Comparison of tonic spinal cord stimulation, high-frequency and burst stimulation in patients with complex regional pain syndrome: a double-blind, randomised placebo controlled trial

Abstract

BackgroundComplex Regional Pain Syndrome (CRPS) is a disabling disease that is sometimes difficult to treat. Although spinal cord stimulation (SCS) can reduce pain in most patients with CRPS, some do not achieve the desired reduction in pain. Moreover, the pain reduction can diminish over time even after an initially successful period of SCS. Pain reduction can be regained by increasing the SCS frequency, but this has not been investigated in a prospective trial. This study compares pain reduction using five SCS frequencies (standard 40 Hz, 500 Hz, 1200 Hz, burst and placebo stimulation) in patients with CRPS to determine which of the modalities is most effective.DesignAll patients with a confirmed CRPS diagnosis that have unsuccessfully tried all other therapies and are eligible for SCS, can enroll in this trial (primary implantation group). CRPS patients that already receive SCS therapy, or those previously treated with SCS but with loss of therapeutic effect over time, can also participate (re-implantation group). Once all inclusion criteria are met and written informed consent obtained, patients will undergo a baseline assessment (T0). A 2-week trial with SCS is performed and, if successful, a rechargeable internal pulse generator (IPG) is implanted. For the following 3 months the patient will have standard 40 Hz stimulation therapy before a follow-up assessment (T1) is performed. Those who have completed the T1 assessment will enroll in a 10-week crossover period in which the five SCS frequencies are tested in five periods, each frequency lasting for 2 weeks. At the end of the crossover period, the patient will choose which frequency is to be used for stimulation for an additional 3 months, until the T2 assessment.DiscussionCurrently no trials are available that systematically investigate the importance of variation in frequency during SCS in patients with CRPS. Data from this trial will provide better insight as to whether SCS with a higher frequency, or with burst stimulation, results in more effective pain relief.Trial registrationCurrent Controlled Trials ISRCTN36655259

Effects of Tonic Spinal Cord Stimulation on Sensory Perception in Chronic Pain Patients: A Systematic Review

“…). Of these, 15 were articles (Table ) and 14 were abstracts/records of ongoing or unpublished studies (Supporting Information Table S3).…”

Preferred frequencies and waveforms for spinal cord stimulation in patients with complex regional pain syndrome: A multicentre, double‐blind, randomized and placebo‐controlled crossover trial

“…Reporting of the results is in accordance with the CONSORT statement (Schulz et al, 2010). The study protocol was registered in the Current Controlled Trials database (registration number ISRCTN 36655259) and was published in peer-reviewed journal that fully details the inclusion and exclusion criteria (Kriek et al, 2015b). A flowchart and an overview of all outcome parameters of the entire comprehensive study are provided in Supporting Information Fig.…”

Spinal Cord Stimulation for Acute Pain Following Surgery for Cervical Myelopathy: A Novel Treatment Strategy

“…However, despite over 50 years of clinical utilization and research, our understanding of the mechanisms by which SCS diminishes pain is limited . Nevertheless, in animal models of neuropathic pain, SCS has been shown to inhibit the hyperexcitability of dorsal horn wide dynamic range neurons and induce the release of GABA in the dorsal horns of the spinal cord gray matter, which results in subsequent amelioration of glutamatergic neurotransmission . Our understanding of how SCS impacts pain processing mechanisms does not preclude a potentially efficacious set of effects in acute, subacute, and acute‐on‐chronic pain.…”