procedures, study visits, and be available for the duration of the study

Exclusion Criteria

  • •Diagnosed with complex regional pain syndrome (CRPS), peripheral causalgia, or reflex sympathetic dystrophy (RSD), or causalgia
  • •Has leg, knee, or foot pain unrelated to on-label indication for SCS therapy (for eg, arthritis, knee surgery, etc.)
  • •Implanted with both a surgical and percutaneous lead
  • •Implanted with a peripheral lead for subcutaneous or peripheral nerve stimulation
  • •Has had any of the following procedures:
  • •Neuroablative procedure within six months
  • •Neurolytic block within two months
  • •Injection therapy for pain within four weeks
  • •Sympathetic block within two weeks
  • •Has an active implanted device (besides RestoreUltra or RestoreSensor neurostimulator), whether turned ON or OFF

Outcomes

Primary Outcomes

Numeric Pain Rating Scale - Leg pain

Time Frame: 12 weeks

Secondary Outcomes

  • Brief Pain Inventory - Pain severity(12 weeks)
  • Brief Pain Inventory - Pain interference(12 weeks)
  • Quantitative Sensory Testing - Vibration threshold(12 weeks)
  • Quantitative Sensory Testing - Electrical stimuli tolerance(12 weeks)
  • Numeric Pain Rating Scale - Back pain(12 weeks)

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