Clinical trial NCT03805113: Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis.
Official title: Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disease
Musculoskeletal Pain
Physical Therapy
Keywords: Erosive arthritis
Hands arthritis
Magnetotherapy
Lead sponsor: Hospital Mutua de Terrassa
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Change from baseline pain at the end of the intervention and 3 months after the end of intervention.
Secondary outcomes:
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
measure: Modified Kapandji Index
timeFrame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
measure: JAMAR dynamometry
timeFrame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
measure: SF-36 questionnaire
timeFrame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Nostra Senyora de Meritxell
name: Anna Boada-Pladellorens, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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: 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: Anandarajah A. Erosive osteoarthritis. Discov Med. 2010 May;9(48):468-77.
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: 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: 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: 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: 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.