AzTrials
AzTrials

Musculoskeletal DiseaseNCT03805113

Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis.

A study testing Magnetotherapy device in people with Musculoskeletal Disease and Musculoskeletal Pain, run by Hospital Mutua de Terrassa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Magnetotherapy device
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19 participants
Where
No sites listed yet
Study dates
2 Jan 2016to 2 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Being tested
Magnetotherapy device, Placebo
Keywords
Erosive arthritis, Hands arthritis, Magnetotherapy
Medical subject headings
Musculoskeletal Diseases, Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetotherapy deviceDevice

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

  • PlaceboDevice

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

Study groups in NCT03805113
Study groupRoleWhat they receive
Intervention groupExperimentalTreatment with magnetotherapy device 15 20-minute-sesions every consecutive working day.
Receives: Device: Magnetotherapy device
Control group placeboPlacebo comparatorTreatment with misconnected magnetotherapy device 15 20-minute-sesions every consecutive working day.
Receives: Device: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (4)

  1. 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.

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

  2. 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)).

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

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start2 Jan 2016
  3. Primary completion1 May 2017
  4. Study completion2 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03805113
Sponsor's protocol ID
02/16
Status last verified
Nov 2019
First submitted
10 Jan 2019
Last updated
21 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 21474485

  • 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.

    PubMed 27692966

  • 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.

    PubMed 26620088

  • 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.

    PubMed 18250111

  • 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.

    PubMed 24280467

  • Anandarajah A. Erosive osteoarthritis. Discov Med. 2010 May;9(48):468-77.

    PubMed 20515616

  • 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.

    PubMed 12809562

  • 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.

    PubMed 15128188

  • 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.

    PubMed 8518640

  • 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.

    PubMed 12881830

  • 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.

    PubMed 21570036

Questions about this trial

What is this clinical trial studying?

A study testing Magnetotherapy device in people with Musculoskeletal Disease and Musculoskeletal Pain, run by Hospital Mutua de Terrassa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03805113, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.

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