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Magnetotherapy in Rheumatoid Arthritis Treatment

Primary Purpose

Rheumatoid Arthritis, Hand Rheumatism

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Kinesiotherapy with magnetotherapy
Sponsored by
Jolanta Zwolińska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Magnetotherapy, Rheumatoid arthritis, Hand function

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Hedvig Clinical Provincial Hospital No. 2, ul. Lwowska 60

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Only kinesiotherapy

Kinesiotherapy with bipolar magnetic field

Kinesiotherapy with unipolar magnetic field

Arm Description

Patients have only kinesiotherapy of hand without steroid anti-inflammatory drugs and magnetotherapy.

Patients have kinesiotherapy of hand and bipolar magnetic field. All patients without steroid anti-inflammatory drugs.

Patients have kinesiotherapy of hand and unipolar magnetic field. All patients without steroid anti-inflammatory drugs.

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS)
Pain severity rating scale. only one value. Minimum value is 0, maximum value is 10. The best is 0, the worst is 10.
Health Assesment Questionaire (HAQ)
Subjective assesment of level of disability. Value of each of 8 subsections: minimum value 0, maximum value 3. total score is averaged. The best total score is 0, the worst is 3.

Secondary Outcome Measures

Test Box&Blocks
Objective assessment of level of disability of hand. Number of blocks transfer from box 1 to box 2 during 1 minute.

Full Information

First Posted
June 7, 2020
Last Updated
August 2, 2021
Sponsor
Jolanta Zwolińska
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1. Study Identification

Unique Protocol Identification Number
NCT04426513
Brief Title
Magnetotherapy in Rheumatoid Arthritis Treatment
Official Title
Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jolanta Zwolińska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Participants with rheumatoid arthritis with recommendation to physiotherapy. Created 3 study groups: Only kinesiotherapy Kinesiotherapy with unipolar magnetic field 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: 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 Outcome Measures: Duration of morning stiffness The degree of severity of morning stiffness Pain intensity assessment (VAS) Test Box & Blocks Measurement of the palmar surface of the hand Measuring the range of motion in the joints of the hand Measurement of compression force in a cylindrical grip Time to maintain maximum pressure during cylindrical grip Hand volume measurement HAQ-20 test Intervention: Group 1: Only kinesiotherapy Group 2: Kinesiotherapy with bipolar magnetic field Group 3: Kinesiotherapy with unipolar magnetic field Assessment: Immediately before start therapy Immediately after therapy (10 treatments in 2 weeks)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Hand Rheumatism
Keywords
Magnetotherapy, Rheumatoid arthritis, Hand function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Only kinesiotherapy
Arm Type
Active Comparator
Arm Description
Patients have only kinesiotherapy of hand without steroid anti-inflammatory drugs and magnetotherapy.
Arm Title
Kinesiotherapy with bipolar magnetic field
Arm Type
Experimental
Arm Description
Patients have kinesiotherapy of hand and bipolar magnetic field. All patients without steroid anti-inflammatory drugs.
Arm Title
Kinesiotherapy with unipolar magnetic field
Arm Type
Experimental
Arm Description
Patients have kinesiotherapy of hand and unipolar magnetic field. All patients without steroid anti-inflammatory drugs.
Intervention Type
Other
Intervention Name(s)
Kinesiotherapy with magnetotherapy
Intervention Description
Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 0-50 Hz, type of impulse: unipolar or bipolar, rectangular pulse
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
Pain severity rating scale. only one value. Minimum value is 0, maximum value is 10. The best is 0, the worst is 10.
Time Frame
Change from baseline VAS value immediately after therapy
Title
Health Assesment Questionaire (HAQ)
Description
Subjective assesment of level of disability. Value of each of 8 subsections: minimum value 0, maximum value 3. total score is averaged. The best total score is 0, the worst is 3.
Time Frame
Change from baseline HAQ value immediately after therapy
Secondary Outcome Measure Information:
Title
Test Box&Blocks
Description
Objective assessment of level of disability of hand. Number of blocks transfer from box 1 to box 2 during 1 minute.
Time Frame
Change from baseline number of blocks immediately after therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
St. Hedvig Clinical Provincial Hospital No. 2, ul. Lwowska 60
City
Rzeszów
State/Province
Subcarpathian
ZIP/Postal Code
35-301
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18789135
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.
Results Reference
background
PubMed Identifier
27826175
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.
Results Reference
background
PubMed Identifier
9949465
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.
Results Reference
background
PubMed Identifier
29950288
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.
Results Reference
background
PubMed Identifier
28322506
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.
Results Reference
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Magnetotherapy in Rheumatoid Arthritis Treatment

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