Ignite Creation Date:
2024-05-06 @ 9:06 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02905396
Status:
TERMINATED
Last Update Posted:
2019-03-25
First Post:
2016-08-23
Brief Title:
Spinal Cord Stimulation in Small Fibre Neuropathy
Sponsor:
Academisch Ziekenhuis Maastricht
Organization:
Academisch Ziekenhuis Maastricht
Study Overview
Official Title:
Spinal Cord Stimulation in Small Fibre Neuropathy A Pilot Study
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Only 1 inclusion in 25 years
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SFN-SCS
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 andor 30 pain reduction on a mean NRS during night-time andor at least much improved or very much improved on the Patient Global Impression of Change PGIC for pain and sleep
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 andor 30 pain reduction on a mean NRS during night-time andor at least much improved or very much improved on the Patient Global Impression of Change PGIC for pain and sleep
Detailed 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 andor 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 53100000
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 35000 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 25 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 andor 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
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 35000 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 25 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL538310615 METC152054 | REGISTRY | Medical Ethical Committee Maastricht the Netherlands | None |