RecruitingNot ApplicableNCT03852381

Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation

Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation in Patients With Persistent Neuropathic Pain: the MOPPStim Study

Sponsor

University Health Network, Toronto

Enrollment

90 participants

Start Date

May 16, 2019

Study Type

INTERVENTIONAL

Conditions

Chronic Pain Neuropathic Pain

Summary

Spinal cord stimulation (SCS) relies on stimulation of pain-relieving pathways in the spinal cord to treat chronic neuropathic pain. Traditional paresthesia-based SCS (PB-SCS) relies on providing analgesia through stimulation of spinal cord dorsal columns but it is often associated with attenuation of analgesic benefit and lack of acceptance of paresthesias. Recently introduced three different paresthesia-free (PF-SCS) modes of stimulation aim to overcome limitations of PB-SCS. Several questions regarding PB and PF SCS modes remain unanswered including the mechanisms of therapeutic benefit, criteria for selecting patients likely to benefit, and long-term outcomes. A concerted effort is required to understand and optimize utilization of SCS. This project has the twin goals of using neuroimaging techniques to understand mechanisms that underlies analgesic benefit from PB/PF-SCS modes and to identify criteria for selecting patients based on monitoring of pain and its related domains in patients undergoing SCS trials. Achieving these objectives will increase probability of analgesic benefit while minimizing adverse effects and knowledge gains from this study will be applicable to other therapies for chronic pain conditions.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

Adults, 18 - 80 years of age, with refractory neuropathic pain (as per clinical features and DN4 score > 3/10) in back and or lower limbs for more than 3 months following lumbar spine surgery
Severity of pain > 3/10 on NRS and ODI score for disability >40/100; and
Pain refractory to conventional medical management tried for at least 3 months.

Exclusion Criteria10

Age < 18 or age ≥ 80 years;
Previous trial or implantation of SCS system;
Procedural contraindications to SCS including extensive thoracolumbar spine surgery, moderate-to-severe central canal stenosis, coagulopathy, local or systemic infection;
Pregnancy;
Opioid dose > 200 mg OMED;
Psychiatric or psychological disorder likely to impact perception of pain;
Inability to comply with the study interventions or evaluate treatment outcomes;
Mechanical spine instability as per flexion/extension lumbar X-rays;
Ongoing litigation issues related to the pain; and
Concomitant peripheral neuropathy or myopathy or central neuropathic pain (e.g. post-stroke pain).

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Interventions

DEVICESpinal Cord Stimulation

Paresthesia-based SCS(PB-SCS), with stimulating frequencies between 30 to 80 Hz that confer a tingling sensation. Three different paresthesia-free SCS (PF-SCS) modes that use frequencies in the range of 400-10,000 Hz include Burst, High Frequency stimulation at 1.2 kHz and High Density stimulation at 400 Hz.