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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Beni-Suef University
- Enrollment
- 84
- Primary Endpoint
- Fatigability
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/m
- •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).
Arms & Interventions
Study group
This group will receive subthreshold stimulation
Intervention: Subthreshold stimulation (Device)
Control group
This group will not receive any treatment
Intervention: Sham treatment (Other)
Outcomes
Primary Outcomes
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 (
Secondary Outcomes
- Functional disability(8 weeks)
- Rheumatoid Arthritis Pain(8 weeks)
Investigators
Ayman Mohamed
PhD, MSc, DPT
Beni-Suef University