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scrambler therapy clinical trial

CLINICAL TRIAL: Arachnoiditis Nerve Pain Relief

April 12, 2019

2019 CLINICAL TRIAL – DIAGNOSED ARACHNOIDITIS PATIENTS

Study

Calmare Therapy NJ USA (Scrambler Therapy) to Treat Diagnosed Cases of Arachnoiditis to Reduce Chronic Neuropathic Pain Symptoms

Phase

Pilot

What is Arachnoiditis?

Arachnoiditis is a chronic pain disorder caused by the inflammation of the arachnoid membrane and subarachnoid space that surround the nerves of the spinal cord. The inflammation can cause the meninges to adhere to the spinal cord and nerve roots.

Because the nerve roots are affected, symptoms such as numbness, tingling, and burning pain are often felt in the lower back or legs.

Severe cases of arachnoiditis can result in the loss of motor function, loss of bladder and bowel control and even paralysis.

Arachnoiditis can arise from infection, direct spinal injury, and chronic compression of the spinal nerves or invasive spinal surgeries.

Study Conducted by

Dr. Michael J. Cooney
Calmare Therapy NJ USA

Location

Rutherford, NJ (10 miles from New York City)

Study Start Date

May 13 – 24, 2019

Details

Calmare Therapy NJ USA is one of only seven Calmare Certified providers of scrambler therapy, an FDA-cleared, non-invasive, pain-free, drug-free technology to treat patients suffering from several types of long-term, high-intensity pain.

Scope of May 2019 Calmare Study

We are conducting a free, 10-treatment (one 35-minute daily therapy session) clinical trial study for pre-qualified patients suffering from diagnosed Arachnoiditis to determine the efficacy of scrambler therapy as a viable treatment solution for condition-induced neuropathy.

Eligibility Criteria

Pre-approved study patients must be available to undergo a protocol of 10 treatments once per day. There is no charge for the series of 10 treatments.

Travel, daily transportation, meals and accommodations are not covered for this trial

Informed Consent

People who agree to take part in the study are asked to sign an Informed Consent Form. However, signing the form does not mean approved trial participants must stay in the study for the duration. Volunteer participants can leave the study at any time—either before the study starts or at any time during the study or the follow-up period.

The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, clinical trial researchers will; inform the participants.

To Apply  |  Contact Us  |  For More Information

To find out more and determine if you qualify for the no-cost study, please contact for a phone consultation or email us at info@calmaretherapynj.com

Dr. Michael Cooney
Clinical Director
Calmare Therapy NJ USA
(201) 933.4440 | calmaretherapynj.com

 

Featured post

Mayo Clinic Doctors Tout Calmare Scrambler Therapy’s Chronic Pain Treatment Benefits

November 14, 2016

mayo clinicAs we’ve reported before, the Mayo Clinic, one of the world’s most respected medical research institutions,  has performed a number of clinical trials using scrambler therapy for chronic pain reduction.

In the 11.11.16  issue of their patient-targeted newsletter published last Friday, Mayo Clinic Health Newsletter, the institution published a lengthy overview about scrambler therapy and its significant pain reduction merits for people with a range of medication and treatment-resistant neuropathies.

mayo-health-letter-_best

 

Results from Dr. Charles Loprinzi’s scrambler therapy trial (2015)

Key Excerpt:

“Mayo Clinic doctors are optimistic about the pain scrambler. Based on research, and their own experience treating people, it appears the device can have good to dramatic results…”

We are (again) encouraged by the Mayo Clinic’s confidence to highlight scrambler therapy in their publications, which reach thousands of reader subscribers around the world.

To learn more about scrambler therapy treatment performed exclusively by Dr. Michael Cooney

Find out if your chronic pain condition might be right for Calmare Therapy.

Unlike other healthcare clinics, you can speak directly with Dr. Cooney about your medical history and previous chronic pain treatment efforts. At Calmare Therapy NJ USA, we will not recommend treatment for you if our team does not pre-determine you may a strong chance of sustained pain reduction.

Call us at (201) 933-4440 and let’s talk about your chronic pain condition. As you will discover after reading our Patient Case Studies, we treat newly diagnosed neuropathy as well as cases where patients have been battling this disease for decades.

Medscape reports on another positive clinical trial using Calmare for cancer pain

medscapeAnother Calmare Therapy clinical trial, conducted with people battling neuropathic pain as a result of chemotherapy treatment, has again shown  positive patient outcomes (significant lessening of pain) according to a new report published this week by Medscape, an affiliate of WebMD. (You have to register to read the article, but the process is free, quick and easy).

clinical trialCalmare Trial Key Points / Excerpts:

  • Scrambler therapy was not originally developed for the treatment of cancer-related neuropathic pain. Rather, it was developed for chronic pain and, indeed, has been used in many patients with noncancer-related pain, including low back pain.
  • Regardless of the type of neuropathic pain being treated, scores on the 11-point Numerical Rating Scale (NRS) decreased significantly from baseline to 1-month follow-up (P < .001).
  • The need for ‘rescue opioids’ dropped from a baseline dose of 5 mg to 0 mg at the end of the study.
  • No adverse side effects (“events”) that could have been associated with the therapy were reported.
  • A research team from the Massey Cancer Center at Virginia Commonwealth University in Richmond reported similar findings using the same cutaneous electro-stimulation device (scrambler therapy) for CIPN (J Pain Symptom Manage. 2010;40:883-891).
  • Some patients relapsed, but re-treatment and maintenance therapy (booster treatments) provided relief and, again, no adverse effects from treatment were observed.
  • Charles Loprinzi, MD, PhD, from the Mayo Clinic in Rochester, Minnesota, and colleagues conducted a trial with 37 CIPN patients and achieved similar study outcomes (Support Care Cancer. 2015 23:943-951).
  • Dr. Loprinzi stated that people have been slow to explore scrambler therapy use because “it sounds too good to be true…” He also reported to Medscape that efforts to conduct larger trials are ongoing, but it takes time and money to perform these trials.

The European Journal of Oncology Nursing also published an abstract of the study reported by Medscape.


New Brigham Young University research team to study Calmare scrambler therapy

trialsAdd another upcoming university-based, clinical research study about Calmare scrambler therapy to the list:

In addition to Johns Hopkins, Mayo Clinic, Massey Cancer Institute and others, BYU researchers will be conducting its own scrambler therapy study.

Dr. David Busath, heading up the research at Brigham Young University, stated, “I think the fooling the brain idea is a 1024px-BYU_Medallion_Logo.svglegitimate one…we’re convincing the brain in one area that this other area shouldn’t be hyperactive after all.”

Dr. Busath’s study protocol will consist of taking a patient  MRI for 20 minutes, then performing Calmare for 30 minutes, followed by another MRI.

Calmare provider and pain therapist Erick Bingham, not affiliated with the BYU study, stated in the article that the successful outcome for scrambler therapy patients depends on how the individual reacts after the very first treatment and believes patient response early on can be a predictor of the outcome. He says that 80 percent of the time, if the patient sustains a reduction in pain after that first treatment, they’re going to be a good candidate.

Dr. Bingham accurately noted that some patients will require periodic booster treatments while others remain pain-free with no need for future treatment.

Read the full article here

BYU scrambler therapy study candidates must have constant sharp pain in the hands or feet and not be on any anti-convulsant medication. Additionally, participants cannot have stents, pacemakers or other implants that would interfere with an MRI scan. Those wishing to apply for the two-phase study can contact Dr. Busath’s office at 801-422-8753.

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