Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis.

NCT03805113 | Completed

• 1 other identifier: 02/16
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Musculoskeletal Disease; Musculoskeletal Pain; Physical Therapy

Keywords

Erosive arthritis; Hands arthritis; Magnetotherapy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

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

• Modified Kapandji Index

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

• JAMAR dynamometry

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

• SF-36 questionnaire

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Device: Magnetotherapy device

Control group placebo

PLACEBO COMPARATOR

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

Device: Placebo

Interventions

Magnetotherapy device DEVICE

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

Intervention group

Placebo DEVICE

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

Control group placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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

  PMID: 20515616 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Boada-Pladellorens, MD

  Hospital Nostra Senyora de Meritxell

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 15, 2019
• Study Start: January 2, 2016
• Primary Completion: May 1, 2017
• Study Completion: February 2, 2019
• Last Updated: November 21, 2019

Record last verified: 2019-11