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Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis.

Primary Purpose

Musculoskeletal Disease, Musculoskeletal Pain, Physical Therapy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnetotherapy device
Placebo
Sponsored by
Hospital Mutua de Terrassa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Disease focused on measuring Erosive arthritis, Hands arthritis, Magnetotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention group

    Control group placebo

    Arm Description

    Treatment with magnetotherapy device 15 20-minute-sesions every consecutive working day.

    Treatment with misconnected magnetotherapy device 15 20-minute-sesions every consecutive working day.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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)).
    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.
    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.

    Full Information

    First Posted
    January 10, 2019
    Last Updated
    November 20, 2019
    Sponsor
    Hospital Mutua de Terrassa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03805113
    Brief Title
    Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis.
    Official Title
    Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis. A Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2, 2016 (Actual)
    Primary Completion Date
    May 1, 2017 (Actual)
    Study Completion Date
    February 2, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Mutua de Terrassa

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Musculoskeletal Disease, Musculoskeletal Pain, Physical Therapy
    Keywords
    Erosive arthritis, Hands arthritis, Magnetotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Treatment with magnetotherapy device 15 20-minute-sesions every consecutive working day.
    Arm Title
    Control group placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Treatment with misconnected magnetotherapy device 15 20-minute-sesions every consecutive working day.
    Intervention Type
    Device
    Intervention Name(s)
    Magnetotherapy device
    Intervention Description
    Use of magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.
    Intervention Type
    Device
    Intervention Name(s)
    Placebo
    Intervention Description
    Use of unplugged magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale (VAS)
    Description
    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.
    Time Frame
    Change from baseline pain at the end of the intervention and 3 months after the end of intervention.
    Secondary Outcome Measure Information:
    Title
    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
    Description
    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.
    Time Frame
    Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
    Title
    Modified Kapandji Index
    Description
    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)).
    Time Frame
    Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
    Title
    JAMAR dynamometry
    Description
    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.
    Time Frame
    Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
    Title
    SF-36 questionnaire
    Description
    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.
    Time Frame
    Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anna Boada-Pladellorens, MD
    Organizational Affiliation
    Hospital Nostra Senyora de Meritxell
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
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    21474485
    Citation
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    Haugen IK, Mathiessen A, Slatkowsky-Christensen B, Magnusson K, Boyesen P, Sesseng S, van der Heijde D, Kvien TK, Hammer HB. Synovitis and radiographic progression in non-erosive and erosive hand osteoarthritis: is erosive hand osteoarthritis a separate inflammatory phenotype? Osteoarthritis Cartilage. 2016 Apr;24(4):647-54. doi: 10.1016/j.joca.2015.11.014. Epub 2015 Nov 24.
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