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Completed

NCT Number: NCT04426513

Magnetotherapy in Rheumatoid Arthritis Treatment

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Hand Rheumatism Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Rzeszów, Subcarpathian, 35-301, Poland

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinesiotherapy with magnetotherapy

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Test Box&Blocks

    Time frame: Change from baseline number of blocks immediately after therapy.

    Objective assessment of level of disability of hand. Number of blocks transfer from box 1 to box 2 during 1 minute.

Sponsors and collaborators

Lead sponsor

Jolanta Zwolińska

Other

Registry information

Official study title

Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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