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Trial registered on ANZCTR


Registration number
ACTRN12617001499370
Ethics application status
Approved
Date submitted
31/08/2017
Date registered
24/10/2017
Date last updated
23/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of pain treatment by modulated electromagnetic signals in Monopolar Dielectric application in women with Fibromyalgia.
Scientific title
Efficacy of pain treatment by modulated electromagnetic signals in Monopolar Dielectric application in women with Fibromyalgia.
Secondary ID [1] 292794 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia 304603 0
Condition category
Condition code
Anaesthesiology 303928 303928 0 0
Pain management
Physical Medicine / Rehabilitation 303929 303929 0 0
Physiotherapy
Musculoskeletal 304295 304295 0 0
Other muscular and skeletal disorders
Neurological 304296 304296 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two study arms: Intervention and control.

-Intervention group will receive eight treatment sessions of 20 minutes of duration along two weeks (from Monday to Friday the first week and Monday, Wednesday and Friday the second week). In each of them, a Dielectric Monopolar Electromagnetic Signals Device will be used to treat the patient upper trapezius by massaging and heating (38 degrees Celsius) it with the device applicator, which will use a 30 volts and 800-900 kilohertz range emission. The pressure used will be of 2kg in order to reach pressure enough without producing pain. The treatment will be held on a wood portable physiotherapy table, situated in a climatized room. The patients will be on the table in prone position all along the treatment. A physiotherapist with over 5 years of experience will deliver the treatment.

In order to maintain adherence to the treatment, the physiotherapist who treat the intervention group will remember the patients to come to treatment by phoning them the day before.
Intervention code [1] 299038 0
Treatment: Devices
Comparator / control treatment
Control group will receive their standard cares: same quantity of exercise that they usually do, same drugs they usually take and same daily activities.
Control group
Active

Outcomes
Primary outcome [1] 303269 0
Changes in upper trapezius pain score with Visual Analogue Scale
Timepoint [1] 303269 0
Immediately before and after the first and the last treatment session, which was the timepjoint used for sample size calculation
Primary outcome [2] 303270 0
Changes in general body pain score with Visual Analogue Scale
Timepoint [2] 303270 0
Immediately before the first session of treatment and after the last one.
Secondary outcome [1] 338484 0
Changes in Anxiety and Depression measured with HADS scale
Timepoint [1] 338484 0
Immediately before the first session of treatment and after the last one.
Secondary outcome [2] 338485 0
Changes in quality of life impact measured with ICAF questionnaire
Timepoint [2] 338485 0
Immediately before the first session of treatment and after the last one.
Secondary outcome [3] 338486 0
Changes in quality of sleep measured with Visual Analogue Scale
Timepoint [3] 338486 0
Immediately before the first session of treatment and after the last one.

Eligibility
Key inclusion criteria
Women diagnosed of fibromyalgia by the ACR Criteria of 1990, in treatment for the fibromyalgia syndrome symptoms (pain, depression, fatigue...)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-To have make any change in medication intake in the previous SIX months before the study begins or during it.
-Being or have being under humoral treatment in last two years
-To suffer alterations of thermal sensivity
-To present any of the contraindications of the treatment device: be carriers of pacemakers, heart valves or any other implanted electrical or electronic device, be pregnant, have active or acute hemorrhagic areas, have open wounds or undiagnosed skin pathologies.

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)
Simple randomization using a randomization table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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 sample size was calculated by the software ENE 3.0, using as reference data from the study of Sutbeyaz ST et al. (2009) to find differences between two samples with 1% of signification and 90% statistical power , resulting a total of 26 patients. Taking into account expected losses of 12.5% (Sutbeyaz ST, 2009), a minimum of 30 patients should be included, so it will eventually include about 50 to ensure representativeness.

To carry the statistical analysis of the data, MedCalc software version 16.4.3 for Windows will be used, considering a statically significant a 0,05 value. A homogeneity analysis will be done by Shapiro-Wilk test, noting the values as media and standard deviation.

General and upper trapezius pain variables will be analyzed with ANOVA of repeated measures to detect changes in pain along the treatment, using as intra subject factor the time and as inter subject factor the treatment received by the patient. After that, Cohen's d will be calculated to measured the effect size of each treatment before and after the intervention.

In quality of life impact, depression, anxiety and quality of sleep variables, an ANOVA test will be carried considering treatment group as factor. To check the possible differences between before and after the intervention on each arm, a T test will be calculated. Cohen's d will be calculated to measure the effect size of the treatment on each variable.

