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Completed

NCT Number: NCT03805113

Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetotherapy device

Device

Use of magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.

PLACEBO

Device

Use of unplugged magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: Change from baseline pain at the end of the intervention and 3 months after the end of intervention.

    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.

Secondary outcomes

  1. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

    Time frame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.

    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.

  2. Modified Kapandji Index

    Time frame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.

    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)).

  3. JAMAR dynamometry

    Time frame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.

    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.

  4. SF-36 questionnaire

    Time frame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.

    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.

Sponsors and collaborators

Lead sponsor

Hospital Mutua de Terrassa

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jan 15, 2019
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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