- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03805113
Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis.
November 20, 2019 updated by: Anna Boada-Pladellorens, Hospital Mutua de Terrassa
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
Treatment with magnetotherapy device 15 20-minute-sesions every consecutive working day.
|
Use of magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.
|
PLACEBO_COMPARATOR: Control group placebo
Treatment with misconnected magnetotherapy device 15 20-minute-sesions every consecutive working day.
|
Use of unplugged magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: Change from baseline pain at the end of the intervention and 3 months after the end of intervention.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
|
Modified Kapandji Index
Time Frame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
|
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)).
|
Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
|
JAMAR dynamometry
Time Frame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
|
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.
|
Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
|
SF-36 questionnaire
Time Frame: Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
|
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.
|
Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Anandarajah A. Erosive osteoarthritis. Discov Med. 2010 May;9(48):468-77.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 2, 2016
Primary Completion (ACTUAL)
May 1, 2017
Study Completion (ACTUAL)
February 2, 2019
Study Registration Dates
First Submitted
January 10, 2019
First Submitted That Met QC Criteria
January 14, 2019
First Posted (ACTUAL)
January 15, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 21, 2019
Last Update Submitted That Met QC Criteria
November 20, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Musculoskeletal Pain
-
Sykehuset i Vestfold HFRecruitingBack Pain | Musculoskeletal Pain | Chronic Pain | Musculoskeletal Diseases or Conditions | Pain, Chronic | Musculoskeletal Disorder | Musculoskeletal Neck PainNorway
-
University of Missouri, Kansas CityTerminatedOrthopaedic Related Pain (Musculoskeletal Pain)United States
-
Uppsala UniversityDalarna County Council, Sweden; Center for Clinical Research Dalarna, Sweden; REHSAM, SwedenTerminatedMusculoskeletal Neck Pain | Musculoskeletal Shoulder PainSweden
-
NORCE Norwegian Research Centre ASHelse Sor-Ost; Sykehuset i Vestfold HFCompletedNeck Pain Musculoskeletal | Back Pain Lower BackNorway
-
Stanford UniversityNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingPain | Joint Pain | Pain, Chronic | Chronic Musculoskeletal PainUnited States
-
University of North Carolina, Chapel HillYale University; Duke University; National Institute on Aging (NIA); Indiana University and other collaboratorsCompletedChronic Pain | Acute Musculoskeletal PainUnited States
-
Massachusetts General HospitalOrthopaedic Trauma AssociationCompleted
-
Wayne State UniversityUniversity of MichiganCompleted
-
Wayne State UniversityBlue Cross Blue Shield of Michigan FoundationCompleted
-
Wayne State UniversityUniversity of Southern CaliforniaCompleted
Clinical Trials on Magnetotherapy device
-
University of Castilla-La ManchaCentro de Salud Talavera Centro y Centro de Salud La Algodonera.; Clínica Radiodiagnóstico... and other collaboratorsCompletedPain | Knee OsteoarthritisSpain
-
The Hong Kong Polytechnic UniversityCompleted
-
Jolanta ZwolińskaCompleted
-
Jolanta ZwolińskaCompleted
-
Facet TechnologiesLifeScanCompletedDiabetesUnited States
-
Karolinska InstitutetUnknownDegenerative Disc Disease | Discogenic Low Back PainSweden
-
AOTI Ltd.UnknownDiabetic Foot UlcerUnited Kingdom, United States, Germany, France, Luxembourg
-
Cala Health, Inc.Not yet recruiting
-
International Agency for Research on CancerUniversity of North Carolina Global Project Zambia; Liger Medical LlcCompleted
-
Universitair Ziekenhuis BrusselTerminated