Pain Clinical Trial
Official title:
Spinal Cord Stimulation (SCS) Versus Nerve Blocks and Physical Therapy for Complex Regional Pain Syndrome
NCT number | NCT00414804 |
Other study ID # | SCS0805 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | December 20, 2006 |
Last updated | February 13, 2012 |
Start date | December 2006 |
Verified date | February 2012 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Be diagnosed with chronic CRPS with intractable neuropathic pain of moderate to severe intensity within the last 3-6 months. - Have failed initial treatment for CRPS, such as physical therapy alone, oral medications, and/or steroids. - Be 18 years of age or older. - Be an appropriate candidate for the surgical procedures required for SCS. - Be willing and able to comply with all study related procedures and visits. - Be capable of reading and understanding patient information materials and giving written informed consent. Exclusion Criteria: - Have had any unsuccessful back or spine surgery that currently causes pain. - Have had any treatment for CRPS other than physical therapy, oral medications, or steroids. - Have any evidence of neurologic instability. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint is reduction in baseline levels of pain; | 12-weeks post SCS treatment compared to Nerve Blocks+PT | No |
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