Clinical Trial: Spinal Cord Stimulation in Small Fibre Neuropathy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary:

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 modul
Sponsor: Academisch Ziekenhuis Maastricht

Current Primary Outcome: Pain relief [ Time Frame: Up to 1 year ]

The primary objective of this study is to investigate whether SCS combined with best (drug) treatment as usual (TAU) leads to clinically significant (≥30%) pain relief in patients suffering from pain in the lower limbs due to SFN after 12 months of treatment.

Clinical significant pain relief is determined as:

  1. ≥30% pain reduction on the mean daytime pain using the NRS, and/or
  2. ≥30% pain reduction on the night-time pain using the NRS and/or
  3. At least much improved or very much improved on the Patient Global Impression of Change (PGIC) for pain and sleep.


Original Primary Outcome: Pain relief [ Time Frame: 1 year ]

The primary objective of this study is to investigate whether SCS combined with best (drug) treatment as usual (TAU) leads to clinically significant (≥30%) pain relief in patients suffering from pain in the lower limbs due to SFN after 12 months of treatment.

Clinical significant pain relief is determined as:

  1. ≥30% pain reduction on the mean daytime pain using the NRS, and/or
  2. ≥30% pain reduction on the night-time pain using the NRS and/or
  3. At least much improved or very much improved on the Patient Global Impression of Change (PGIC) for pain and sleep.


Current Secondary Outcome:

  • Pain reduction [ Time Frame: Up to 1 year ]
    The effect of SCS on pain. Number of patient with a pain reduction of ≥50% on a mean daytime, night-time and maximum pain (separately examined) using the PI-NRS.
  • Activity and participation [ Time Frame: Up to 1 year ]
    The effect of SCS on activity and participation: questionnaire
  • Quality of life [ Time Frame: Up to 1 year ]
    The effect of SCS on health related QoL in SFN: questionnaire
  • Mood [ Time Frame: Up to 1 year ]
    The effect of SCS on mood in SFN: questionnaire
  • Reduction of pain medication [ Time Frame: Up to 1 year ]
    The effect of SCS on the reduction of pain medication: questionnaire
  • Change in SFN symptoms [ Time Frame: Up to 1 year ]
    The effect of SCS on a change in SFN symptoms will be measured by the symptom inventory questionnaire (SFN-SIQ) at baseline, 2 weeks, 3, 6, 9, and 12 months.


Original Secondary Outcome:

  • Pain reduction [ Time Frame: 1 year ]
    The effect of SCS on pain. Number of patient with a pain reduction of ≥50% on a mean daytime, night-time and maximum pain (separately examined) using the PI-NRS.
  • Activity and participation [ Time Frame: 1 year ]
    The effect of SCS on activity and participation: questionnaire
  • Quality of life [ Time Frame: 1 year ]
    The effect of SCS on health related QoL in SFN: questionnaire
  • Mood [ Time Frame: 1 year ]
    The effect of SCS on mood in SFN: questionnaire
  • Reduction of pain medication [ Time Frame: 1 year ]
    The effect of SCS on the reduction of pain medication: questionnaire
  • Change in SFN symptoms [ Time Frame: 1 year ]
    The effect of SCS on a change in SFN symptoms will be measured by the symptom inventory questionnaire (SFN-SIQ) at baseline, 2 weeks, 3, 6, 9, and 12 months.


Information By: Academisch Ziekenhuis Maastricht

Dates:
Date Received: August 23, 2016
Date Started: October 2016
Date Completion: December 2018
Last Updated: September 16, 2016
Last Verified: September 2016