Spinal Cord Stimulation Frequency Study

Medtronic

Status: Completed

Conditions: Failed Back Surgery Syndrome

Treatments: Device: 3030 Hz; Device: Sham; Device: 1200 Hz; Device: 5882 Hz

Study type: Interventional

Funder types: Industry

Identifiers

NCT01750229

1668

Details and patient eligibility

About

The purpose of this study is to evaluate the role of frequency settings on spinal cord stimulation in the management of Failed Back Surgery Syndrome (SCS Frequency Study).

Full description

Prospective, single-center, double-blinded, randomized crossover of 4 different stimulation frequencies: sham, 1200 Hz, 3030 Hz, and 5882 Hz.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years old at the time of informed consent
• Willing and able to provide a signed and dated informed consent
• Capable of comprehending and consenting in English
• Willing and able to comply with all study procedures, study visits, and be available for the duration of the study
• On a stable dose (no new, discontinued or changes in) of all prescribed pain medications and willing/able to maintain or only decrease the dose of all prescribed pain medications
• Tried appropriate conventional medical management for their pain
• Not indicated for additional surgical treatment in the opinion of the referring physician or spinal surgeon
• Undergone previous spinal surgery
• Diagnosed with FBSS with appropriate pain score
• Primary pain at appropriate spinal level

Exclusion criteria

• Has an active implanted device, whether turned on or off
• Displays current signs of a systemic infection
• Pregnant or lactating, inadequate birth control, or the possibility of pregnancy during the study
• Has untreated major psychiatric comorbidity
• Has serious drug-related behavioral issues
• Has neurological abnormalities unrelated to Failed Back Surgery Syndrome
• Diagnosed with Raynaud disease
• Diagnosed with Fibromyalgia
• Has any active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to screening
• 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
• Has characteristics/limits of household or close contacts involved in study (eg, family member already a study participant where blind could be broken)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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53 participants in 4 patient groups

Sham

Sham Comparator group

Description:

Frequency Setting - Sham

Treatment:

Device: Sham

1200 Hz

Experimental group

Description:

Frequency Setting - 1200 Hz

Treatment:

Device: 1200 Hz

3030 Hz

Experimental group

Description:

Frequency Setting - 3030 Hz

Treatment:

Device: 3030 Hz

5882 Hz

Experimental group

Description:

Frequency Setting - 5882 Hz

Treatment:

Device: 5882 Hz