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Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis.

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ClinicalTrials.gov Identifier: NCT03805113
Recruitment Status : Completed
First Posted : January 15, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Anna Boada-Pladellorens, Hospital Mutua de Terrassa

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Disease Musculoskeletal Pain Physical Therapy Device: Magnetotherapy device Device: Placebo Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis. A Randomized Clinical Trial.
Actual Study Start Date : January 2, 2016
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : February 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
Treatment with magnetotherapy device 15 20-minute-sesions every consecutive working day.
 Device: Magnetotherapy device
Use of magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.
Placebo Comparator: Control group placebo
Treatment with misconnected magnetotherapy device 15 20-minute-sesions every consecutive working day.
 Device: Placebo
Use of unplugged magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805113


Sponsors and Collaborators
Hospital Mutua de Terrassa
Investigators
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Principal Investigator: Anna Boada-Pladellorens, MD Hospital Nostra Senyora de Meritxell
More Information
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Publications:

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Responsible Party: Anna Boada-Pladellorens, MD, Hospital Mutua de Terrassa
ClinicalTrials.gov Identifier: NCT03805113    
Other Study ID Numbers: 02/16
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Anna Boada-Pladellorens, Hospital Mutua de Terrassa:
Erosive arthritis
Hands arthritis
Magnetotherapy
Additional relevant MeSH terms:
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Osteoarthritis
Musculoskeletal Pain
Musculoskeletal Diseases
Arthritis
Joint Diseases
 Rheumatic Diseases
Muscular Diseases
Pain
Neurologic Manifestations