Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis.

NCT ID: NCT03805113

Last Updated: 2019-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-02

Study Completion Date

2019-02-02

Brief Summary

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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

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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.

Conditions

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Musculoskeletal Disease Musculoskeletal Pain Physical Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Magnetotherapy device

Intervention Type DEVICE

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

Control group placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

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

Interventions

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Magnetotherapy device

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

Intervention Type DEVICE

Placebo

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Mutua de Terrassa

OTHER

Sponsor Role lead

Responsible Party

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Anna Boada-Pladellorens

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Boada-Pladellorens, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Nostra Senyora de Meritxell

References

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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.

Reference Type BACKGROUND
PMID: 21474485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27692966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26620088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18250111 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24280467 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 20515616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12809562 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15128188 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8518640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12881830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21570036 (View on PubMed)

Other Identifiers

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02/16

Identifier Type: -

Identifier Source: org_study_id

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