A Spearman correlation analysis will be done to check the possible relations among the variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/11/2017
Actual
3/09/2018
Date of last participant enrolment
Anticipated
8/10/2018
Actual
8/10/2018
Date of last data collection
Anticipated
22/10/2018
Actual
22/10/2018
Sample size
Target
50
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 9177 0
Spain
State/province [1] 9177 0
Malaga

Funding & Sponsors
Funding source category [1] 297426 0
Commercial sector/Industry
Name [1] 297426 0
Biotronic Advance Develops
Country [1] 297426 0
Spain
Primary sponsor type
Individual
Name
Alfonso Javier Ibañez Vera
Address
Universidad de Jaen
Campus de las Lagunillas s/n
23071, Jaen (Jaen). SPAIN
Edificio B3, Despacho 270
Country
Spain
Secondary sponsor category [1] 296421 0
None
Name [1] 296421 0
Address [1] 296421 0
Country [1] 296421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298534 0
Comité de Ética de la Investigación provincial de Málaga
Ethics committee address [1] 298534 0
Hospital Regional Universitario.
7ª planta Pabellón A.
Avda. Carlos Haya s/n.
29010-Málaga.
Ethics committee country [1] 298534 0
Spain
Date submitted for ethics approval [1] 298534 0
22/06/2017
Approval date [1] 298534 0
12/07/2017
Ethics approval number [1] 298534 0
Not applicable

Summary
Brief summary
Fibromyalgia is one of the most important health problem in developed countries with a prevalence of 2,1% and health costs growing every year. Patients with fibromyalgia suffer pain all over the body and many other symptoms such as depression, headache, irritable colon, painful menstruation, irritability, thermal sensitivity, fatigue, joint stiffness and sleep disturbances. At the moment, fibromyalgia lacks of an effective treatment, among others things because there is no consensus about its etiology. Its approach consist on symptomatic treatment of pain and the associated symptoms by medication. The poor results of medication at relief pain at long time and the adverse effects as risk of dependence and tolerance of some drugs make necessary to find alternative safer and good quality treatments.

Dielectric Monopolar Electromagnetic Signals treatment has been successfully tried to treat neuropathic pain and some types of chronic pain, presenting no adverse effects and with a reduce cost of maintenance, reasons that show it has an interesting alternative for fibromyalgia treatment.

Hypothesis
-Dielectric Monopolar Electromagnetic Signals (DMES) treatment will improve at short time the upper trapezius and the general pain of fibromyalgia patients.
-DMES treatment will improve at short time the quality of life impact, the depression, the anxiety and the quality of sleep in fibromyalgia patients.
-Standard treatment added to DMES treatment will be more effective than only the standard treatment of the patients.

Objectives:
-To check the efficacy at short time of DMES treatment in releasing upper trapezius and general pain in fibromyalgia patients.
-To check the influence of DMES treatment on quality of life impact, depression, anxiety and quality of sleep in fibromyalgia patients.
-To measured if DMES treatment added to the standard treatment of patients get bigger improvement in subjects variables than only the standard treatment of patients.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2010 2010 0 0
/AnzctrAttachments/373580-Comité Ético OEDCM.pdf (Ethics approval)

Contacts
Principal investigator
Name 77378 0
Prof Alfonso Javier Ibañez Vera
Address 77378 0
Universidad de Jaen
Paraje de las Lagunillas s/n
Edificio B3, despacho 270
23071, Jaen (Jaen) SPAIN
Country 77378 0
Spain
Phone 77378 0
+34953213519
Fax 77378 0
Email 77378 0
[email protected]
Contact person for public queries
Name 77379 0
Alfonso Javier Ibañez Vera
Address 77379 0
Universidad de Jaen
Paraje de las Lagunillas s/n
Edificio B3, despacho 270
23071, Jaen (Jaen) SPAIN
Country 77379 0
Spain
Phone 77379 0
+34953213519
Fax 77379 0
Email 77379 0
[email protected]
Contact person for scientific queries
Name 77380 0
Alfonso Javier Ibañez Vera
Address 77380 0
Universidad de Jaen
Paraje de las Lagunillas s/n
Edificio B3, despacho 270
23071, Jaen (Jaen) SPAIN
Country 77380 0
Spain
Phone 77380 0
+34953213519
Fax 77380 0
Email 77380 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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