Amputees Getting Pain Relief Without Pills At Arizona Pain

Ongoing Clinical Trial At Arizona Pain Management Clinic For Chronic Post-Amputation Pain

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Arizona Pain

Jul 01, 2019, 14:30 ET

SCOTTSDALE, Ariz., July 1, 2019 /PRNewswire-PRWeb/ -- People with frequent and recurring pain from an amputated leg are being enrolled in a research study of a device designed to reduce amputation pain at Arizona Pain, a leading pain management clinic with locations across Phoenix.

Led by Tory McJunkin, M.D., an interventional pain management specialist and researcher at Arizona Pain, the study is part of a clinical trial being conducted at other sites across the United States, as well.

Post-amputation pain is a poorly understood, yet common, condition that causes significant disability and can be difficult to treat. Amputation pain occurs in approximately 60 to 70% of patients, often arising weeks or months after a limb has been removed due to accident, injury, or disease. (1-2) Pain following an amputation may develop as either residual limb pain, phantom limb pain, or phantom limb sensation. (3)

The study is testing the safety and effectiveness of an implanted device, Altius® High Frequency Nerve Block, that is designed to block nerve signals and reduce pain in an amputated limb. The investigational device sends a high-frequency electrical signal to targeted nerves to block the nerve transmission. It was developed by Neuros Medical Inc., in Cleveland, Ohio.

Called the QUEST study (High-FreQUEncy Nerve Block for PoST-Amputation Pain, ClinicalTrials.gov Identifier: NCT02221934), it is a randomized, controlled clinical study of up to 180 patients, at up to 25 clinical study sites in the U.S.

Study participants will undergo surgery to be implanted with the device. It includes a cuff electrode, which is coiled around the nerve, and a pulse generator, which is similar to a pacemaker. Together they deliver an electrical signal to the nerve when activated.

Once implanted, study participants can activate a 30-minute treatment session on demand, as needed for their pain. Participants will be followed for a year and seen in clinic once a month. They will also receive modest compensation for their time and travel.

Eligibility requirements for participating in the study include:

  • Having one amputated leg
  • Experiencing frequent and recurring amputation pain
  • Being 21 years of age or older

Those interested in learning if they are eligible may contact Arizona Pain research study coordinator at 480-563-6400.

An earlier pilot study involving 10 participants demonstrated that the implant device may be safe and effective for post-amputation pain. (Soin A., Syed Shah N., Fang Z-P. 2015. High-Frequency Electrical Nerve Block for Postamputation Pain: A Pilot Study. Neuromodulation 2015; 18:197-206). DCO# 18-0030 / LB-0042 Rev. A / Effective May 23, 2018 Page 4 of 11.

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For more information, press only:
PR Contact Name: Joshua Filani at Arizona Pain
Phone number: 480-219-9171
Email: joshf(at)arizonapain.com

For more information on product:
http://www.neurosmedical.com

References:
1. Subedi B, Grossberg GT. Phantom Limb Pain: Mechanisms and Treatment Approaches. Pain Research and Treatment. 2011;2011:864605. doi:10.1155/2011/864605.
2. Chronic Conditions Team. 5 Ways to Deal with Chronic Limb Pain After Amputation. Accessed June 28, 2016.
3. 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.

SOURCE Arizona Pain