Post Amputation Pain Study
POST-AMPUTATION PAIN STUDY
High Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
The Ainsworth Institute of Pain Management has been selected for a new Clinical Trial on post-amputation pain. The study will investigate the use of a high frequency electrical signal to block nerves transmitting pain. We are the only participating site in the Tri-State area.
In the United States, there are approximately 1.6 million individuals living with a limb amputation; by year 2050, that number is projected to reach 3.6 million. An estimated 95% of these individuals will experience at least one type of post amputation pain (PAP): residual limb pain (RLP), phantom limb pain (PLP) or phantom limb sensation (PLS). While treatments for PAP have advanced a great deal from the 1950’s methods of simply striking the painful, residual limb with a wooden mallet, we have yet to discover a consistently effective algorithm for managing these patients.
Traditionally, the treatments for Post-Amputation Pain of are extremely limited:
This study is a prospective, multicenter clinical trial studying the effects of a high frequency nerve block using peripheral nerve stimulation to treat post-amputation pain.
The study is being sponsored by Neuros using their patented Altius System™ to emit high frequency electrical stimulation to effectively block all signals coming from a painful limb.
 Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008;89(3):422-429.
 Ephraim PL, Wegener ST, MacKenzie EJ, Dillingham TR, Pezzin LE. Phantom pain, residual limb pain, and back pain in amputees: results of a national survey. Arch Phys Med Rehabil. 2005;86(10):1910-1919.
Spinal Cord Stimulation (SCS)
SCS is an innovative procedure that has yielded results for patients with pain in their back or limbs who have not found relief from any other treatments. In SCS, an electrical pulse is delivered directly to the spine, blocking certain neuron fibers’ access to the brain and consequently the brain’s ability to sense the previously perceived pain. Patients who qualify for this procedure report up to a 70% reduction in pain.
Intravenous (IV) Infusion Therapy
IV Infusion is a easy and painless therapy that might be an option for you if you suffer from chronic pain that has not responded to medication or traditional treatment. It has been shown to be effective at treating fibromyalgia, small fiber neuropathy, Complex Regional Pain Syndrome (CRPS) and Reflex Sympathetic Dystrophy (RSD). In it, medications are mixed with saline in an IV bag and slowly infused into your system.
Can I Participate in this Study?
Details of the Study
Patients who qualify for the study will receive the Neuros Altius System and then be randomized to receive either a control treatment (low frequency stimulation) or the test treatment (nerve stimulation at 50 KHz). Patients will be followed for up to one year to assess pain relief, improvements in activities of daily living and overall safety of the device. Patients will be allowed to crossover at 3 months.
Study Enrollment Form
Official Protocol Name: High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
Get Answers to Your Questions at the Ainsworth Institute
The key to finding the proper treatment for any type of pain is getting a proper diagnosis. Not all types of pain respond to the same treatments and the window for improvement can be limited. The experts at Ainsworth Institute offer the most advanced pain management treatments available today, including advanced clinical trials that aren’t yet available to the general public. Call us today for an appointment so we can get you started on your road to recovery.
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