April 11, 2018

CLINICAL TRIAL – DIAGNOSED FIBROMYALGIA

Study 

To Measure Chronic Pain Reduction in Patients Diagnosed with Treatment-Resistant Fibromyalgia after Administering 3-5 Calmare (Scrambler Therapy) Treatments

Phase

Pilot

What is Fibromyalgia?

Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. Researchers believe that fibromyalgia amplifies painful sensations by affecting the way your brain processes pain signals.

Calmare scrambler therapy is a drug-free, non-invasive, FDA-cleared therapy that painlessly scrambles a misfiring pain message from the brain, suggesting there is pain, when, in fact, there is not.

Purpose of the Clinical Trial

To document the viability of using scrambler therapy as a pain management solution to significantly reduce or eliminate neuropathic pain in patients diagnosed with Fibromyalgia.

Study Conducted by

Michael J. Cooney, D.C., Clinical Director

Rutherford Allied Medical Group  | Calmare Therapy NJ USA

 Location

323 Union Ave., Rutherford, New Jersey (10 miles from New York City)

Trial Start Date

Monday, April 23, 2018 

Testing Period

After a personal consultation and evaluation by Dr. Michael Cooney, selected trial candidates will undergo 3 to 5 treatments, once daily, lasting approximately 35 minutes. Additional treatments will be at the discretion of the clinical director.

Calmare Therapy NJ Background

Calmare Therapy NJ / Rutherford Allied Medical Group, is one of only eight certified providers of Calmare Pain Therapy Treatment®, 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 the Calmare Fibromyalgia Clinical Trial

We are conducting a no-cost, 3 or more treatments (one 35-minute daily therapy session) clinical trial study for pre-qualified patients suffering from diagnosed fibromyalgia FMS to determine the efficacy of scrambler therapy as a viable treatment solution for condition-induced neuropathy.

Trial participants are selected at the discretion of Dr. Michael Cooney, clinical director, Calmare Therapy NJ USA | Application Form

Eligibility Criteria

Selected clinical trial volunteers must be available to undergo the protocol once per day. We will make every effort to schedule daily appointments at a convenient time for participants.

Travel, daily transportation, meals and accommodations are at the trial participant’s expense.

Contraindications

We are seeking trial candidates with few or no additional medical conditions, in order to maximize the treatment and outcome of the FMS condition exclusively.

Candidates are not eligible for the trial if they have the following medical conditions, devices or prescribed medications:

  • Pacemaker
  • Automatic implantable cardioverter-defibrillator (AICD)
  • Pregnancy
  • Epilepsy
  • Heart conditions
  • Anticonvulsants
  • Antidepressants

Informed Consent

Clinical trial volunteers who are selected for the study are asked to sign the Informed Consent Form. Signing this document does not require participants to remain for the duration of the study, however.

People 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, the researchers must inform the participants.

Publicity

Calmare Therapy NJ reserves the right to publish data about any participant’s trial outcome. We will not include your name or image, at your request.

To Apply / Contact Us / For More Information

The deadline for clinical trial applications is Friday, May 27, 2018.

To apply for the trial, click here to complete and scan the attached application form and return it to calmarenj@gmail.com or fax to (201) 933-8159.

For questions about the trial, please contact:

Dr. Michael Cooney

Clinical Director

Calmare Therapy NJ / Rutherford Allied Medical Group

(201) 933.4440   |   calmarenj@gmail.com

 

 

 

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