Spinal Cord Stimulation Versus Nerve Blocks and Physical Therapy
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|ClinicalTrials.gov Identifier: NCT00414804|
Recruitment Status : Withdrawn (Investigator decided to withdraw participation in the study)
First Posted : December 22, 2006
Last Update Posted : February 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Complex Regional Pain Syndrome Chronic Pain Pain||Device: Precision SCS Procedure: Nerve Blocks and PT||Not Applicable|
Standard medical treatment for moderate/severe 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Spinal Cord Stimulation (SCS) Versus Nerve Blocks and Physical Therapy for Complex Regional Pain Syndrome|
|Study Start Date :||December 2006|
Active Comparator: Spinal Cord Stimulation (SCS) Group
Spinal Cord Stimulation (SCS) Treatment Group
Device: Precision SCS
Precision Spinal Cord Stimulation (SCS) Therapy
|Active Comparator: Nerve Blocks and PT||
Procedure: Nerve Blocks and PT
Pain therapy utilizing Nerve Blocks with Physical Therapy
- The primary endpoint is reduction in baseline levels of pain; [ Time Frame: 12-weeks post SCS treatment compared to Nerve Blocks+PT ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414804
|Principal Investigator:||Thomas Simopoulos, MD||Beth Israel Deaconess Medical Center|