Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis.

Study Overview
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Brief Summary
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Erosive arthritis (EA) is an unusual pathology. There is no definitive treatment and the conventional one has little efficacy. Despite using magnetotherapy (MGT) as a treatment, there is no evidence supporting its use.

Detailed Description
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The aim of the study is to evaluate the efficacy of MGT in patients suffering from hand EA, compared to placebo, in terms of pain (assessed by Visual Analog Scale (VAS)) and functionality (assessed by The Disabilities of the Arm, Shoulder and Hand (DASH) score) during the treatment and after a 3-months period. Secondarily, rigidity (Modified Kapandji Index), grip strength (JAMAR dynamometry) and quality of life (SF-36 questionnaire) were assessed. Treatment safety will also be evaluated.

Official Title
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Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis. A Randomized Clinical Trial.

Conditions
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Musculoskeletal Disease, Musculoskeletal Pain, Physical Therapy

Intervention / Treatment
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* Device: Magnetotherapy device
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes older than 18 years with symptomatic hand erosive osteoarthritis for more than 6 months. Patients receiving treatment or not for their hand pathology. Patients suffering from hand chronic pain due to their pathology and scoring VAS equal or greater than 4/10. Patients who voluntarily signed the informed consent and agree to participate in the study. Exclusion Criteria: Pregnancy Patients with pacemaker or similar devices Pacients with cognitive dysfunction. Patients with psychiatric pathologies unable to comply with the treatment and follow-up Patients with active oncological and / or infectious pathology Patients with previous magnetotherapy or paraffin treatment in the last year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Treatment with magnetotherapy device 15 20-minute-sesions every consecutive working day. | Device: Magnetotherapy device<br>* Use of magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.<br>|
| Placebo Comparator: Control group placebo<br>Treatment with misconnected magnetotherapy device 15 20-minute-sesions every consecutive working day. | Device: Placebo<br>* Use of unplugged magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured, like pain. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points: one meaning no pain and the opposite one meaning the worst pain. | Change from baseline pain at the end of the intervention and 3 months after the end of intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. | Before starting the intervention, at the end of the intervention and 3 months after the end of intervention. | 
| Modified Kapandji Index | Modified Kapandji Index is a rate of hand mobility assessment. The final result is obtained by adding the results of the 3 tests: test opposition of the thumb (It consists of touching the 4 fingers with the thumb pulp. It scores from 0 to 10); fingers flexion test (It consists of following the thumb with each of the fingers, scoring from 0 (impossible to achieve) to 20 (completely achieved)); fingers extension test (It consists of stretching the hand on a table and get the maximum contact with the surface of the table, scoring from 0 (impossible to achieve) to 20 (completely achieved)). | Before starting the intervention, at the end of the intervention and 3 months after the end of intervention. | 
| JAMAR dynamometry | JAMAR dynamometry is a valid and reliable instrument to measure the muscular strength of the hands. It is needed to be well performed. The patient is placed in a sitting position with the elbows flexed to 90 degrees without supporting them and the JAMAR is approached to him to be able to make 3 strength determinations with each hand. The final value is extracted from the average of the 3 values of each hand. | Before starting the intervention, at the end of the intervention and 3 months after the end of intervention. | 
| SF-36 questionnaire | SF-36 is a self-administered questionnaire that can be answered in approximately 10 minute. It quantifies thepatients health status using 8 scales that measure three aspects: functional status, well-being and overall health assessment. 8 numbers between 0 and 100 are obtained. The higher score, the better health status is. | Before starting the intervention, at the end of the intervention and 3 months after the end of intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erosive arthritis, Hands arthritis, Magnetotherapy