<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03805113</url>
  </required_header>
  <id_info>
    <org_study_id>02/16</org_study_id>
    <nct_id>NCT03805113</nct_id>
  </id_info>
  <brief_title>Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis.</brief_title>
  <official_title>Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis. A Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Mutua de Terrassa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Mutua de Terrassa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Erosive arthritis (EA) is an unusual pathology. There is no definitive treatment and the&#xD;
      conventional one has little efficacy. Despite using magnetotherapy (MGT) as a treatment,&#xD;
      there is no evidence supporting its use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to evaluate the efficacy of MGT in patients suffering from hand EA,&#xD;
      compared to placebo, in terms of pain (assessed by Visual Analog Scale (VAS)) and&#xD;
      functionality (assessed by The Disabilities of the Arm, Shoulder and Hand (DASH) score)&#xD;
      during the treatment and after a 3-months period. Secondarily, rigidity (Modified Kapandji&#xD;
      Index), grip strength (JAMAR dynamometry) and quality of life (SF-36 questionnaire) were&#xD;
      assessed. Treatment safety will also be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2016</start_date>
  <completion_date type="Actual">February 2, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>Change from baseline pain at the end of the intervention and 3 months after the end of intervention.</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire</measure>
    <time_frame>Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Kapandji Index</measure>
    <time_frame>Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.</time_frame>
    <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)).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>JAMAR dynamometry</measure>
    <time_frame>Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 questionnaire</measure>
    <time_frame>Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Musculoskeletal Disease</condition>
  <condition>Musculoskeletal Pain</condition>
  <condition>Physical Therapy</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with magnetotherapy device 15 20-minute-sesions every consecutive working day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Treatment with misconnected magnetotherapy device 15 20-minute-sesions every consecutive working day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magnetotherapy device</intervention_name>
    <description>Use of magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Use of unplugged magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.</description>
    <arm_group_label>Control group placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of both sexes older than 18 years with symptomatic hand erosive&#xD;
             osteoarthritis for more than 6 months.&#xD;
&#xD;
          -  Patients receiving treatment or not for their hand pathology.&#xD;
&#xD;
          -  Patients suffering from hand chronic pain due to their pathology and scoring VAS equal&#xD;
             or greater than 4/10.&#xD;
&#xD;
          -  Patients who voluntarily signed the informed consent and agree to participate in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients with pacemaker or similar devices&#xD;
&#xD;
          -  Pacients with cognitive dysfunction.&#xD;
&#xD;
          -  Patients with psychiatric pathologies unable to comply with the treatment and&#xD;
             follow-up&#xD;
&#xD;
          -  Patients with active oncological and / or infectious pathology&#xD;
&#xD;
          -  Patients with previous magnetotherapy or paraffin treatment in the last year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Boada-Pladellorens, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Nostra Senyora de Meritxell</affiliation>
  </overall_official>
  <reference>
    <citation>Kwok WY, Kloppenburg M, Rosendaal FR, van Meurs JB, Hofman A, Bierma-Zeinstra SM. Erosive hand osteoarthritis: its prevalence and clinical impact in the general population and symptomatic hand osteoarthritis. Ann Rheum Dis. 2011 Jul;70(7):1238-42. doi: 10.1136/ard.2010.143016. Epub 2011 Apr 6.</citation>
    <PMID>21474485</PMID>
  </reference>
  <reference>
    <citation>Gazeley DJ, Yeturi S, Patel PJ, Rosenthal AK. Erosive osteoarthritis: A systematic analysis of definitions used in the literature. Semin Arthritis Rheum. 2017 Feb;46(4):395-403. doi: 10.1016/j.semarthrit.2016.08.013. Epub 2016 Aug 24.</citation>
    <PMID>27692966</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26620088</PMID>
  </reference>
  <reference>
    <citation>Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dincer F, Dziedzic K, Hauselmann HJ, Kaklamanis P, Kloppenburg M, Lohmander LS, Maheu E, Martin-Mola E, Pavelka K, Punzi L, Reiter S, Smolen J, Verbruggen G, Watt I, Zimmermann-Gorska I; ESCISIT. EULAR evidence-based recommendations for the diagnosis of hand osteoarthritis: report of a task force of ESCISIT. Ann Rheum Dis. 2009 Jan;68(1):8-17. doi: 10.1136/ard.2007.084772. Epub 2008 Feb 4.</citation>
    <PMID>18250111</PMID>
  </reference>
  <reference>
    <citation>Kanat E, Alp A, Yurtkuran M. Magnetotherapy in hand osteoarthritis: a pilot trial. Complement Ther Med. 2013 Dec;21(6):603-8. doi: 10.1016/j.ctim.2013.08.004. Epub 2013 Sep 8.</citation>
    <PMID>24280467</PMID>
  </reference>
  <reference>
    <citation>Anandarajah A. Erosive osteoarthritis. Discov Med. 2010 May;9(48):468-77.</citation>
    <PMID>20515616</PMID>
  </reference>
  <reference>
    <citation>Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16.</citation>
    <PMID>12809562</PMID>
  </reference>
  <reference>
    <citation>Spadoni GF, Stratford PW, Solomon PE, Wishart LR. The evaluation of change in pain intensity: a comparison of the P4 and single-item numeric pain rating scales. J Orthop Sports Phys Ther. 2004 Apr;34(4):187-93. doi: 10.2519/jospt.2004.34.4.187.</citation>
    <PMID>15128188</PMID>
  </reference>
  <reference>
    <citation>Garratt AM, Ruta DA, Abdalla MI, Buckingham JK, Russell IT. The SF36 health survey questionnaire: an outcome measure suitable for routine use within the NHS? BMJ. 1993 May 29;306(6890):1440-4. doi: 10.1136/bmj.306.6890.1440.</citation>
    <PMID>8518640</PMID>
  </reference>
  <reference>
    <citation>Lefevre-Colau MM, Poiraudeau S, Oberlin C, Demaille S, Fermanian J, Rannou F, Revel M. Reliability, validity, and responsiveness of the modified Kapandji index for assessment of functional mobility of the rheumatoid hand. Arch Phys Med Rehabil. 2003 Jul;84(7):1032-8. doi: 10.1016/s0003-9993(03)00128-x.</citation>
    <PMID>12881830</PMID>
  </reference>
  <reference>
    <citation>Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011 May;3(5):472-9. doi: 10.1016/j.pmrj.2010.10.025.</citation>
    <PMID>21570036</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>November 20, 2019</last_update_submitted>
  <last_update_submitted_qc>November 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Mutua de Terrassa</investigator_affiliation>
    <investigator_full_name>Anna Boada-Pladellorens</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Erosive arthritis</keyword>
  <keyword>Hands arthritis</keyword>
  <keyword>Magnetotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Musculoskeletal Pain</mesh_term>
    <mesh_term>Musculoskeletal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03805113
org study id: 02/16
nct id: NCT03805113
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual Analogue Scale (VAS)
time frame: Change from baseline pain at the end of the intervention and 3 months after the end of intervention.
