Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000515291
Ethics application status
Approved
Date submitted
14/11/2017
Date registered
9/04/2018
Date last updated
30/03/2022
Date data sharing statement initially provided
30/03/2022
Date results information initially provided
30/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of magnetic fields in treating fatigue in patients with multiple sclerosis.
Scientific title
Effectiveness of magnetic fields for the treatment of fatigue in patients with multiple sclerosis.
Secondary ID [1] 293366 0
‘Nil known’
Universal Trial Number (UTN)
U1111-1205-1082
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 305487 0
Condition category
Condition code
Inflammatory and Immune System 304742 304742 0 0
Autoimmune diseases
Neurological 305923 305923 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 299621 0
Rehabilitation
Comparator / control treatment
The control group receive sham exposures to magnetic fields. 20 sessions of 45 minutes, 5 days per week such as experimental group. In this group participants received a sham-placebo stimulus (mat B) for the same number of sessions and period of time than patients in the magnetotherapy group. Contact with power cable was possible with this sham mat, thus the indicator lamp was on during the whole session
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 each 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.
Control group
Placebo

Outcomes
Primary outcome [1] 303956 0
Fatigue assessed with Fatigue Severity Scale (FSS).
Timepoint [1] 303956 0
Before the intervention, at the end of the intervention and at 3 months after intervention.
Primary outcome [2] 303957 0
Fatigue assessed with Modified Fatigue Impact Scale (MFIS).
Timepoint [2] 303957 0
Before the intervention, at the end of the intervention and at 3 months after intervention.
Secondary outcome [1] 340539 0
Quality of life assessed with MusiQoL.
Timepoint [1] 340539 0
Before the intervention, at the end of the intervention and at 3 months after intervention.
Secondary outcome [2] 340540 0
Temporal and spatial gait parameters (velocity, step-length difference, functional ambulation performance, step-time difference and cadence) assessed by GAITRite electronic walkway. This is a composite secondary outcome.
Timepoint [2] 340540 0
Before the intervention, at the end of the intervention and at 3 months after intervention.
Secondary outcome [3] 408187 0
Depression levels through the Beck Depression Inventory II (BDI-II).
Timepoint [3] 408187 0
Before the intervention, at the end of the intervention and at 3 months after intervention.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method used to generate the sequence is “MAS Version 2.1 @Glazo Wellcome"
This program did a randomized block: A/B
Block design: AB
Block size: 2
Block number: 20
Sample size: 40
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The estimated sample size is 40, calculated with the G Power software

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/04/2018
Actual
3/05/2018
Date of last participant enrolment
Anticipated
Actual
16/09/2019
Date of last data collection
Anticipated
Actual
20/12/2019
Sample size
Target
60
Accrual to date
Final
44
Recruitment outside Australia
Country [1] 9360 0
Spain
State/province [1] 9360 0
Seville

Funding & Sponsors
Funding source category [1] 297990 0
Hospital
Name [1] 297990 0
Hospital Universitario Virgen Macarena
Country [1] 297990 0
Spain
Primary sponsor type
Hospital
Name
Hospital Universitario Virgen Macarena
Address
Dr. Frediani Avenue 3, Seville 41009- Spain.
Country
Spain
Secondary sponsor category [1] 297056 0
None
Name [1] 297056 0
Address [1] 297056 0
Country [1] 297056 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299029 0
Comite de Etica de la Investigacion de Centro Hospital Universitario Virgen Macarena.
Ethics committee address [1] 299029 0
Avenida Doctor Frediani 3- Unidad de Investigación 2ª Planta, Seville 41071-Spain.
Ethics committee country [1] 299029 0
Spain
Date submitted for ethics approval [1] 299029 0
29/04/2013
Approval date [1] 299029 0
02/05/2013
Ethics approval number [1] 299029 0
2077

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2196 2196 0 0
/AnzctrAttachments/373996-Ethics approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 79042 0
Ms Anja Hochsprung
Address 79042 0
Hospital Universitario Virgen Macarena.
Calle Fray Isidoro de Sevilla 1, 41003.
Seville
Country 79042 0
Spain
Phone 79042 0
+34 671562074
Fax 79042 0
Email 79042 0
[email protected]
Contact person for public queries
Name 79043 0
Ms Anabel Granja Dominguez
Address 79043 0
Hospital Universitario Virgen Macarena
Calle Fray Isidoro de Sevilla 1, 41003.
Seville
Country 79043 0
Spain
Phone 79043 0
+34 645170750
Fax 79043 0
Email 79043 0
[email protected]
Contact person for scientific queries
Name 79044 0
Ms Anabel Granja Dominguez
Address 79044 0
Hospital Universitario Virgen Macarena
Calle Fray Isidoro de Sevilla 1, 41003.
Seville
Country 79044 0
Spain
Phone 79044 0
+34 645170750
Fax 79044 0
Email 79044 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.