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Treatment of Rheumatoid Hand With Magnetotherapy

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: Informed voluntary consent to participate in the study II ° and III ° of advancement of radiological changes II ° and III ° of advancement of functional changes Remission, low or moderate RA activity: DAS28 Medical referral for physiotherapy treatment Exclusion Criteria: Additional physiotherapy treatments for the hands Contraindications for magnetotherapy treatments Lack of informed, voluntary consent to participate in the study

Sites / Locations

  • Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu Rzeszowskiego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Kinesiotherapy with Static Magnetic Field

Kinesiotherapy with low-frequency pulsed magnetic field

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual Analogue Scale
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
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.
Range of motion
Computerized measurement of the range of motion of the joints of the hand [mm]. A higher score value meant a greater range of motions.
Displacement hand volume measurement
Measurement of hand volume using the displacement method [mm3]. The higher score means less swelling.
Persistence time of morning stiffness
Patient's subjective assessment of the duration of morning stiffness [min]. The longer durations means more hand dysfunction.
Severity of morning stiffness
Assessing the severity of morning stiffness using a 100-point scale. The higher score means a greater severity of morning stiffness.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2023
Last Updated
July 6, 2023
Sponsor
Jolanta Zwolińska
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1. Study Identification

Unique Protocol Identification Number
NCT05920746
Brief Title
Treatment of Rheumatoid Hand With Magnetotherapy
Official Title
Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
January 5, 2023 (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
Brief Summary: Participants with rheumatoid arthritis with recommendation to physiotherapy. Created 2 study groups: Kinesiotherapy with static magnetic field Kinesiotherapy with low-frequency pulsed magnetic field Pulsed magnetic field give better effects then static magnetic field.
Detailed Description
Participants with rheumatoid arthritis with recommendation to physiotherapy. All participants have dysfunction and pain of hand. Before entering the study, all patients were examined by a rheumatologist, who determined the degree of radiological and functional changes and measured blood pressure. Patients with II° and III° of radiological and functional changes were qualified for the study. All the patients gave their informed consent to participate in the study. The examination included an overall assessment of functional status. Patients were examined immediately before and after the intervention.

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
Masking Description
Assessor evaluating the patients' condition had no knowledge of the outcome of randomization of patients to the study groups.
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotherapy with Static Magnetic Field
Arm Type
Experimental
Arm Description
Patients have kinesiotherapy of hand and static magnetic field. All patients without steroid anti-inflammatory drugs.
Arm Title
Kinesiotherapy with low-frequency pulsed magnetic field
Arm Type
Experimental
Arm Description
Patients have kinesiotherapy of hand and low-frequency pulsed magnetic field. All patients without steroid anti-inflammatory drugs.
Intervention Type
Other
Intervention Name(s)
Kinesiotherapy with magnetotherapy
Other Intervention Name(s)
Kinesiotherapy with static magnetic field, Kinesiotherapy with low-frequency pulsed magnetic field
Intervention Description
Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 10-20 Hz, type of impulse: bipolar, rectangular pulse
Primary Outcome Measure Information:
Title
Visual Analogue Scale
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
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-20 value immediately after therapy.
Title
Range of motion
Description
Computerized measurement of the range of motion of the joints of the hand [mm]. A higher score value meant a greater range of motions.
Time Frame
Change from baseline range of motion value immediately after therapy.
Title
Displacement hand volume measurement
Description
Measurement of hand volume using the displacement method [mm3]. The higher score means less swelling.
Time Frame
Change from baseline volume value immediately after therapy.
Title
Persistence time of morning stiffness
Description
Patient's subjective assessment of the duration of morning stiffness [min]. The longer durations means more hand dysfunction.
Time Frame
Change from baseline time of morning stiffness value immediately after therapy.
Title
Severity of morning stiffness
Description
Assessing the severity of morning stiffness using a 100-point scale. The higher score means a greater severity of morning stiffness.
Time Frame
Change from baseline time of severity of morning stiffness value 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: Informed voluntary consent to participate in the study II ° and III ° of advancement of radiological changes II ° and III ° of advancement of functional changes Remission, low or moderate RA activity: DAS28 Medical referral for physiotherapy treatment Exclusion Criteria: Additional physiotherapy treatments for the hands Contraindications for magnetotherapy treatments Lack of informed, voluntary consent to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jolanta Zwolinska, PhD
Organizational Affiliation
University of Rzeszow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu Rzeszowskiego
City
Rzeszów
State/Province
Podkarpackie
ZIP/Postal Code
35-310 Rzeszów
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28842627
Citation
Parate D, Franco-Obregon A, Frohlich J, Beyer C, Abbas AA, Kamarul T, Hui JHP, Yang Z. Enhancement of mesenchymal stem cell chondrogenesis with short-term low intensity pulsed electromagnetic fields. Sci Rep. 2017 Aug 25;7(1):9421. doi: 10.1038/s41598-017-09892-w.
Results Reference
background
PubMed Identifier
35586276
Citation
Tong J, Chen Z, Sun G, Zhou J, Zeng Y, Zhong P, Deng C, Chen X, Liu L, Wang S, Chen J, Liao Y. The Efficacy of Pulsed Electromagnetic Fields on Pain, Stiffness, and Physical Function in Osteoarthritis: A Systematic Review and Meta-Analysis. Pain Res Manag. 2022 May 9;2022:9939891. doi: 10.1155/2022/9939891. eCollection 2022.
Results Reference
result
PubMed Identifier
34210094
Citation
Chen Y, Aspera-Werz RH, Menger MM, Falldorf K, Ronniger M, Stacke C, Histing T, Nussler AK, Ehnert S. Exposure to 16 Hz Pulsed Electromagnetic Fields Protect the Structural Integrity of Primary Cilia and Associated TGF-beta Signaling in Osteoprogenitor Cells Harmed by Cigarette Smoke. Int J Mol Sci. 2021 Jun 29;22(13):7036. doi: 10.3390/ijms22137036.
Results Reference
result
PubMed Identifier
25955771
Citation
Dundar U, Asik G, Ulasli AM, Sinici S, Yaman F, Solak O, Toktas H, Eroglu S. Assessment of pulsed electromagnetic field therapy with Serum YKL-40 and ultrasonography in patients with knee osteoarthritis. Int J Rheum Dis. 2016 Mar;19(3):287-93. doi: 10.1111/1756-185X.12565. Epub 2015 May 8.
Results Reference
result
PubMed Identifier
30552258
Citation
Wu Z, Ding X, Lei G, Zeng C, Wei J, Li J, Li H, Yang T, Cui Y, Xiong Y, Wang Y, Xie D. Efficacy and safety of the pulsed electromagnetic field in osteoarthritis: a meta-analysis. BMJ Open. 2018 Dec 14;8(12):e022879. doi: 10.1136/bmjopen-2018-022879.
Results Reference
result

Learn more about this trial

Treatment of Rheumatoid Hand With Magnetotherapy

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