Clinical trial NCT02371122: Spinal Cord Stimulation (SCS) Therapy Study
Official title: Spinal Cord Stimulation (SCS) Therapy Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Failed Back Surgery Syndrome
Degenerative Disk Disease
Epidural Fibrosis
Arachnoiditis
Radiculopathies
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2015-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Numeric Pain Rating Scale - Leg pain
timeFrame: 12 weeks
Secondary outcomes:
measure: Brief Pain Inventory - Pain severity
timeFrame: 12 weeks
measure: Brief Pain Inventory - Pain interference
timeFrame: 12 weeks
measure: Quantitative Sensory Testing - Vibration threshold
timeFrame: 12 weeks
measure: Quantitative Sensory Testing - Electrical stimuli tolerance
timeFrame: 12 weeks
measure: Numeric Pain Rating Scale - Back pain
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: