NCT04426513

Brief Summary

Participants with rheumatoid arthritis with recommendation to physiotherapy. Created 3 study groups:

  1. 1.Only kinesiotherapy
  2. 2.Kinesiotherapy with unipolar magnetic field
  3. 3.Kinesiotherapy with bipolar magnetic field

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

June 7, 2020

Last Update Submit

August 2, 2021

Conditions

Keywords

MagnetotherapyRheumatoid arthritisHand function

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Change from baseline HAQ value immediately after therapy

Secondary Outcomes (1)

  • Test Box&Blocks

    Change from baseline number of blocks immediately after therapy.

Study Arms (3)

Only kinesiotherapy

ACTIVE COMPARATOR

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

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.

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.

Other: Kinesiotherapy with magnetotherapy

Interventions

Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 0-50 Hz, type of impulse: unipolar or bipolar, rectangular pulse

Kinesiotherapy with bipolar magnetic fieldKinesiotherapy with unipolar magnetic fieldOnly kinesiotherapy

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rzeszów, Subcarpathian, 35-301, Poland

Location

Related Publications (5)

  • 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.

    PMID: 18789135BACKGROUND
  • 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.

    PMID: 27826175BACKGROUND
  • 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.

    PMID: 9949465BACKGROUND
  • 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.

    PMID: 29950288BACKGROUND
  • 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.

    PMID: 28322506BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Magnetic Field Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 11, 2020

Study Start

May 20, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

August 3, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations