Rheumatoid Arthritis (RA)NCT07367438
Effect of Subthreshold Stimulation on Fatigue in Rheumatoid Arthritis
A study testing Subthreshold stimulation in people with Rheumatoid Arthritis (RA), run by Beni-Suef University.
Trial summary
The study will include 2 groups. The study group will receive subthreshold stimulation, while the control group will receive sham treatment. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Subthreshold stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
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.
The study will include 2 groups. The study group will receive subthreshold stimulation, while the control group will receive sham treatment.
Read the 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)
- Being tested
- Subthreshold stimulation, Sham treatment
- Keywords
- Subthreshold stimulation, Fatigability, lower limb strength, Inflammatory Blood Markers
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sham treatmentOther
The device will be placed on the patient without any stimulation
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | This group will receive subthreshold stimulation Receives: Device: Subthreshold stimulation |
| Control group | Sham comparator | This group will not receive any treatment Receives: Other: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (
Measured: 8 weeks
Secondary outcomes (2)
Functional disability
The investigatorswill use the Health Assessment Questionnaire to measures functional disability through patient self-reports across eight categories (dressing, arising, eating, walking, hygiene, reach, grip, activities) using a 0-3 scale (no difficulty to unable to do)
Measured: 8 weeks
Rheumatoid Arthritis Pain
The Rheumatoid Arthritis Pain Scale (RAPS) is a validated, 24-item, self-report questionnaire designed to capture the multidimensional pain experience in rheumatoid arthritis (RA) patients, assessing physiological, affective (emotional), sensory-discriminative, and cognitive aspects of pain through a single score, helping clinicians understand pain beyond just intensity for better treatment planning. Developed from pain theories, RAPS uses Likert scales, with items scored 0 (never) to 6 (always) for a total score range of 0-144, offering a comprehensive tool for assessing pain's impact and treatment effectiveness.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Mohamed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367438
- Sponsor's protocol ID
- BNS3
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07367438
- Acronym / sponsor ID
- BNS3
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Subthreshold stimulation, Fatigability, lower limb strength, Inflammatory Blood Markers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Subthreshold stimulationThis group will receive subthreshold stimulation |
| Control group | Sham comparator | Other: Sham treatmentThis group will not receive any treatment |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sixty patients with rheumatoid arthritis based on physician diagnosis and referral.
Key exclusion criteria (4 listed)
- Patients had chronic heart failure, cancer, chronic kidney disease, infection, and any other autoimmune disease (García-Morales et al., 2020).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subthreshold stimulationThe 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. | Device | Study group |
| Sham treatmentThe device will be placed on the patient without any stimulation | Other | Control group |
Primary outcome
Fatigability
Time frame: 8 weeks
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
C-reactive protein blood
Time frame: 8 weeks
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 (
2 secondary outcomes
Functional disability
Time frame: 8 weeks
Rheumatoid Arthritis Pain
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Rheumatoid Arthritis (RA)
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Not yet recruitingObservational study
The Impact of Rheumatoid Arthritis Treatments on the Modulation of Extracellular Vesicles and Other Biomarkers Involved in the Development of Lung Cancer
Rheumatoid Arthritis (RA), Lung Neoplasms
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Subthreshold stimulation in people with Rheumatoid Arthritis (RA), run by Beni-Suef University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigability (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.