The purpose of this post-market study is to evaluate changes in pain and neurological function with high frequency, 10 kHz spinal cord stimulation (SCS) therapy in patients with chronic, intractable lower limb pain associated with diabetic peripheral neuropathy, a condition known as painful diabetic neuropathy (PDN). This is a multi-center, prospective, randomized controlled study to evaluate improvement in pain and neurological function in PDN patients, with neurological function assessed via objective measures. Patients will be randomized to conventional medical management (CMM) or 10 kHz SCS plus CMM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
143
Spinal cord stimulation programmed to a frequency of 10 kHz
Conventional medical management alone
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Touchstone Interventional Pain Center
Medford, Oregon, United States
Lower limb pain responder rate
The lower limb pain responder rate is the proportion of subjects who are pain responders, where a responder is defined as having at least 50% reduction in average lower limb pain score from baseline as measured on a 10-cm Visual Analog Scale (VAS, where a higher score indicates greater pain.
Time frame: 6 months
Neurological improvement responder rate
The neurological improvement responder rate is the proportion of subjects who are neurological improvement responders, where a responder is defined as having a decrease of at least 3 points, excluding changes in foot pain under symptom scores, as assessed via the modified Toronto Clinical Neuropathy Score (mTCNS). The mTCNS assesses the severity of symptoms and sensory function loss associated with diabetic neuropathy. All symptom and sensory test scores are summed to provide a total mTCNS score for each assessment. The mTCNS has a maximum score of 33, where a higher score indicates greater neuropathy severity.
Time frame: 6 months
Lower limb pain responder rate at 3 months
The lower limb pain responder rate is the proportion of subjects who are pain responders, where a responder is defined as having at least 50% reduction in average lower limb pain score from baseline as measured on a 10-cm Visual Analog Scale (VAS), where a higher score indicates greater pain.
Time frame: 3 months
Percent change in lower limb pain intensity
Percent change in average lower limb pain intensity from baseline as measured on a 10-cm Visual Analog Scale (VAS), where a higher score indicates greater pain.
Time frame: 6 months
Percent change in PSQ-3
Percent change in Pain and Sleep Questionnaire Three-Item Index (PSQ-3) score from baseline. PSQ-3 is a three-item questionnaire to assess the impact of chronic pain on sleep. Each question is answered on a 10-cm Visual Analog Scale (VAS), and the final score is the average of the three responses. A higher score indicates greater impact of chronic pain on sleep.
Time frame: 6 months
Average change in EQ-5D-5L index
Average change in EuroQol 5-dimension 5-level (EQ-5D-5L) index score from baseline. EQ-5D-5L measures the subject's health state as assessed in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with 5 levels. The scores on these five dimensions can be presented as a health profile or can be converted to a single number summary called the "index value." A higher index score indicates higher quality of life.
Time frame: 6 months
Average change in NeuroQol
Average change in Neuropathy-Specific Quality of Life Questionnaire (NeuroQol) score from baseline. The NeuroQol measures a patient's perception of the impact diabetic peripheral neuropathy and foot ulcers on quality of life. Each question uses a 5-point Likert scale from 1 ("never") to 5 ("all the time") for frequency of symptoms. A higher NeuroQol value indicates greater impact of diabetic neuropathy on quality of life.
Time frame: 6 months
Average change in IENF density at the lower calf
Average change in intraepidermal nerve fiber (IENF) density at the lower calf from baseline. IENF is a measure of small nerve fiber density in the skin, with a higher value indicating greater density of nerve fibers.
Time frame: 6 months
Average change in mTCNS
Average change in the modified Toronto Clinical Neuropathy Score (mTCNS) from baseline. The mTCNS assesses the severity of symptoms and sensory function loss associated with diabetic neuropathy. All symptom and sensory test scores are summed to provide a total mTCNS score for each assessment. The mTCNS has a maximum score of 33, where a higher score indicates greater severity of neuropathy.
Time frame: 6 months
Average change in HbA1c
Average change in hemoglobin A1c (HbA1c) from baseline for patients with type 2 diabetes and HbA1c \>= 8.0% at enrollment
Time frame: 6 months
Average change in body weight
Average change in body weight from baseline for patients with type 2 diabetes
Time frame: 6 months
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