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CRPS Treatment Evaluation 1 Study

CREATE-1 Study CRPS Clinical TrialThe 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]

Click Here to Read More About CRPS & RSD

Traditionally, the treatments for CRPS include:

Physical Therapy
Desensitization Therapy
Oral Medications

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.


[1] Benzon, Honorio. Essentials of Pain Medicine. Philadelphia: Saunders Elsevier, 2011. Print

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Can I Participate in this Study?

Must be 18 years of age or older
A confirmed diagnosis of CRPS-I according to the new criteria from the IASP (Budapest clinical diagnostic criteria)
Has CRPS is one upper or one lower extremity
Has been diagnosed with CRPS between 1 and 6 months from the time of screening
Has a history of a traumatic event inciting CRPS (i.e. fracture, crushing injury, orthopedic surgery)
If female and of childbearing potential, is nonlactating and nonpregnant

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.

This Study is Registered at ClinicalTrials.gov


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

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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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