Pain Relief Investigation of Neuromodulation Therapy in an Adult Fibromyalgia Population

Fralex Therapeutics

Status and phase

Terminated

Phase 3

Conditions

Fibromyalgia

Pain

Treatments

Device: PRIMA Device

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00450905

F06001

Details and patient eligibility

About

This study is being performed to determine the safety and efficacy of Fralex Neuromodulation Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal pain associated with Fibromyalgia.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of chronic musculoskeletal pain of at least six months duration secondary to FMS using American College of Rheumatology (ACR) criteria and with the minimum of 11 of 18 defined tender points, measured by dolorimeter at a threshold of up to 4 kg of pressure
Males and females, 18 years and older
Able to complete assessment index forms unaided by caregiver/interpreter
Pain score of 4 or greater on the Numerical Rating Scale (NRS), averaged from the Baseline Period scores recorded on the 7 days immediately prior to randomization
Demonstration of stabilized pain scores as measured on the NRS during the Baseline Period (Days -7 to -1)
Able to tolerate prohibition of all medications for pain, depression and sleep disorders except for acetaminophen (up to 4 g/day) and cardiac aspirin (up to 325 mg/day) demonstrated for the Stabilization and Baseline Periods prior to randomization
Able and willing to provide a written informed consent

Exclusion criteria

Unwilling or unable to sign an informed consent, or to comply with the protocol
Evidence of inflammatory rheumatic disease, secondary fibromyalgia, or other severe painful disorders that might confound assessment of FMS pain
Currently under treatment (pharmacological or cognitive therapy) for a Major Depressive Episode (MDE) or has demonstrated suicidal ideation in the past
History or current treatment of migraine, tension or cluster headache requiring regular medication
History or current treatment of seizure disorder
History or current treatment of cancer with the exception of basal cell carcinoma and cervical dysplasia
Cognitive dysfunction or personality disorder which would preclude self-directed treatment, self assessment and / or diary completion
Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation
Hearing aids, metal implants (excludes dental work) above mid torso or in the cranium (e.g. plates, implants or clips). (Metal implants in parts of the body below mid-torso, such as knee or hips replacements, clips, screws or plates to stabilize fractures are acceptable)
Pacemakers, defibrillators, implanted neurostimulators, implanted drug pumps or other electrical implanted devices
Insufficient knowledge of English to complete the self-assessment forms
History of or current drug or alcohol abuse
History of abuse of a previous physician relationship or the medical system
Receiving disability insurance, applying for disability insurance, or engaged in litigation related to FMS
Use of an investigational drug or device in a controlled study within 30 days
Pregnancy (U.S. sites only)
Breastfeeding or intending to breastfeed (U.S. sites only)