Spinal Cord Stimulation (SCS) Therapy Study

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.

Study Overview

• Status: Withdrawn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

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RestoreSensor or RestoreUltra Setting 1; Therapy Setting 1	Device: Therapy Setting 1 (Medtronic); RestoreSensor or RestoreUltra Setting 1
Active Comparator: RestoreSensor or RestoreUltra Setting 2; Therapy Setting 2	Device: Therapy Setting 2 (Medtronic); Medtronic RestoreSensor or RestoreUltra Setting 2
Active Comparator: RestoreSensor or RestoreUltra Setting 3; Therapy Setting 3	Device: Therapy Setting 3 (Medtronic); Medtronic RestoreSensor or RestoreUltra Setting 3
Sham Comparator: RestoreSensor or RestoreUltra Setting 4; Therapy Setting 4	Device: Therapy Setting 4 (Medtronic); Medtronic RestoreSensor or RestoreUltra Setting 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Numeric Pain Rating Scale - Leg pain	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: MedtronicNeuro

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: February 19, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): February 25, 2015

Study Record Updates

• Last Update Posted (Estimate): July 10, 2015
• Last Update Submitted That Met QC Criteria: July 9, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Bone Diseases; Back Pain; Meningitis; Intervertebral Disc Degeneration; Radiculopathy; Failed Back Surgery Syndrome; Arachnoiditis
• Other Study ID Numbers: 1673