Effect of Subthreshold Stimulation on Fatigue in Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Subthreshold stimulation, Sham treatment.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: 30 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Subthreshold Stimulation on Fatigability, Lower Limb Muscle Function and Strength, and Inflammatory Blood Markers in Patients With Rheumatoid Arthritis: A Randomized Controlled Study.
Overview
The study will include 2 groups. The study group will receive subthreshold stimulation, while the control group will receive sham treatment.
Detailed 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).
Interventions
- Device Subthreshold stimulation
The study group received subthreshold stimulation via a two-channel portable electrical stimulation unit (BTL-4620, Czech Republic). Two self-adhesive electrodes (9 × 5 cm Axelgaard PALS, Axelgaard Manufacturing Co. Ltd., CA, USA) were used to deliver a premixed amplitude-modulated electrical current with 100 Hz frequency/pulse 60ms width. Four electrodes were placed on the quadriceps muscle to include all the muscle as follows: the first electrode was placed on proximal third, the the secod ele - Other Sham treatment
The device will be placed on the patient without any stimulation
Primary outcome measures
- Fatigability [Time frame: 8 weeks]
- C-reactive protein blood [Time frame: 8 weeks]
Secondary outcome measures (2)
- Functional disability [Time frame: 8 weeks]
- Rheumatoid Arthritis Pain [Time frame: 8 weeks]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07367438 · BNS3