SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease
- Conditions
- Painful Diabetic NeuropathyChronic Pain SyndromeLimb PainDiabetes Mellitus, Type 2Chronic PainPeripheral Arterial DiseaseSpinal Cord Stimulation
- Interventions
- Device: Spinal cord stimulationDevice: Sham stimulation
- Registration Number
- NCT06480786
- Lead Sponsor
- University of Nebraska
- Brief Summary
Peripheral arterial disease (PAD) affects over 230 million adults worldwide and is a highly morbid, costly, and disabling condition. Ischemic leg pain drives disability in PAD patients and results from oxygen supply-demand mismatch, autonomic dysfunction, and muscle breakdown. This leg pain, which is unresponsive to traditional pharmacotherapy, limits the patient's tolerance to exercise, which is an important disease-modifying intervention. Spinal cord stimulation is a well-established therapy for medically intractable pain, including painful diabetic neuropathy (PDN) and ischemic pain, but is not part of the standard-of-care for PAD despite limited promising clinical data. Early studies used first-generation, tonic stimulation devices, but with these it was impossible to perform sham-controlled trials to test the treatment. Since then, new types of waveform treatments, including high-frequency spinal cord stimulation (SCS), have been shown to be more effective in the treatment of intractable pain. While high-frequency SCS is approved for PDN treatment, it has never been tested in the treatment of claudication pain from PAD.
This study will enroll up to 15 participants between the ages of 19 and 89 who have PAD and PDN and are successfully implanted with a permanent SCS. Twelve weeks after SCS implantation, participants will receive two weeks of stimulation and two weeks of sham intervention, in random starting order. Blood flow, blood pressure, skin oxygen levels, and participant reported pain int the lower extremities will be assessed before SCS implantation, 12 weeks after SCS implantation and during each of the treatment periods. Participants will also complete a quality of life survey at the same time points. Comparisons of these measurements with the baseline and post-implantation measurements to determine the effects of SCS.
- Detailed Description
Peripheral arterial disease (PAD) affects over 230 million adults worldwide and is a highly morbid, costly, and disabling condition. Ischemic leg pain drives disability in PAD patients and results from oxygen supply-demand mismatch, autonomic dysfunction, and muscle breakdown. This leg pain, which is unresponsive to traditional pharmacotherapy, limits the patient's tolerance to exercise, which is an important disease-modifying intervention. Spinal cord stimulation is a well-established therapy for medically intractable pain, including painful diabetic neuropathy (PDN) and ischemic pain, but is not part of the standard-of-care for PAD despite limited promising clinical data. Early studies used first-generation, tonic stimulation devices, but with these it was impossible to perform sham-controlled trials to test the treatment. Since then, new types of waveform treatments, including high-frequency spinal cord stimulation (SCS), have been shown to be more effective in the treatment of intractable pain. While high-frequency SCS is approved for PDN treatment, it has never been tested in the treatment of claudication pain from PAD.
This study will enroll up to 15 participants between the ages of 19 and 89 who have PAD (ankle-brachial index under 0.90 or vascular imaging, and experience pain from walking with a pain level of at least 6 cm for at least 3 months )and PDN and who meet inclusion criteria for permanent spinal cord stimulator (SCS) placement. Participants must also have diabetes with symptoms of neuropathy, have a starting pain level of at least 5 cm on a visual pain scale and Vascular Quality of Life Questionnaire score of 5.5 or less.
The study begins with an initial evaluation visit, then a follow-up visit 12 weeks after permanent SCS implantation and optimization. Participants will then be randomized to start in the SCS group or the sham intervention group. Each of these interventions will be conducted for two weeks, then participants will switch to the other intervention in a cross over design. Blood flow, blood pressure, skin oxygen levels, and participant reported pain int the lower extremities will be assessed before SCS implantation, 12 weeks after SCS implantation and during each of the treatment periods. Participants will also complete a quality of life survey at the same time points. Comparisons of these measurements with the baseline and post-implantation measurements to determine the effects of SCS. The study intervention lasts for 4 weeks, after which participants will return to standard SCS care.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 19 years to 89 years old
- Diagnosed diabetes mellitus
- Signs or symptoms of neuropathy and maximum baseline visual-analog pain scale ≥ 5 cm and peripheral arterial disease (diagnosed by ankle-brachial index < 0.90 or vascular imaging studies) with claudication and exertion-induced visual-analog pain scale ≥ 6 cm for a minimum of 3 months
- Successful spinal cord stimulator (SCS) trial (>50% relief of chronic lower extremity pain) and will have a new permanent SCS placed prior to study intervention
- Uncontrolled psychological or psychiatric disorder
- Inability to hold antithrombotic therapy per the American Society of Regional Anesthesia guidelines
- Non-healing wounds
- Gangrene
- Critical limb ischemia
- Prior lower extremity amputation
- Inability to adhere to study follow-up
- Mechanical spine instability based on flexion/extension radiographs of the lumbar spine
- Prior or current spinal cord stimulator implant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active Spinal Cord Stimulation Spinal cord stimulation Therapeutic spinal cord stimulation titrated at 12 weeks post operative at standard clinical practice. Sham Stimulation Sham stimulation Sub-threshold low frequency spinal cord stimulation to provide no analgesic benefit but serve as a sham control.
- Primary Outcome Measures
Name Time Method High-frequency Spinal Cord Stimulation Effect on Analgesia Baseline, 12 week follow-up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2 The visual analogue scale (VAS) will be used by participants to report lower extremity pain during interventions. The VAS score is a10-cm line that represents a continuum between "no pain" and "worst pain."
- Secondary Outcome Measures
Name Time Method High-frequency Spinal Cord Stimulation Effect on Quality of Life Baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2 Quality of life changes from high-frequency high-frequency spinal cord stimulation (SCS) will be measured by the Vascular Quality of Life Questionnaire (VASCUQOL). This instrument has 25 questions covering pain, symptoms, activities, social, and emotional. Each question has seven responses from 1 (worst) to 7 (best).
High-frequency Spinal Cord Stimulation Effect on Blood Flow Baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2 Changes in blood flow from high-frequency spinal cord stimulation (SCS) will measure lower extremity capillary digit blood flow flow by laser speckle imaging.
High-frequency Spinal Cord Stimulation Effect on Autonomic Control Baseline, 12 week follow-up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2 Changes in autonomic control from high-frequency spinal cord stimulation (SCS) will measure sympathetic vasomotion by volume-clamp method on digits of the hand and laser speckle imaging on the lower extremities.
Trial Locations
- Locations (1)
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States