ong-term effects of exercise while wearing Electrical Nerve Stimulation (TENS) for knee pain patients
Not Applicable
- Conditions
- Knee osteoarthritis(OA)
- Registration Number
- JPRN-UMIN000049305
- Lead Sponsor
- Aichi Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1. patients who are scheduled to have surgery during the period. 2. patients who have been exercising for more than 30 minutes at least twice a week for more than one year. 3. patients with concomitant diseases other than OA in the affected area. 4. patients with a history of surgery in the affected area. 5. Patients with pain that limits motion in areas other than the knee. 6. systemic arthritis. 7. Patients with contraindications to electrical stimulation (pacemakers, SCS, insulin pumps, etc.) 8. significant psychiatric disorders (e.g., dementia) that may interfere with participation. 9. Patients deemed by the principal investigator to be ineligible for participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time points for assessment: Pre-intervention, 1-month follow-ups, 3-month follow-ups, 6-month follow-ups Outcomes: - Knee pain Numerical Rating Scale(NRS) - Disability Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
- Secondary Outcome Measures
Name Time Method Time points for assessment: Pre-intervention, 6-month follow-ups Outcomes: - Physical activity and sedentary behavior Active Style Pro, OMRON HEALTHCARE Co., Ltd. - Quantitative Sensory Testing (QST) *Additional measurements at 3-month - Body composition and physical function Body Mass Index(BMI), 10-meter walk test, Timed up&Go test, 30s chair stand test, stand up test, 2-step test, locomo25, 12-steps stair climb test, Six minutes walk test Pain Self-efficacy Questionnaire, Pain Catastrophizing scale, Tampa Scale for Kinesiophobia, Hospital Anxiety and Depression scale, Health-related quality of life(EQ-5D), Locomo-25, Patient-perceived satisfactory improvement(6-month follow-ups), and so on. - Exercise adherence (frequency of performing each exercise by exercise-log) - Medication behavior