Effectiveness of magnetic fields in treating fatigue in patients with multiple sclerosis.

Effectiveness of magnetic fields for the treatment of fatigue in patients with multiple sclerosis.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000515291

Enrollment

Registered

2018-04-09

Start date

2018-05-03

Completion date

2019-09-16

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is explore the effectiveness of magnetic field therapy (pulsed low frequency magnetic field) in fatigue in patients with multiple sclerosis. How this intervention can influence in the fatigue and the quality of life in these subjects. Electromagnetic field therapy has been reported to be beneficial in patients with multiple sclerosis with significant fatigue. The intervention consisted of magnetic field (pulsed low frequency magnetic field) with “Duoforte-Renaissance” system for 45 minutes five days per week for 1 month to placebo for 4 weeks without treatment.

Interventions

All subjects receive 20 sessions of 40-45 minutes, 5 days a week, under physiotherapist supervision. The instrument is Duoforte Reuaissance system, is a low frecuency magnetic fields with MS specific program, the frequency will be 15-20-25-30 Hz every 10 minutes. The intensity (Magnetic field induction):100%= 25 Mt=250 Gauss, minimum/ 35 mT=350 Gauss, maximun. The physiotherapist will be who administer the intervention. The mode of administration will be one-on-one.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

- Subject with a definitive diagnosis of Relapsing-Remitting Multiple Sclerosis with a stable disease over the previous four months; - 18 years of age or older; - EDSS score less than or equal to 5,5; - Cognitive capacity to complete the assessment and the treatment protocol; - Reporting fatigue assesed with MFIS and FSS scale.

Exclusion criteria

- Pregnancy - No cognitive capacity to complete the assessment and the treatment protocol; -EDSS score more than 5.5 - Use of drugs and medication specifically prescribed to decrease fatigue. - MS relapse during treatment (defined as any change in symptoms according to the EDSS evaluation) within the month before data collection -Diagnosed psychiatric disorders; epilepsy; concomitant chronic disorders that may evoke fatigue, such as fibromyalgia; and possible secondary causes of fatigue.

Outcome results