Spinal Cord Stimulation and Pain Relief in Painful Diabetic Peripheral Neuropathy

A Prospective Two-Center Randomized Controlled Trial

Rachel Slangen; Nicolaas C. Schaper; Catharina G. Faber; Elbert A. Joosten; Carmen D. Dirksen; Robert T. van Dongen; Alfons G. Kessels; Maarten van Kleef

Disclosures

Diabetes Care. 2014;37(11):3016-3024. 

In This Article

Abstract and Introduction

Abstract

Objective Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus. Unfortunately, pharmacological treatment is often partially effective or accompanied by unacceptable side effects, and new treatments are urgently needed. Small observational studies suggested that spinal cord stimulation (SCS) may have positive effects.

Research Design and Methods We performed a multicenter randomized clinical trial in 36 PDPN patients with severe lower limb pain not responding to conventional therapy. Twenty-two patients were randomly assigned to SCS in combination with the best medical treatment (BMT) (SCS group) and 14 to BMT only (BMT group). The SCS system was implanted only if trial stimulation was successful. Treatment success was defined as ≥50% pain relief during daytime or nighttime or "(very) much improved" for pain and sleep on the patient global impression of change (PGIC) scale at 6 months.

Results Trial stimulation was successful in 77% of the SCS patients. Treatment success was observed in 59% of the SCS and in 7% of the BMT patients (P < 0.01). Pain relief during daytime and during nighttime was reported by 41 and 36% in the SCS group and 0 and 7% in the BMT group, respectively (P < 0.05). Pain and sleep were "(very) much improved" in 55 and 36% in the SCS group, whereas no changes were seen in the BMT group, respectively (P < 0.001 and P < 0.05). One SCS patient died because of a subdural hematoma.

Conclusions Treatment success was shown in 59% of patients with PDPN who were treated with SCS over a 6-month period, although this treatment is not without risks.

Introduction

Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus (DM), and prevalence of PDPN ranges from 10 to 26%.[1–3] In many patients, the pain is of such intensity that it has a major impact on patients' health-related quality of life (HRQoL) and functional ability, including interference with general activity, mood, mobility, work, social relations, sleep, and enjoyment of life.[4]

Currently, PDPN can only be treated symptomatically; a variety of medications, alone and in combination, is often only partially effective or is accompanied by unacceptable side effects.[5–7] Given the limited effectiveness of pharmacological treatment, alternative treatment strategies have been sought to alleviate pain, including spinal cord stimulation (SCS). In SCS, an electrode is positioned posterior in the epidural space to the dorsal column at the level of the nerve roots that transmit the nociceptive information from the painful area. The epidural lead is connected to a battery producing an electrical current, which induces paraesthesia, a sensation that suppresses the pain according to the Gate Control theory.[8] Patients can reduce or increase the intensity of the electric current by means of a device that uses radio frequency transmission.

Several observational studies suggested that SCS may have a positive effect on pain in PDPN patients, with 23 out of 31 patients (74%) reporting a pain relieving effect of ≥50% after 1 year of treatment.[9–13] Three studies reported a sustained treatment effect (2–7 years) of SCS in PDPN patients.[9,10,14] As SCS is a relatively expensive therapy (˜ 12,000 Euros per patient) and not without risks, such as technical complications, there is a need for randomized controlled trials (RCTs) confirming its effectiveness in PDPN.

Therefore, we performed a multicenter RCT to determine whether SCS treatment in combination with best medical treatment (BMT) (SCS group) is more successful compared with BMT only (BMT group). Treatment success was defined as a ≥50% pain relief in pain intensity during daytime or nighttime, or an improvement for pain and sleep of ≥6 in the score of the patient global impression of change (PGIC) scale.

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