Pain Clinical Trial
Official title:
Spinal Cord Stimulation (SCS) Versus Nerve Blocks and Physical Therapy for Complex Regional Pain Syndrome
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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