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.
measure: 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.
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.
measure: Modified Kapandji Index
time frame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
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)).
measure: JAMAR dynamometry
time frame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
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.
measure: SF-36 questionnaire
time frame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
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.
arm group label: Intervention group
arm group type: Experimental
description: Treatment with magnetotherapy device 15 20-minute-sesions every consecutive working day.
arm group label: Control group placebo
arm group type: Placebo Comparator
description: Treatment with misconnected magnetotherapy device 15 20-minute-sesions every consecutive working day.
intervention type: Device
intervention name: Magnetotherapy device
description: Use of magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.
arm group label: Intervention group
intervention type: Device
intervention name: Placebo
description: Use of unplugged magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.
arm group label: Control group placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anna Boada-Pladellorens, MD
role: Principal Investigator
affiliation: Hospital Nostra Senyora de Meritxell
citation: Kwok WY, Kloppenburg M, Rosendaal FR, van Meurs JB, Hofman A, Bierma-Zeinstra SM. Erosive hand osteoarthritis: its prevalence and clinical impact in the general population and symptomatic hand osteoarthritis. Ann Rheum Dis. 2011 Jul;70(7):1238-42. doi: 10.1136/ard.2010.143016. Epub 2011 Apr 6.
PMID: 21474485
citation: Gazeley DJ, Yeturi S, Patel PJ, Rosenthal AK. Erosive osteoarthritis: A systematic analysis of definitions used in the literature. Semin Arthritis Rheum. 2017 Feb;46(4):395-403. doi: 10.1016/j.semarthrit.2016.08.013. Epub 2016 Aug 24.
PMID: 27692966
citation: 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.
PMID: 26620088
citation: Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dincer F, Dziedzic K, Hauselmann HJ, Kaklamanis P, Kloppenburg M, Lohmander LS, Maheu E, Martin-Mola E, Pavelka K, Punzi L, Reiter S, Smolen J, Verbruggen G, Watt I, Zimmermann-Gorska I; ESCISIT. EULAR evidence-based recommendations for the diagnosis of hand osteoarthritis: report of a task force of ESCISIT. Ann Rheum Dis. 2009 Jan;68(1):8-17. doi: 10.1136/ard.2007.084772. Epub 2008 Feb 4.
PMID: 18250111
citation: Kanat E, Alp A, Yurtkuran M. Magnetotherapy in hand osteoarthritis: a pilot trial. Complement Ther Med. 2013 Dec;21(6):603-8. doi: 10.1016/j.ctim.2013.08.004. Epub 2013 Sep 8.
PMID: 24280467
citation: Anandarajah A. Erosive osteoarthritis. Discov Med. 2010 May;9(48):468-77.
PMID: 20515616
citation: Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16.
PMID: 12809562
citation: Spadoni GF, Stratford PW, Solomon PE, Wishart LR. The evaluation of change in pain intensity: a comparison of the P4 and single-item numeric pain rating scales. J Orthop Sports Phys Ther. 2004 Apr;34(4):187-93. doi: 10.2519/jospt.2004.34.4.187.
PMID: 15128188
citation: Garratt AM, Ruta DA, Abdalla MI, Buckingham JK, Russell IT. The SF36 health survey questionnaire: an outcome measure suitable for routine use within the NHS? BMJ. 1993 May 29;306(6890):1440-4. doi: 10.1136/bmj.306.6890.1440.
PMID: 8518640
citation: Lefevre-Colau MM, Poiraudeau S, Oberlin C, Demaille S, Fermanian J, Rannou F, Revel M. Reliability, validity, and responsiveness of the modified Kapandji index for assessment of functional mobility of the rheumatoid hand. Arch Phys Med Rehabil. 2003 Jul;84(7):1032-8. doi: 10.1016/s0003-9993(03)00128-x.
PMID: 12881830
citation: Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011 May;3(5):472-9. doi: 10.1016/j.pmrj.2010.10.025.
PMID: 21570036
responsible party type: Principal Investigator
investigator affiliation: Hospital Mutua de Terrassa
investigator full name: Anna Boada-Pladellorens
investigator title: MD
mesh term: Osteoarthritis
mesh term: Musculoskeletal Pain
mesh term: Musculoskeletal Diseases
sharing ipd: Undecided