Trial Outcomes & Findings for Evaluation of Magnetic Fields to Treat Fibromyalgia (NCT NCT01262131)

NCT ID: NCT01262131

Last Updated: 2011-07-01

Results Overview

Minimum scale value is '0' which represents 'no pain at all' and is the best outcome. Maximum scale value is '10 which represents the 'worst pain imaginable' and is the worse outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: 2 weeks (baseline to end of treatment)
• Results posted on: 2011-07-01

Participant Flow

Participant milestones

Measure	Resonator Protocol A Application of magnetic fields using the Resonator device protocol A	Resonator Protocol B Application of magnetic fields using the Resonator device treatment protocol B	Inactive Resonator Application of inactive magnetic fields using the Resonator device
Overall Study STARTED	5	4	4
Overall Study COMPLETED	5	4	4
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Magnetic Fields to Treat Fibromyalgia

Baseline characteristics by cohort

Measure	Resonator Protocol A n=5 Participants Application of magnetic fields using the Resonator device protocol A	Resonator Protocol B n=4 Participants Application of magnetic fields using the Resonator device treatment protocol B	Inactive Resonator n=4 Participants Application of inactive magnetic fields using the Resonator device	Total n=13 Participants Total of all reporting groups
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 2 weeks (baseline to end of treatment)

Population: Analysis was by intention to treat which included all enrolled subjects in this case to study completion.

Minimum scale value is '0' which represents 'no pain at all' and is the best outcome.

Maximum scale value is '10 which represents the 'worst pain imaginable' and is the worse outcome.

Outcome measures

Measure	Resonator Protocol A n=5 Participants Application of magnetic fields using the Resonator device protocol A	Resonator Protocol B n=4 Participants Application of magnetic fields using the Resonator device treatment protocol B	Inactive Resonator n=4 Participants Application of inactive magnetic fields using the Resonator device
Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale.	-3.69 Scores on a scale Standard Deviation 1.2	-3.08 Scores on a scale Standard Deviation 1.2	-1.97 Scores on a scale Standard Deviation 1

Adverse Events

Resonator Protocol A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Resonator Protocol B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inactive Resonator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Allen S. Braswell CEO

Pico-Tesla Magnetic Therapies, LLC

Phone: 303 795-3222

Email: abraswell@pico-tesla.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place