Spinal Cord Stimulation (SCS) Therapy Study

Not Applicable

Withdrawn

• Conditions: Degenerative Disk Disease; Failed Back Surgery Syndrome; Epidural Fibrosis; Arachnoiditis; Radiculopathies
• Interventions: Device: Therapy Setting 4 (Medtronic); Device: Therapy Setting 1 (Medtronic); Device: Therapy Setting 2 (Medtronic); Device: Therapy Setting 3 (Medtronic)

• Registration Number: NCT02371122
• Lead Sponsor: MedtronicNeuro

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-02-25
• Study Start: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-10
• Primary Completion: 2016-11
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Pregnant or lactating, inadequate birth control, or at risk of pregnancy during this study

• Has an untreated psychiatric comorbidity

• Has serious drug-related behavioral issues

• Has active malignancy or has been diagnosed with cancer and has not been in remission for at least one year

• Has secondary gains which, in the opinion of the investigator, are likely to interfere with the study

• Participating or planning to participate in another clinical trial while enrolled in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RestoreSensor or RestoreUltra Setting 4	Therapy Setting 4 (Medtronic)	Therapy Setting 4
RestoreSensor or RestoreUltra Setting 1	Therapy Setting 1 (Medtronic)	Therapy Setting 1
RestoreSensor or RestoreUltra Setting 2	Therapy Setting 2 (Medtronic)	Therapy Setting 2
RestoreSensor or RestoreUltra Setting 3	Therapy Setting 3 (Medtronic)	Therapy Setting 3

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale - Leg pain	12 weeks

Secondary Outcome Measures

Name	Time	Method
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