Rheumatoid ArthritisNCT05920746
Treatment of Rheumatoid Hand With Magnetotherapy
A study testing Kinesiotherapy with magnetotherapy in people with Rheumatoid Arthritis and Hand Rheumatism, run by Jolanta Zwolińska at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis, Hand Rheumatism
- What is being tested?
- Kinesiotherapy with magnetotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2021to 5 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Additional physiotherapy treatments for the hands
- Contraindications for magnetotherapy treatments
- Lack of informed, voluntary consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Poland1 site
Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu Rzeszowskiego
Rzeszów, Podkarpackie Voivodeship, 35-310 Rzeszów
About this study
Official title: Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Hand Rheumatism
- Being tested
- Kinesiotherapy with magnetotherapy
- Keywords
- Magnetotherapy, Rheumatoid arthritis, Hand function
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiotherapy with magnetotherapyOther
Also called Kinesiotherapy with static magnetic field, Kinesiotherapy with low-frequency pulsed magnetic field
Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 10-20 Hz, type of impulse: bipolar, rectangular pulse
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotherapy with Static Magnetic Field | Experimental | Patients have kinesiotherapy of hand and static magnetic field. All patients without steroid anti-inflammatory drugs. Receives: Other: Kinesiotherapy with magnetotherapy |
| Kinesiotherapy with low-frequency pulsed magnetic field | Experimental | Patients have kinesiotherapy of hand and low-frequency pulsed magnetic field. All patients without steroid anti-inflammatory drugs. Receives: Other: Kinesiotherapy with magnetotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline VAS value immediately after therapy.
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.
Measured: Change from baseline HAQ-20 value immediately after therapy.
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.
Measured: Change from baseline range of motion value immediately after therapy.
Displacement hand volume measurement
Measurement of hand volume using the displacement method [mm3]. The higher score means less swelling.
Measured: Change from baseline volume value immediately after therapy.
Persistence time of morning stiffness
Patient's subjective assessment of the duration of morning stiffness [min]. The longer durations means more hand dysfunction.
Measured: Change from baseline time of morning stiffness value immediately after therapy.
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.
Measured: Change from baseline time of severity of morning stiffness value immediately after therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Mar 2021
- Primary completion1 Nov 2022
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jolanta Zwolińska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jolanta Zwolińska, University of Rzeszow
- Investigators
- Jolanta Zwolinska, PhD, Principal investigator, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920746
- Sponsor's protocol ID
- Universyty of Rzeszow
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28842627Tong 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.
PubMed 35586276Chen 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.
PubMed 34210094Dundar 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.
PubMed 25955771Wu 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.
PubMed 30552258
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment
- ClinicalTrials.gov ID
- NCT05920746
- Acronym / sponsor ID
- Universyty of Rzeszow
- Conditions
- Rheumatoid Arthritis, Hand Rheumatism
- Keywords
- Magnetotherapy, Rheumatoid arthritis, Hand function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Jolanta ZwolińskaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotherapy with Static Magnetic Field | Experimental | Other: Kinesiotherapy with magnetotherapyPatients have kinesiotherapy of hand and static magnetic field. All patients without steroid anti-inflammatory drugs. |
| Kinesiotherapy with low-frequency pulsed magnetic field | Experimental | Other: Kinesiotherapy with magnetotherapyPatients have kinesiotherapy of hand and low-frequency pulsed magnetic field. All patients without steroid anti-inflammatory drugs. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Additional physiotherapy treatments for the hands
- Contraindications for magnetotherapy treatments
- Lack of informed, voluntary consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesiotherapy with magnetotherapyAlso: Kinesiotherapy with static magnetic field, Kinesiotherapy with low-frequency pulsed magnetic fieldIndividual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 10-20 Hz, type of impulse: bipolar, rectangular pulse | Other | Kinesiotherapy with Static Magnetic Field, Kinesiotherapy with low-frequency pulsed magnetic field |
Primary outcome
Visual Analogue Scale
Time frame: 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.
Health Assesment Questionaire
Time frame: 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.
Range of motion
Time frame: Change from baseline range of motion value immediately after therapy.
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
Time frame: Change from baseline volume value immediately after therapy.
Measurement of hand volume using the displacement method [mm3]. The higher score means less swelling.
Persistence time of morning stiffness
Time frame: Change from baseline time of morning stiffness value immediately after therapy.
Patient's subjective assessment of the duration of morning stiffness [min]. The longer durations means more hand dysfunction.
Severity of morning stiffness
Time frame: Change from baseline time of severity of morning stiffness value immediately after therapy.
Assessing the severity of morning stiffness using a 100-point scale. The higher score means a greater severity of morning stiffness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Background: PubMed 28842627Parate 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 publication: PubMed 35586276Tong 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 publication: PubMed 34210094Chen 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 publication: PubMed 25955771Dundar 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 publication: PubMed 30552258Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolanta Zwolinska, PhD principal investigator
University of Rzeszow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotherapy with magnetotherapy in people with Rheumatoid Arthritis and Hand Rheumatism, run by Jolanta Zwolińska at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Change from baseline VAS value immediately after therapy.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920746, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.