Clinical trial NCT04426513: Magnetotherapy in Rheumatoid Arthritis Treatment
Official title: Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Hand Rheumatism
Keywords: Magnetotherapy
Rheumatoid arthritis
Hand function
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 62
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants with rheumatoid arthritis with recommendation to physiotherapy.

Created 3 study groups:

1. Only kinesiotherapy
2. Kinesiotherapy with unipolar magnetic field
3. Kinesiotherapy with bipolar magnetic field

Kinesiotherapy with magnetic field give better effects than only kinesiotherapy.

Detailed description: Participants with rheumatoid arthritis with recommendation to physiotherapy. All participants have dysfunction and pain of hand.

Inclusion criteria:

1. II ° and III ° of advancement of radiological changes
2. II ° and III ° of advancement of functional changes
3. Remission, low or moderate RA activity: DAS28
4. Medical order

   1. Magnetotherapy and kinesiotherapy
   2. Kinesiotherapy
   3. Consent to participate in the study
   4. Completion of the research program

Exclusion criteria:

1. Additional physiotherapy treatments for the hands
2. Change in type or dose of pharmacotherapy used
3. Taking steroid anti-inflammatory drugs
4. Malaise and side effects in the subject

Outcome Measures:

1. Duration of morning stiffness
2. The degree of severity of morning stiffness
3. Pain intensity assessment (VAS)
4. Test Box \& Blocks
5. Measurement of the palmar surface of the hand
6. Measuring the range of motion in the joints of the hand
7. Measurement of compression force in a cylindrical grip
8. Time to maintain maximum pressure during cylindrical grip
9. Hand volume measurement
10. HAQ-20 test

Intervention:

1. Group 1: Only kinesiotherapy
2. Group 2: Kinesiotherapy with bipolar magnetic field
3. Group 3: Kinesiotherapy with unipolar magnetic field

Assessment:

1. Immediately before start therapy
2. Immediately after therapy (10 treatments in 2 weeks)

Eligibility criteria: Inclusion Criteria:

* II ° and III ° of advancement of radiological changes
* II ° and III ° of advancement of functional changes
* Remission, low or moderate RA activity: DAS28
* Medical order
* Magnetotherapy and kinesiotherapy
* Kinesiotherapy
* Consent to participate in the study
* Completion of the research program

Exclusion Criteria:

* Additional physiotherapy treatments for the hands
* Change in type or dose of pharmacotherapy used
* Taking steroid anti-inflammatory drugs
* Malaise and side effects in the subject

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Change from baseline VAS value immediately after therapy
measure: Health Assesment Questionaire (HAQ)
timeFrame: Change from baseline HAQ value immediately after therapy
Secondary outcomes:
measure: Test Box&Blocks
timeFrame: Change from baseline number of blocks immediately after therapy.
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: St. Hedvig Clinical Provincial Hospital No. 2, ul. Lwowska 60
state: Subcarpathian
Study officials:
References:
citation: Richmond SJ. Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis (CAMBRA): a randomised placebo-controlled crossover trial. Trials. 2008 Sep 12;9:53. doi: 10.1186/1745-6215-9-53.
citation: Zwolinska J, Gasior M, Sniezek E, Kwolek A. The use of magnetic fields in treatment of patients with rheumatoid arthritis. Review of the literature. Reumatologia. 2016;54(4):201-206. doi: 10.5114/reum.2016.62475. Epub 2016 Oct 5.
citation: Nasonov VA, Murav'ev IuV, Kuz'mina NN. [Can local therapy of joint syndrome with Dolgit cream be used as an alternative to systemic nonsteroid antiinflammatory drugs in rheumatic diseases?]. Ter Arkh. 1998;70(11):64-6. Russian.
citation: Srikesavan C, Williamson E, Cranston T, Hunter J, Adams J, Lamb SE. An Online Hand Exercise Intervention for Adults With Rheumatoid Arthritis (mySARAH): Design, Development, and Usability Testing. J Med Internet Res. 2018 Jun 27;20(6):e10457. doi: 10.2196/10457.
citation: Erol K, Gok K, Cengiz G, Ozgocmen S. Hand functions in systemic sclerosis and rheumatoid arthritis and influence on clinical variables. Int J Rheum Dis. 2018 Jan;21(1):249-252. doi: 10.1111/1756-185X.13044. Epub 2017 Mar 21.