HOPE Trial
ECAP-Controlled, Closed Loop Stimulation of the Conus Medullaris for the Treatment of Chronic Pelvic Pain & Pudendal Neuralgia
AT LONG LAST…the Ainsworth Institute will initiating a study designed by Dr. Hunter called the “HOPE Trial.” This study will be performed with the aid of a grant from Saluda Medical. The purpose of this study is to evaluate the long term efficacy of Closed Loop Stimulation for the treatment of Chronic Pelvic Pain and Pudenda Neuralgia.
When DRG Stimulation became commercial available in the U.S. in 2016, Dr. Hunter was the first to successfully use this amazing new therapy for pelvic pain by discovering the specific neural targets that transmit and filter pain for the pudendal nerve and the vast majority of the pelvic region. When Closed Loop (CL) Stimulation became commercial available in 2022, Dr. Hunter was once again the first to successfully figure out how to utilize it for pelvic pain by targeting a specific structure within the central nervous system that was previously unusable with prior stimulation platforms.
Pelvic Pain
Pelvic Pain is one of the most disabling pain syndrome known to man and is also one of the most difficult to treat. Most patients will not find a board-certified pain management doctor for several years after the onset of pain, losing precious time that could have been used to potentially reverse the symptoms.
Pudendal Neuralgia
Pudendal neuralgia is an excruciating pain syndrome caused by damage to the pudendal nerve. This can cause difficulty sitting, pain with urination, pain with sexual contact, and even pain with wearing clothing. Treatments for pudendal neuralgia are aimed at trying to calm down the nerve irritation or, in more severe cases, interrupt the pain signals before they reach the brain.
As anyone with pelvic pain or pudendal neuralgia will tell you, it is amongst THE most painful conditions known to man and there are really no effective treatments for it. Seeing an opportunity to make more money through the desperation of these patients, hordes of physicians with no training in pain management whatsoever, let alone pelvic pain, advertise themselves as “Pelvic Experts” in an effort to convince these patients to make appointments. In the end, these patients are left to suffer in pain even longer, utilizing pointless treatments with no evidence for months on end and administered by those with no qualifications in this sub-specialty. Treatments like “hydrodissection,” suppositories with ketamine/baclofen/valium or charging cash to administer regenerative medicines that were designed for joint injuries into the pelvic region are shams that only serve to make the clinicians money. The HOPE Trial aspires to change all of that…once and for all.
The HOPE trial is a pilot study that will investigator the efficacy of ECAP controlled, Closed Loop Spinal Cord Stimulation for the treatment of chronic pelvic pain and to prove unequivocally, in a neutral and unbiased format, that this technique should become the standard-of-care for this condition.
This clinical trial is a prospective study examining the efficacy of Closed Loop Stimulation for pelvic pain and pudendal neuralgia. As Closed Loop stimulation is already commercially available, the cost of the treatment is funded through one’s insurance – this means that anyone participating in the study would be required to have medical insurance. As such, consultation and treatment associated visits would be subject to insurance policy of the individual which includes deductibles, co-insurances and copays.
Schedule a Virtual Visit to Discuss Live & See if You are a Candidate
THIS STUDY IS IRB APPROVED & ACTIVELY RECRUITING AS OF 3/8/2024
Details of the Study
Patients who qualify for the study will undergo a trial procedure with Closed Loop Stimulation – only patients reporting a minimum of 50% or more reduction in pain will move onto the implant phase of the study. Patients will be followed for 12 months after the implant and will be required to follow up at 3, 6 and 12 months after implantation.
Study Enrollment Form
Official Protocol Name: HOPE Trial – Dorsal Root Ganglion (DRG) Stimulation for the Treatment of Chronic Pelvic Pain
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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