Rheumatoid ArthritisNCT04426513
Magnetotherapy in Rheumatoid Arthritis Treatment
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
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. 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
- 62 participants
- Where
- 1 sitePoland
- Study dates
- 20 May 2020to 30 Nov 2020
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
St. Hedvig Clinical Provincial Hospital No. 2, ul. Lwowska 60
Rzeszów, Subcarpathian, 35-301
About this study
Official title: Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment
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.
Read the 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)
- 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
Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 0-50 Hz, type of impulse: unipolar or bipolar, rectangular pulse
| Study group | Role | What they receive |
|---|---|---|
| Only kinesiotherapy | Active comparator | Patients have only kinesiotherapy of hand without steroid anti-inflammatory drugs and magnetotherapy. Receives: Other: Kinesiotherapy with magnetotherapy |
| Kinesiotherapy with bipolar magnetic field | Experimental | Patients have kinesiotherapy of hand and bipolar magnetic field. All patients without steroid anti-inflammatory drugs. Receives: Other: Kinesiotherapy with magnetotherapy |
| Kinesiotherapy with unipolar magnetic field | Experimental | Patients have kinesiotherapy of hand and unipolar 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 (VAS)
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 (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.
Measured: Change from baseline HAQ value immediately after therapy
Secondary outcomes (1)
Test Box&Blocks
Objective assessment of level of disability of hand. Number of blocks transfer from box 1 to box 2 during 1 minute.
Measured: Change from baseline number of blocks 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 posted11 Jun 2020
- Study start20 May 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jolanta Zwolińska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jolanta Zwolińska, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426513
- Sponsor's protocol ID
- Magnetotherapy/ RA
- Status last verified
- Aug 2021
- First submitted
- 7 Jun 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18789135Zwolinska 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.
PubMed 27826175Nasonov 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.
PubMed 9949465Srikesavan 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.
PubMed 29950288Erol 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.
PubMed 28322506
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. 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
- NCT04426513
- Acronym / sponsor ID
- Magnetotherapy/ RA
- Conditions
- Rheumatoid Arthritis, Hand Rheumatism
- Keywords
- Magnetotherapy, Rheumatoid arthritis, Hand function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Jolanta ZwolińskaUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 11 Jun 2020 (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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Only kinesiotherapy | Active comparator | Other: Kinesiotherapy with magnetotherapyPatients have only kinesiotherapy of hand without steroid anti-inflammatory drugs and magnetotherapy. |
| Kinesiotherapy with bipolar magnetic field | Experimental | Other: Kinesiotherapy with magnetotherapyPatients have kinesiotherapy of hand and bipolar magnetic field. All patients without steroid anti-inflammatory drugs. |
| Kinesiotherapy with unipolar magnetic field | Experimental | Other: Kinesiotherapy with magnetotherapyPatients have kinesiotherapy of hand and unipolar 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 (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 magnetotherapyIndividual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 0-50 Hz, type of impulse: unipolar or bipolar, rectangular pulse | Other | Kinesiotherapy with bipolar magnetic field, Kinesiotherapy with unipolar magnetic field, Only kinesiotherapy |
Primary outcome
Visual Analogue Scale (VAS)
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 (HAQ)
Time frame: Change from baseline HAQ 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.
1 secondary outcome
Test Box&Blocks
Time frame: Change from baseline number of blocks immediately after therapy.
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 3 Aug 2021.
- Background: PubMed 18789135Richmond 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.
- Background: PubMed 27826175Zwolinska 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.
- Background: PubMed 9949465Nasonov 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.
- Background: PubMed 29950288Srikesavan 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.
- Background: PubMed 28322506Erol 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 8 inclusion and 4 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 3 Aug 2021. 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 (VAS) (time frame: Change from baseline VAS value immediately after therapy). The study lists 2 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 NCT04426513, 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 3 Aug 2021.