Spinal Cord Stimulation in Small Fibre Neuropathy — SFN-SCS  

Small Fiber Neuropathy Clinical Trial

Official title: Spinal Cord Stimulation in Small Fibre Neuropathy: A Pilot Study

Status Terminated

Clinical Trial Summary

Small fibre neuropathy (SFN) is a disorder in which selectively thinly myelinated and unmyelinated nerve fibres are involved. SFN can cause severe and chronic symptoms such as burning pain in the extremities in combination with autonomic symptoms. So far, the results of symptomatic SFN treatment have been rather disappointing, despite the fact that new agents have been developed.

This study is a pilot study to investigate whether Spinal Cord Stimulation (SCS) combined with best (drug) treatment as usual (TAU) leads to clinically significant pain relief in patients suffering from pain in the lower limbs due to SFN, defined as ≥30% pain reduction on a mean NRS during daytime, and/or ≥30% pain reduction on a mean NRS during night-time, and/or at least much improved or very much improved, on the Patient Global Impression of Change (PGIC) for pain and sleep.

Clinical Trial Description

Small fibre neuropathy (SFN) is caused by dysfunction of the Aδ-fibres and C-fibres. SFN is diagnosed if there are typical SFN symptoms together with abnormal intraepidermal nerve fibre density (IENFD) in skin biopsy and/or abnormal temperature thresholds in quantitative sensory testing (QST). A large number of disorders can underlie SFN, such as diabetes, amyloidosis, sarcoidosis and other systemic illnesses, vasculitis, and HIV. The proportion of idiopathic or cryptogenic SFN reported in literature varies between 24% and 93%. SFN is not a rare condition; a recent study showed a minimum prevalence of 53/100.000.

SFN can cause severe and chronic symptoms such as burning pain in particularly the extremities in combination with autonomic symptoms, with a significant impact on quality of life. Moreover, neuropathic pain disorders are associated with anxiety, depression and sleep disturbances, polypharmacy and significant healthcare resource use. Therefore, neuropathic pain has a significant impact on society due to the high socioeconomic costs. The treatment of SFN still largely relies on the agents generally used for neuropathic pain relief, particularly derived from diabetic painful neuropathic studies, such as antidepressants (amitriptyline, duloxetine), anti-epileptic agents (pregabalin, gabapentin), opioids and topical agents (lidocain and capsaicin), but have been disappointing in SFN (clinical observation in > 400 patients treated). Therefore it is of major importance to develop new treatment options that can provide sufficient pain relief for the individual patient.

In 1965 Melzack and Wall introduced the gate theory of pain perception. This theory offered new perspectives in treating neuropathic pain. In the seventies SCS was introduced. It was thought that the stimulation of the large myelinated fibres modulates the transmission of pain signals, which run through small, non-myelinated fibres. The exact mechanism of SCS is still unknown. Nowadays SCS is used worldwide and the global sales are estimated for more than 35.000 systems annually. Recently, a prospective two-centre randomized controlled trial was performed to investigate the effect of SCS in painful diabetic polyneuropathy. SCS was successful in 59% of the patients, and the effect lasted for at least 2.5 years in most patients.

The current pilot study will focus on the potential effect of SCS in patients with SFN. The main study parameter will be the mean pain intensity as measured on a Numeric Rating Scale (NRS) and/or a Patient Global Impression of Change (PGIC) for pain and sleep measured on a 7-point Likert scale, after 12 months of treatment in patients with SFN and intractable neuropathic pain in the lower limbs. Besides the primary objective, the following secondary aims are investigated:

1. The effect of SCS on pain (at least 30% pain reduction, on mean daily, night, and maximum pain);

2. the effect of SCS on activity and participation;

3. the effect of SCS on and health related quality of life;

4. the effect of SCS on mood in SFN;

5. the effect of SCS on the reduction of pain medication. ;

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Small Fiber Neuropathy

• NCT number: NCT02905396
• Study type: Interventional
• Source: Academisch Ziekenhuis Maastricht
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2018
• Completion date: January 28, 2019