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Long-term effects of exercise while wearing Electrical Nerve Stimulation (TENS) for knee pain patients

Long-term effects of exercise while wearing TENS for knee pain patients - Long-term effects of exercise while wearing TENS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049305
Enrollment
100
Registered
2022-11-01
Start date
2022-11-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis(OA)

Interventions

Use of TENS during walking exercise with brief home-based exercise program and education for 6 months Just brief home-based exercise program and education for 6 months

Sponsors

Aichi Medical University
Lead Sponsor
OMRON HEALTHCARE Co., Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Knee pain for more than 3 months 2. Diagnosis of Knee osteoarthritis(OA) 3. Aged more than 40 years

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactHironori Saisu

Aichi Medical University Institute of Physical Fitness, Sports Medicine and Rehabilitation

saisu.hironori.748@mail.aichi-med-u.ac.jp0561-62-5004

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026