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Reality: Long-Term Real-World Outcomes Study on Patients Implanted with a Neurostimulator

Patient Population: Any subject having an Abbott neurostimulation system implanted
Device: market-released Abbott neurostimulation devices
Sponsor: Abbott
Enrollment: Active

  • The REALITY study is a prospective, multi-center, open label investigation conducted to gain a broader understanding of how Abbott’s neurostimulation systems are being used in the real-world setting. It will serve the dual purpose of collecting long-term safety and effectiveness of these devices and obtaining information about the different patient populations who are using them.
  • Qualifications: This clinical investigation will enroll adult male and female individuals scheduled to have an Abbott neurostimulation system implanted. Participants must have a baseline (with no stimulation) pain NRS of > 6. Participants must be willing to undergo a surgical procedure and come in for follow-up visits.

Thermaquil: Evaluation of noninvasive thermal neuromodulation for temporary relief of or reduction in occipital pain

Patient population: Occipital Neuralgia
Sponsor: Thermaquil
Enrollment: Active

  • The purpose of this study is to evaluate the efficacy of thermal neuromodulation for the temporary relief of or reduction in pain due to occipital neuralgia. The primary objective of this study is to evaluate the efficacy of cyclically applied heat and cold to the occipital region on the relief of pain in patients experiencing occipital neuralgia.
  • Qualifications: This study will enroll adult subjects who are suffering from occipital neuralgia.

Thermaquil: Evaluation of noninvasive thermal neuromodulation for temporary relief of or reduction in pain

Patient Population: evaluate if applications of heat and cold can decrease the intensity and frequency of pain

Sponsor: Thermaquil
Enrollment: Active

  • The primary purpose of this study is to evaluate the effectiveness of noninvasive thermal neuromodulation (cyclical application of heat and cold) for the temporary relief of, or reduction in pain. Secondarily, this study will collect information related to the optimal heat/ cold cycles for relieving pain

Trialing of Intra-spinal Stimulation in patients with complex regional pain syndrome or causalgia

Patient Population: complex regional pain syndrome type I or causalgia.

Device: Medtronic SCS
Sponsor: Millennium Pain Center
Enrollment: Active

  • The Primary purpose of this study is To determine the feasibility of intra-spinal stimulation with optimal paresthesia coverage therapy for chronic pain relief in patients with complex regional pain syndrome type I or causalgia. This is a multi-center, prospective, open label, single-arm, observational, feasibility study. Up to 20 patients with intractable chronic severe limb pain associated with complex regional pain syndrome (CRPS) will be included in the study.
  • Qualificatios: This study will enroll adult subjects who suffer from complex regional pain syndrome type I or causalgia of the lower limb(s). Participants must have a baseline (with no stimulation) pain NRS of > 6. Participants must be willing to undergo a surgical procedure and come in for follow-up visits.

Sham-controlled, double-blind, randomized trial of intra-articular pulsed radiofrequency neuromodulation versus intra-articular steroids for painful knee osteoarthritis

Patient Population: Painful Knee Osteoarthritis
Device: Pulsed Radiofrequency
Sponsor: Center For Interventional Pain and Spine
Enrollment: Active

  • The purpose of this research is to compare the efficacy of intra-articular pulsed radiofrequency (PRF) by investigational ACCURIANTM Radiofrequency Generator device to intra-articular steroids and saline injection in patients with moderate-severe painful osteoarthritis of the knee. Subject will be randomized into 1 of 3 groups.
  • Qualifications: This study will enroll adult subjects who are suffering from painful osteoarthritis in one or both knees. Participants must not of had a knee injection in the past 3 months or a history of knee replacement.

SGX Procura: Post-Market Observational Clinical Study to Evaluate the Effects of DTM™SCS programming in threatening Intractable Chronic Upper Extremity Limb Pain

Patient Population: Upper Limb and Neck
Device: Medtronic SCS
Sponsor: SGX Procura
Enrollment: Active

  • The purpose of this observational clinical study is to evaluate the effectiveness and to collect safety data of DTMTM SCS programming on subjects with chronic, unilateral or bilateral upper limb pain. This is a post-market, open-label, prospective, multi-center, observational study. The study will utilize a commercially available SCS system (Medtronic IntellisTM neurostimulator)
  • Qualifications: This study will enroll adult subjects who have neck and/or upper limb pain. Participants must have a baseline (with no stimulation) pain NRS of > 5. Potential subjects cannot have undergone, within 30 days prior to enrollment, a procedure and/or surgery to treat upper limb pain, which is providing significant pain relief. Participants cannot have had any surgery on the posterior elements of the neck.

SGX Nova: Open-Label, Post Market Study: A Clinical Trial to Study the Effects of DTM Spinal Cord Stimulation (DTM™SCS) programs in treating Intractable Chronic Back Pain in Subjects without prior history of Spine Surgery

Patient Population: Back and Leg Pain without history of spine surgery
Device: Medtronic SCS
Sponsor: SGX Nova
Enrollment: Active

  • The purpose of this study is to study the effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with chronic, back and leg pain without  a prior history of spine surgery. Subjects meeting study entrance criteria will be randomized into one of two study treatment groups: Test treatment group with DTM-SCS programming approach Control treatment group with Conventional SCS programming approach
  • Qualifications: This study will enroll adult subjects who have neck and/or upper limb pain. Participants must have a baseline (with no stimulation) pain NRS of > 6. Subject must not have a history of low back surgery or qualify for spine surgery.

