NCT07367438

Effect of Subthreshold Stimulation on Fatigue in Rheumatoid Arthritis

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
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 electrode was placed on middle third, the third electrode was placed on distal lateral third, and the fourth electrode was placed on the distal medial third. Before applying the electrodes, the skin of the anterior thigh was cleansed with alcohol to decrease the surface impedance. The intensity of the device gradually increased till the participant started to feel the electrical current. Then, the intensity was decreased by 10%. Therefore, the intensity is about 90% of the sensation threshold.
OTHER	Sham treatment	The device will be placed on the patient without any stimulation

Timeline

• Start date: 2026-02-15
• Primary completion: 2026-05-15
• Completion: 2026-05-15
• First posted: 2026-01-26
• Last updated: 2026-01-27