May 3, 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 (Rolling Admission)
May 21, 2018 to August 31, 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
There is no fee to participate.
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