Spinal Cord Stimulation and Pain Relief in Painful Diabetic Peripheral Neuropathy: A Prospective Two-Center Randomized Controlled Trial

Abstract

OBJECTIVEPainful 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 METHODSWe 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. RESULTSTrial 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. CONCLUSIONSTreatment 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.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).

Sustained Treatment Effect of Spinal Cord Stimulation in Painful Diabetic Peripheral Neuropathy: 24-Month Follow-up of a Prospective Two-Center Randomized Controlled Trial

“…Besides the fact that these two RCTs demonstrate a pain-relieving effect for a period of 6 months after the start of SCS treatment, only small observational studies suggest a long-term sustained effect in PDPN (3)(4)(5). In this article, we present the 24-month followup data of our recently published RCT in Diabetes Care (1).…”

“…Spinal cord stimulation (SCS) has been demonstrated to serve as a successful second-line treatment modality for painful diabetic peripheral neuropathy (PDPN), as documented in two randomized clinical trials (RCTs) (1,2). Besides the fact that these two RCTs demonstrate a pain-relieving effect for a period of 6 months after the start of SCS treatment, only small observational studies suggest a long-term sustained effect in PDPN (3)(4)(5).…”

“…Treatment success of SCS was predefined in the protocol as $50% relief of pain intensity on a numeric rating scale (NRS) for 4 days during the daytime or nighttime or "(very) much improved" for pain and sleep on the patient global impression of change (PGIC) scale at 24 months. Additional outcome parameters were assessed as previously described (1 (1). Mean pain scores during day and night decreased by 3.3 points at daytime (P , 0.001) and 3.2 points at nighttime (P , 0.001) at 24-month follow-up (Fig.…”

Spinal Cord Stimulation 50 Years Later

“…[46][47][48] One RCT described SCS outcomes for CRPS with the use of a traditional percutaneous system compared with a non-SCS control (1 RCT with 2 additional articles describing 2-and 5-year follow-up data [49][50][51], and an additional RCT (ACCURATE Study ClinicalTrials.gov identifier: NCT01923285) described data comparing DRG stimulation to traditional SCS for the treatment of lower-extremity CRPS. 52 Two RCTs addressed SCS outcomes for PDN 53,54 (with 1 additional article reporting 2-year follow-up data 55 ).…”

Spinal cord stimulation for chronic non-cancer pain: a review of current evidence and practice

“…Results from a small randomised controlled trial indicate better pain relief with SCS compared with medical treatment for painful diabetic neuropathy. 20 Evidence for the other conditions is limited.…”