Treatment of Rheumatoid Hand With Magnetotherapy

• Sponsor: Jolanta Zwolińska (Other)
• Overall Status: Completed
• CT.gov ID: NCT05920746
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.2
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

Brief Summary:

Participants with rheumatoid arthritis with recommendation to physiotherapy.

Created 2 study groups:

1. Kinesiotherapy with static magnetic field

2. Kinesiotherapy with low-frequency pulsed magnetic field

Pulsed magnetic field give better effects then static magnetic field.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis; Hand Rheumatism	Other: Kinesiotherapy with magnetotherapy	N/A

Detailed Description

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

Inclusion criteria:

1. Informed voluntary consent to participate in the study

2. II ° and III ° of advancement of radiological changes

3. II ° and III ° of advancement of functional changes

4. Remission, low or moderate RA activity: DAS28

5. Medical referral for physiotherapy treatment

Exclusion criteria:

1. Additional physiotherapy treatments for the hands

2. Contraindications for magnetotherapy treatments

3. Lack of informed, voluntary consent to participate in the study

Outcome Measures:

1. Duration of morning stiffness

2. The degree of severity of morning stiffness

3. Pain intensity assessment (VAS)

4. Measuring the range of motion in the joints of the hand

5. Hand volume measurement

6. HAQ-20 test

Intervention:

1. Group "S": Kinesiotherapy with static magnetic field

2. Group "P": Kinesiotherapy with low-frequency pulsed magnetic field

Assessment:

1. Immediately before start therapy

2. Immediately after therapy (10 treatments in 3 weeks)

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Assessor evaluating the patients' condition had no knowledge of the outcome of randomization of patients to the study groups.
• Primary Purpose: Treatment
• Official Title: Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Nov 1, 2022
• Actual Study Completion Date: Jan 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kinesiotherapy with Static Magnetic Field Patients have kinesiotherapy of hand and static magnetic field. All patients without steroid anti-inflammatory drugs.	Other: Kinesiotherapy with magnetotherapy; Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 10-20 Hz, type of impulse: bipolar, rectangular pulse; Other Names: Kinesiotherapy with static magnetic field Kinesiotherapy with low-frequency pulsed magnetic field
Experimental: Kinesiotherapy with low-frequency pulsed magnetic field Patients have kinesiotherapy of hand and low-frequency pulsed magnetic field. All patients without steroid anti-inflammatory drugs.	Other: Kinesiotherapy with magnetotherapy; Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 10-20 Hz, type of impulse: bipolar, rectangular pulse; Other Names: Kinesiotherapy with static magnetic field Kinesiotherapy with low-frequency pulsed magnetic field

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scale (VAS) [Change from baseline VAS value immediately after therapy.]

   Pain severity rating scale. only one value. Minimum value is 0, maximum value is 10. The best is 0, the worst is 10.

2. Health Assesment Questionaire (HAQ-20) [Change from baseline HAQ-20 value immediately after therapy.]

   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

3. Range of motion [Change from baseline range of motion value immediately after therapy.]

   Computerized measurement of the range of motion of the joints of the hand [mm].

4. Displacement hand volume measurement [Change from baseline volume value immediately after therapy.]

   Measurement of hand volume using the displacement method [mm3].

5. Persistence time of morning stiffness [Change from baseline time of morning stiffness value immediately after therapy.]

   Patient's subjective assessment of the duration of morning stiffness [min].

6. Severity of morning stiffness [Change from baseline time of severity of morning stiffness value immediately after therapy.]

   Assessing the severity of morning stiffness using a 100-point scale.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Informed voluntary consent to participate in the study

2. II ° and III ° of advancement of radiological changes

3. II ° and III ° of advancement of functional changes

4. Remission, low or moderate RA activity: DAS28

5. Medical referral for physiotherapy treatment

Exclusion Criteria:

1. Additional physiotherapy treatments for the hands

2. Contraindications for magnetotherapy treatments

3. Lack of informed, voluntary consent to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu Rzeszowskiego	Rzeszów	Podkarpackie	Poland	35-310 Rzeszów

Sponsors and Collaborators

• Jolanta Zwolińska

Investigators

• Principal Investigator: Jolanta Zwolinska, PhD, University of Rzeszow

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Jolanta Zwolińska, PhD, University of Rzeszow
• ClinicalTrials.gov Identifier: NCT05920746
• Other Study ID Numbers: Universyty of Rzeszow
• First Posted: Jun 27, 2023
• Last Update Posted: Jun 27, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jolanta Zwolińska, PhD, University of Rzeszow: Magnetotherapy; Rheumatoid arthritis; Hand function
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Rheumatic Diseases

Study Results

No Results Posted as of Jun 27, 2023