Pain Relief Investigation of Neuromodulation Therapy in an Adult Fibromyalgia Population

Sponsor

Fralex Therapeutics (Industry)

Overall Status

Terminated

CT.gov ID

NCT00450905

Collaborator

PharmaNet (Industry), McDougall Scientific Limited (Other)

200

Enrollment

Locations

21.1

Duration (Months)

9.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Pain	Device: PRIMA Device	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Randomized Evaluation of a Low-Frequency Investigational Device Employing Neuromodulation Therapy in Patients With Fibromyalgia

Study Start Date :

Mar 1, 2007

Anticipated Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

Clinically significant pain reduction, evidenced by a statistically significant difference between active and placebo groups in percentage of subjects who achieve a pain reduction of at least 30% at week 12 as compared to the Baseline. []

Secondary Outcome Measures

Additional outcome measures will include mood alteration, sleep quality, improvement of physical functioning and relief medication usage by subjects in both groups. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Encinitas	California	United States	92024
2	Garden Grove	California	United States	92845
3	La Jolla	California	United States	92037
4	Lancaster	California	United States	93534
5	Murrieta	California	United States	92563
6	Palmdale	California	United States	93550
7	Gainsville	Florida	United States	32610
8	West Palm Beach	Florida	United States	33409
9	Winter Park	Florida	United States	32789
10	Lexington	Kentucky	United States	40503
11	Rochester	Minnesota	United States	55905
12	New York	New York	United States	10003
13	Rochester	New York	United States	14642-8604
14	Winston-Salem	North Carolina	United States	27103
15	Altoona	Pennsylvania	United States	16602
16	Seattle	Washington	United States	98104
17	Spokane	Washington	United States	99216
18	Hamilton	Ontario	Canada	L8N 3Z5
19	Ottawa	Ontario	Canada	K1H 1A2
20	Toronto	Ontario	Canada	M2N 6K7
21	Toronto	Ontario	Canada	M9W 4L6

Sponsors and Collaborators

Fralex Therapeutics
PharmaNet
McDougall Scientific Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00450905

Other Study ID Numbers:

F06001

First Posted:

Mar 22, 2007

Last Update Posted:

Oct 6, 2008

Last Verified:

Feb 1, 2008

Keywords provided by , ,

Chronic musculoskeletal pain secondary to Fibromyalgia

Additional relevant MeSH terms:

Fibromyalgia

Myofascial Pain Syndromes

Study Results

No Results Posted as of Oct 6, 2008