Spinal Cord Stimulation (SCS) Therapy Study

Failed Back Surgery Syndrome Clinical Trial

Official title:

Spinal Cord Stimulation (SCS) Therapy Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02371122
• Other study ID #: 1673
• Status: Withdrawn
• Phase: N/A
• First received: February 19, 2015
• Last updated: July 9, 2015
• Start date: June 2015
• Est. completion date: January 2017

Study information

• Verified date: July 2015
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arachnoiditis
• Degenerative Disk Disease
• Epidural Fibrosis
• Failed Back Surgery Syndrome
• Intervertebral Disc Degeneration
• Radiculopathies
• Radiculopathy

Intervention

Device:
• Therapy Setting 1 (Medtronic)
RestoreSensor or RestoreUltra Setting 1
• Therapy Setting 2 (Medtronic)
Medtronic RestoreSensor or RestoreUltra Setting 2
• Therapy Setting 3 (Medtronic)
Medtronic RestoreSensor or RestoreUltra Setting 3
• Therapy Setting 4 (Medtronic)
Medtronic RestoreSensor or RestoreUltra Setting 4

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale - Leg pain		12 weeks	No
Secondary	Brief Pain Inventory - Pain severity		12 weeks	No
Secondary	Brief Pain Inventory - Pain interference		12 weeks	No
Secondary	Quantitative Sensory Testing - Vibration threshold		12 weeks	No
Secondary	Quantitative Sensory Testing - Electrical stimuli tolerance		12 weeks	No
Secondary	Numeric Pain Rating Scale - Back pain		12 weeks	No