Pain relief evaluation using transcutaneous electrical nerve stimulation(TENS) and exercise therapy for osteoarthritis of the knee

JRCT ID: jRCTs052200069

Registered date:22/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: osteoarthritis of the knee
• Date of first enrollment: 31/10/2022
• Target sample size: 90
• Study type: Interventional

Intervention(s)

TENS Group
TENS g roup participants wore the TENS device under the patella of the symptomatic knee.
The intensity in the TENS group is g radually increase and limiteby the participants perception of a strong
but comfortable.

Exercise group
Check the condition of knee pain using a questionnaire, and perform exercise items determined from the pain area and condition.

Combination group
Implement both interventions.

Outcome(s)

• Primary Outcome: Physical activity

Secondary Outcome

stair climb test
6-minute walk test
Time Up and Go test
knee pain evaluated using the VAS
Standup Test
Two-Step Test
Evaluation of psycholog ical state using questionn
aire(HADS,PCS)

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Confirmed knee osteoarthritis by X-ray examination.
Pain that began minimum of 3-months ago before the onset of pain.
Male or Female between the ages of 50 years or older.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Exclude criteria

Patients had a history of knee surgery.
Patients had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months prior to
enrollment.
Patients were undergoing physical therapy.
Patients had any other major joint pain (e.g., back, hip, or ankle).
Patients had contraindications to TENS(pacemakers, dermatological conditions, and abnormal sensation in
the knees).
Patients had severe medical conditions (arteriosclerosis obliterans, malignant neoplasms, myocardial
infarction) or neurological disorders (stroke, spinal cord injury, neurodegenerative disease, peripheral
neuropathy due to severe diabetes).
Inappropriate to enter this trial judged by the physician in charge.

Related Information

• Primary Sponsor: Aoyama Tomoki
• Source(s) of Monetary Support: OMRON HEALTHCARE Co., Ltd.