A Prospective, Multi-Center, Bi-Phasic Randomized Design to Compare Outcomes of the CornerLoc™ SI Joint Stabilization System and Intra-Articular Sacroiliac Joint Steroid Injection in Patients with Refractory Sacroiliac Joint Dysfunction

Patient Population: Sacroiliac Joint Dysfunction
Device: CornerLoc
Sponsor: CornerLoc
Enrollment: Active

  • The purpose of this study is to compare the safety and effectiveness of the CornerLoc™ SI Joint Stabilization System to intra-articular sacroiliac joint steroid injection in patients with sacroiliac joint dysfunction. Subjects meeting eligibility criteria will be randomized into one of two study groups. The test group will receive the CornerLoc device and the other group will receive a sacroiliac joint steroid injection.
  • Qualifications: This study will enroll adult subjects who are experiencing SI joint pain and dysfunction. Participants must have pain NRS .

Scope: A 5-year Superion IDS Clinical Outcome Post-Approval Evaluation

Patient Population: Lumbar Spinal Stenosis
Device: Superion IDS Device
Sponsor: Boston Scientific
Enrollment: Active

  • The purpose of this study is to compile real-world outcomes of the Superion® IDS in routine clinical practice, when used according to the applicable Directions for Use.
  • Qualifications: This study will enroll subjects with persistent leg/buttock/groin pain with or without back pain that is consistently relieved with flexion activities (ex: sitting/bending over a shopping cart) and be able to sit for 50 minutes without pain and walk 50 feet or more. Participants cannot have radiculopathy, osteoporosis, scolosis, or prior surgery of the lumbar spine.

Electrically evoked compound action potentials human observation Medtronic system study

Patient Population: Any patient undergoing SCS trial
Device: Medtronic SCS
Sponsor: Medtronic
Enrollment: Active

  • The purpose of this study is to collect recordings of evoked waveforms with various SCS settings with subjects in different positions and performing different activities within the clinic and/or at home.
  • Qualifications: This study will enroll subjects who are a candidate for Medtronic SCS trial for a labeled indication. Subjects may not have implanted electrical cardiac device or a buried lead trial.

Spinal Cord Stimulation in the treatment of Chronic, Intractable Pain using the Nalu Neurostimulation System

Patient Population: FBSS with low back and leg pain
Device: Nalu Neurostimulation System
Sponsor: Nalu
Enrollment: not yet active

  • The purpose of this study is to look at the comfort and efficacy of the Nalu Neuromodulation System, including programming platforms and responder rates. This will be done using a series of questionnaires and in office visit.
  • Qualifications: This study will enroll subjects who have intractable neuropathic pain of legs and back and are unresponsive to conservative treatment. Patient must have failed back surgery syndrome diagnosis. Back and leg NRS ≥ 6. Subjects must not another active implantable medical device or have had previously failed SCS therapy.

DTM-LE: Differential-Target Multiplex Low Energy Spinal Cord Stimulation Study

Patient Population: Patient with chronic intractable back and leg pain
Device: Medtronic Intellis SCS
Sponsor: Medtronic
Enrollment: Active

  • The purpose of this study is to characterize changes in overall (back and leg) pain intensity, as measure by visual analog scale (VAS) and to characterize programming parameters associated with energy use.
  • Qualifications: This study will enroll subjects who are a candidate for SCS system with back and leg NRS ≥ 6 and overall pain NRS ≥ 6. Subjects must not have previously trialed SCS, PNS, or IT drug therapy.

Distinct: Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain

Patient Population: Virgin low back pain who are not surgical candidates
Device: Proclaim XR
Sponsor: Abbott
Enrollment: Active

  • The purpose of this study is to to determine in difference in responders between groups at 6 months, responders are determined as either an improvement in function, defined as ≥ 13% decrease on ODI or score ≤ 20 %) OR Improvement in pain, defined as a ≥ 50% decrease on NRS
  • Qualifications: This study will enroll subjects who are a candidate for SCS stimulation with no previous spine surgery for back and leg pain or sacroiliac joint fusion. Subjects must have had at least 6 months of conservative care. Subject must not have severe scoliosis, regularly take systemic steroids, have IT drug pump, or have fibromyalgia.

Office Locations

Center for Interventional Pain & Spine, LLC has multiple convenient locations to serve you. Get started by requesting an appointment at any of our offices located in Delaware and Pennsylvania areas near major hospitals and highways.

  • Delaware
  • Pennsylvania
Silverside Carr Corporate Center
405 Silverside Road, Suite 104, Wilmington, DE 19809
844-365-PAIN (7246)
302-792-1372
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Brandywine Town Center
3401 Brandywine Parkway, Suite 202, Wilmington, DE 19803
844-365-PAIN (7246)
302-477-6955
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Sandhill Plaza
118 Sandhill Drive, Suite 203, Middletown, DE 19709
844-365-PAIN (7246)
302-378-0941
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The Helen F. Graham Cancer Center
4701 Ogletown-Stanton Road, Suite 1200, Newark, DE 19713
844-365-PAIN (7246)
302-792-1372
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Pike Creek Sports Medicine and Professional Center
3105 Limestone Road, Suite 300, Wilmington, DE 19808
844-365-PAIN (7246)
302-482-2212
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Halpern Medical Plaza
1197 Airport Road, Second Floor, Suite 5, Milford, DE 19963
844-365-PAIN (7246)
302-503-3432
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Surgical Center Affiliations

  • Delaware
  • Pennsylvania
Orthopaedic Specialist Surgery Center
1096 Old Churchmans Road, Newark, DE 19713
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Delaware Outpatient Center for Surgery
774 Christiana Road, Ste 2, Bldg B, Newark, DE 19713
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Wilmington Hospital
501 W. 14th Street, Wilmington, DE 19801
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Wilmington Roxana Canon Arsht Surgicenter
625 W. 12th Street, Wilmington, DE 19801
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First State Surgery Center
1000 Twin C Lane, Suite 200, Newark, DE 19713
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Delaware Surgery Center
200 Banning Street, Suite 110, Dover , DE 19904
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