CREATE-1 STUDY
CRPS Treatment Evaluation 1 Study
The Ainsworth Institute of Pain Management has been selected join a phase 3 clinical trial studying the efficacy and safety of the drug AXS-02 for the treatment of Complex Regional Pain Syndrome Type 1 (CRPS-I). This study is being conducted at several sites around the world.
CRPS (aka Reflex Sympathetic Dystrophy of RSD) chronic and progressive condition causing excruciating pain. CRPS, according to definition, affects the upper and lower extremities and is more likely in women than in men. The general definition is:
CRPS describes an array of painful conditions that are characterized by a continuing (spontaneous and/or evoked) regional pain that is seemingly disproportionate in time or degree to the usual course of any known trauma or other lesion. The pain is regional (not in a specific nerve territory or dermatome) and usually has a distal predominance of abnormal sensory, motor, sudomotor, vasomotor, and/or trophic findings. The syndrome shows variable progression over time.[1]
Traditionally, the treatments for CRPS include:
This study is a phase 3, randomized, double blind, placebo-controlled, multicenter trial looking at the drug AXS-02 administered orally to patients with CRPS-I.
References
[1] Benzon, Honorio. Essentials of Pain Medicine. Philadelphia: Saunders Elsevier, 2011. Print
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.
Intrathecal Pump (Pain Pump)
An Intrathecal Pump is a targeted drug delivery system that delivers amazingly small amounts of medication directly to the central nervous system. Several medications can be used simultaneously within these pumps to create profound pain relief while limiting the side effects that are commonly reported with oral medications. The primary benefit of a pump around-the-clock pain relief, even while you’re sleeping.
Can I Participate in this Study?
Details of the Study
Patients who qualify for the study will be randomized to receive either 50mg of AXS-02 per week or placebo for 6 weeks and then be expected to follow up for roughly 5 months to compare the efficacy of the treatments. Patients will be expected to keep a pain diary and take calcium & Vitamin D supplements.
Study Enrollment Form
Official Protocol Name: CREATE-1 Study: CRPS Treatment Evaluation 2 Study A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-02 (Disodium Zoledronate Tetrahydrate) Administered Orally to Subjects with Complex Regional Pain Syndrome Type I
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.
