Diabetic Neuropathy, Pain, Peripheral Neuropathy
Conditions
Keywords
Pain, Implantable stimulation device, Neuropathy
Brief summary
The purpose of this study is to evaluate Spinal Cord Stimulation (SCS) therapy in individuals who suffer from painful diabetic peripheral neuropathy. Patients invited to participate in this study will be eligible for SCS therapy, and will have already selected therapy with the Advanced Bionics Precision system independent of possible inclusion in this study. The device, accessories, and procedures associated with device placement and the indications for use are all consistent with the current and approved product labeling.
Detailed description
The management of neuropathic pain is often difficult, and the available treatment options rarely provide complete relief. Although prevention by means of glycemic control is the first priority, up to 20% of patients will develop Diabetic Peripheral Neuropathy (DPN) and require active drug therapy. Select anti-depressants, anti-epileptics, and opioids have generally been the first-line pharmacologic treatments for neuropathic pain. Topical creams have been used to achieve local control. Nonconventional therapies have included acupuncture and magnet therapy. However, all of these treatments have limited utility because of marginal efficacy. Various forms of electric stimulation have been shown to improve the symptoms of DPN. Advances in spinal cord stimulation technology have encouraged broader use of this treatment modality in the management of chronic painful DPN.
Interventions
DEVICEPrecision Spinal Cord Stimulation
Stimulation on throughout the study once device is implanted
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have chronic neuropathic pain in at least one limb with a score of at least 3 using the Michigan Neuropathy Screening Instrument (MNSI) secondary to Type 1 or Type 2 diabetes * Have chronic neuropathic pain for at least 12 months * Be 18 years of age or older * Be refractory to pain medication including gabapentin or the use of pain medication is contraindicated or not tolerated because of side effects or other medical condition * Be an appropriate candidate for SCS therapy and have already decided to use the Precision system * Be willing and able to comply with all study related procedures and visits * Be capable of reading and understanding patient information materials and giving written informed consent
Exclusion criteria
* Are a smoker * Have any other chronic pain condition likely to confound evaluation of study endpoints * Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints such as peripheral vascular disease or neurological disorders unrelated to diabetic neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Rating at 6 Months Post Activation Compared to Baseline | 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Stimulation (SCS) Group Spinal Cord Stimulation (SCS) Treatment Group | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Hypothyroidism diagnosis | 1 |
Baseline characteristics
| Characteristic | Spinal Cord Stimulation (SCS) Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age Continuous | 59 years STANDARD_DEVIATION 0 |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Pain Rating at 6 Months Post Activation Compared to Baseline
Time frame: 6 months