Background
Methods
Objectives
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To demonstrate differences between tonic and burst stimulation in responder rate
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To demonstrate significant differences in the presence of paresthesia during tonic stimulation and burst stimulation
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To demonstrate that pain relief using burst stimulation is superior to pain relief using tonic stimulation
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To demonstrate differences between tonic and burst stimulation adverse events
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To demonstrate differences between tonic and burst stimulation for quality of life
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To demonstrate differences between tonic and burst stimulation for worst pain
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To demonstrate differences between tonic and burst stimulation for function
Trial design
Participants
Inclusion criteria |
• Ability to provide informed consent • Aged 22 years or older • Chronic intractable neuropathic pain of the trunk and/or limbs • Baseline average daily overall pain score of ≥60 on the Visual Analog Scale collected with the 7-day Pain Diary • Failed ≥3 documented medically supervised treatments (including, but not limited to, physical therapy, acupuncture, etc.) as well as treatment with ≥2 classes of medication • Stable pain-related medication regimen 4 weeks prior to the screening evaluation • Deemed a good candidate for SCS by the investigator • Deemed a suitable study candidate by a psychologist or psychiatrist • Agrees not to add to or increase pain medication during the study • Willing to cooperate with the study requirements, including compliance with the regimen and completion of all office visits • Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception for the duration of the study |
Exclusion criteria |
• Current participation in a clinical trial with an active treatment arm • History of a neurostimulation trial or implanted system • Presence of an infusion pump or any implantable neurostimulator • Overall Beck Depression Inventory II score is >24 or, at the screening visit, a score of 3 on Question 9 relating to suicidal thoughts or wishes • Receiving, applying for, or considering workers’ compensation or involved in disability litigation • Concurrent clinically significant or disabling chronic pain problem that requires additional treatment • Existing medical condition that is likely to require repetitive MRI evaluation • Existing medical condition that is likely to require the use of diathermy • History of cancer requiring active treatment in the past 6 months • Pain originating from peripheral vascular disease • Participant is immunocompromised • Documented history of allergic response to titanium or silicone • Documented history of substance (narcotics, alcohol, etc.) abuse or dependency in the 6 months prior to baseline • Pregnancy (confirmed by positive urine/blood test) |
Interventions
Assessment tools
Visit | Assessments |
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Enrollment and screening | • Pain history and demographics • BDI-II • Pain Location Form • Medications • Provide subject with the 7-day Pain Diary for the baseline evaluation |
Baseline evaluation | • 7-day Pain Diary returned • SF-MPQ-2 • ODI2.1a • SF-36v2TM • PCS • Medications |
Trial system implantation | • 7-day Pain Diary returned • Medications |
End of trial visit (4–8 days after trial system implantation) | • Medications • End-of-trial physician assessment |
System implantation | • Medications • Physician’s record surgical summary for the procedure, including any complications |
Randomization/activation | • Medications • Participant programming record |
Control phase follow-up visits (Occurring at 6, 12, 18, and 24 weeks after randomization) | • 7-day Pain Diary returned • SF-MPQ-2 • ODI2.1a • SF-36v2TM • PCS • Medications • Paresthesia mapping • Self-evaluation |
End of control phase (Assessments occurring at the 24-week visit, in addition to those described above) | • PGIC • Patient preference |
Open-label phase follow-up visits (Occurring every 6 months for up to 2 years) | • 7-day Pain Diary returned • SF-MPQ-2 • ODI2.1a • SF-36v2TM • PCS • Medications • Paresthesia mapping • Self-evaluation |
Pain history and participant demographics
Pain
Medication
Quality of life
Pain catastrophizing
Disability
Mood
Pain and paresthesia mapping
Patient Global Impression of Change
Therapy preference and satisfaction
Adverse events
Study visits
Statistical methods and data management
Sample size
Carryover estimations
Primary analysis
Additional analyses
Safety
Discussion
Trial status
Acknowledgement
Funding
Availability of data and material
Authors’ contributions
Authors’ information
Competing interests
Consent for publication
Ethics approval and consent to participate
Site name (and location) | Institutional Review Board providing review and approval of the protocol prior to participant enrollment |
Albany Medical Center (New York, NY, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |
Bronson Methodist Hospital (Kalamazoo, MI, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |
Center for Pain Relief (Charleston, WV, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |
Clinical Trials of South Carolina (Charleston, SC, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |
Comprehensive Pain & Rehabilitation (Pascagoula, MS, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |
Goodman Campbell Brain & Spine (Indianapolis, IN, USA) | St. Vincent Institutional Review Board 8402 Harcourt Road, Suite 120 Indianapolis, IN 46260 |
Houston Pain Centers (Houston, TX, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |
Integrated Pain Management Medical Group, Inc. (Walnut Creek, CA, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |
Jackson Pain Center (Jackson, MS, USA) | Baptist Health Systems 1225 North State Street Jackson, MS 39202 |
Napa Biomedical Services (Napa, CA, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |
Ned Camden Kneeland, MD (Kalispell, MT, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |
NeuroSpine Institute (Eugene, OR, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |
New York Spine & Wellness Center (North Syracuse, NY, USA) | St. Joseph’s Hospital Health Center Research Committee 301 Prospect Avenue Syracuse, NY 13203 |
Newport Beach Headache and Pain (Mission Viejo, CA, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |
Oklahoma Pain Physicians (Oklahoma City, OK, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |
St. Luke’s Hospital & Health Network (Bethlehem, PA, USA) | St. Luke’s Hospital & Health Network Institutional Review Board 801 Ostrum Street Bethlehem, PA 18015 |
The Neuroscience Center (Ocean Springs, MS, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |
Tim Houden, MD (Ogden, UT, USA) | Western Institutional Review Board 1019 39th Avenue SE, Suite 120 Puyallup, WA 98374-2115 |