Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414804
Status:
WITHDRAWN
Last Update Posted:
2012-02-15
First Post:
2006-12-20
Brief Title:
Spinal Cord Stimulation Versus Nerve Blocks and Physical Therapy
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Spinal Cord Stimulation SCS Versus Nerve Blocks and Physical Therapy for Complex Regional Pain Syndrome
Status:
WITHDRAWN
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator decided to withdraw participation in the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to compare the efficacy of SCS using the Precision implantable neurostimulation device and conventional medical treatment nerve blocks physical therapy in subjects with recently-diagnosed Complex Regional Pain Syndrome CRPS after some more conservative treatments have failed There are significant numbers of patients with CRPS in whom conventional treatment is ineffective and SCS is used only as a last resort If SCS is effective earlier in the treatment continuum it would provide a much needed treatment alternative and increase awareness of the utility of SCS for this indication It is also possible that early intervention with SCS may limit disease progression
Detailed Description:
Standard medical treatment for moderatesevere chronic pain of Complex Regional Pain Syndrome CRPS is usually inadequate Sympathetic nerve blocks with local anesthetics are commonly employed and in some cases can be an effective option Nerve blocks are not consistently effective however and their utility is further compromised by a short duration of relief
CRPS is among the pain etiologies that can be managed via Spinal Cord Stimulation SCS this option can be quite effective at providing long-term pain relief for the management of CRPS Importantly SCS is not usually attempted until other treatment options including nerve blocks and ablative procedures have failed to produce adequate pain relief No studies have been performed to date comparing SCS to a series of nerve block injections plus physical therapy In this context it may be prudent to consider SCS earlier in the treatment continuum Instead of obliging a CRPS patient to cycle through numerous rounds of injections optimal clinical pain management may be attained through early implantation of an SCS system This prospective clinical study will compare the relative efficacy of SCS with that of repeated nerve blocks and physical therapy in a group of subjects with moderate-to-severe CRPS pain
Patients who have never had invasive treatments for CRPS pain will be randomized to either a series of sympathetic blocks plus physical therapy or SCS Changes in pain disability and quality of life outcomes will be assessed at follow up visits as well as incidence and outcomes of subjects electing to cross over to the alternate treatment option This study will generate insight into the best pain management strategies for CRPS
CRPS is among the pain etiologies that can be managed via Spinal Cord Stimulation SCS this option can be quite effective at providing long-term pain relief for the management of CRPS Importantly SCS is not usually attempted until other treatment options including nerve blocks and ablative procedures have failed to produce adequate pain relief No studies have been performed to date comparing SCS to a series of nerve block injections plus physical therapy In this context it may be prudent to consider SCS earlier in the treatment continuum Instead of obliging a CRPS patient to cycle through numerous rounds of injections optimal clinical pain management may be attained through early implantation of an SCS system This prospective clinical study will compare the relative efficacy of SCS with that of repeated nerve blocks and physical therapy in a group of subjects with moderate-to-severe CRPS pain
Patients who have never had invasive treatments for CRPS pain will be randomized to either a series of sympathetic blocks plus physical therapy or SCS Changes in pain disability and quality of life outcomes will be assessed at follow up visits as well as incidence and outcomes of subjects electing to cross over to the alternate treatment option This study will generate insight into the best pain management strategies for CRPS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None