NCT07367438

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress92%
Feb 2026May 2026

First Submitted

Initial submission to the registry

January 18, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 18, 2026

Last Update Submit

January 25, 2026

Conditions

Rheumatoid Arthritis (RA)

Keywords

Subthreshold stimulationFatigabilitylower limb strengthInflammatory Blood Markers

Outcome Measures

Primary Outcomes (2)

  • Fatigability

    Lower limb muscle performance was measured using an isokinetic dynamometer (Biodex Medical INC., Shirley, New York, USA). It was used to assess peak torque, total work, average power, work fatigue percentage, and agonist-antagonist ratio. This instrument is a gold standard, valid, objective, and reliable system used in research, clinical testing, and rehabilitation

    8 weeks

  • C-reactive protein blood

    C-reactive protein blood test is a gold standard, reliable, and valid adequate operation technique (Spasovski and Sotirova, 2014). C-reactive protein is an inexpensive and readily available biomarker to assess systemic inflammation and clinical outcomes in RA. C-reactive protein is measured from a blood sample that comes from a vein. The result is expressed in milligrams per liter (mg/L). The report might indicate that the level is high, low, or normal. Most healthy adults have CRP levels lower than 0.3 mg/L. Clinical trials often specify elevated CRP for ≥6 mg/L (

    8 weeks

Secondary Outcomes (2)

  • Functional disability

    8 weeks

  • Rheumatoid Arthritis Pain

    8 weeks

Study Arms (2)

Study group

EXPERIMENTAL

This group will receive subthreshold stimulation

Device: Subthreshold stimulation

Control group

SHAM COMPARATOR

This group will not receive any treatment

Other: Sham treatment

Interventions

Subthreshold stimulationDEVICE

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.

Study group
Sham treatmentOTHER

The device will be placed on the patient without any stimulation

Control group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 received biologics for RA treatments (Lange et al., 2019).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MSc, DPT

Study Record Dates

First Submitted

January 18, 2026

First Posted

January 26, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01