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Effect of Subthreshold Stimulation on Fatigue in Rheumatoid Arthritis

B

Beni-Suef University

Status

Begins enrollment this month

Conditions

Rheumatoid Arthritis (RA)

Treatments

Other: Sham treatment
Device: Subthreshold stimulation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The study will include 2 groups. The study group will receive subthreshold stimulation, while the control group will receive sham treatment.

Full description

This study will investigate the effect of subthreshold stimulation on fatigue-related parameters in patients with rheumatoid arthritis. This study will include 2 groups Study and the control group. The outcome measures will include Fatigability, Lower Limb Muscle Function and Strength, and Inflammatory Blood Markers. The measurements will be performed at the baseline, after 8 weeks, and after 12 weeks (follow-up).

Enrollment

84 estimated patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Sixty patients with rheumatoid arthritis based on physician diagnosis and referral.

    • The patients' ages ranged from 30 to 55 (Tedeschi et al., 2013).
    • Body mass index ranged from 25-30 kg/m2.
    • Patients diagnosed with rheumatoid arthritis 5 years ago.

Exclusion criteria

  • Patients had chronic heart failure, cancer, chronic kidney disease, infection, and any other autoimmune disease (García-Morales et al., 2020).

    • Patients had unstable ischemic heart disease or arrhythmia (Lange et al., 2019).
    • Patients had joint surgery within 6 months before inclusion which did not allow them to perform physical activity as arthroplasty (Lange et al., 2019).
    • Patients had received biologics for RA treatments (Lange et al., 2019).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

84 participants in 2 patient groups

Study group
Experimental group
Description:
This group will receive subthreshold stimulation
Treatment:
Device: Subthreshold stimulation
Control group
Sham Comparator group
Description:
This group will not receive any treatment
Treatment:
Other: Sham treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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