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Evaluation of pain and dysfunction by using exercise prog ram and transcutaneous electrical nerve stimulation(TENS) for patients with knee osteoarthritis

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

90

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

Ninety-two participants applied for the study at the time of recruitment. Two participants were excluded based on background information and the study inclusion/exclusion criteria, and 90 participants were selected as subjects.

No adverse events were reported in this study.

Primary outcome The mean activity levels were compared between and within groups during the week before the intervention and the week before the end of the intervention. The average number of steps taken in each group was 6479.39 steps/6968.98 steps in the TENS group (pre/post intervention), 7380.46 steps/6990.05 steps in the exercise group (pre/post intervention), and 6797.30 steps/6562.17 steps in the combined group (pre/post intervention), with no significant differences between or within groups. The same results were also obtained for the duration and intensity of medium-to-high intensity activities. Secondary outcomes Secondary endpoints were evaluated in terms of gait function: 6-minute walk, TUG, and stair climbing. Among them, the mean value measured in each group for stair climbing was 4.88 sec/4.08 sec in the TENS group (pre/post intervention), 4.81 sec/4.19 sec in the exercise group (pre/post intervention), and 4.75 sec/4.07 sec in the combined group (pre/post intervention), with significant differences within each group but not between groups. No significant differences between or within groups were identified for 6-minute walk and TUG. VAS(Visual Analog Scale) was evaluated using the mean values recorded during daily activities before the intervention and one week after completion of the intervention; for JKOM, 6-minute walk, TUG, and stair climbing, the values recorded during pre- and post-intervention assessments were tabulated and compared. For VAS, the mean values were 3.91 cm/2.05 cm for the TENS group (pre-/post-intervention), 3.47 cm/2.63 cm for the exercise group (pre-/post-intervention), and 3.99 cm/2.75 cm for the combined group (pre-/post-intervention), showing significant differences within each group but not between groups. The JKOM VAS showed mean values of 4.19 cm/1.87 cm in the TENS group (pre/post intervention), 4.06 cm/3.11 cm in the exercise group (pre/post intervention), and 4.33 cm/2.80 cm in the combination group (pre/post intervention), indicating significant differences between the pre and post intervention groups except in the exercise group, but no significant differences between the groups. However, there were no significant differences between groups. For JKOM, the mean scores were 17.3 points/11.4 points in the TENS group (pre-/post-intervention), 16.15 points/12.92 points in the exercise group (pre-/post-intervention), and 20.23 points/15.64 points in the combined group (pre-/post-intervention), showing significant differences within each group but not between groups. In the HAD-A (anxiety), the mean scores were 4.75 points/3.90 pointsin the TENS group (pre/post intervention), 4.77 points/4.12 points in the exercise group (pre/post intervention), and 4.82 points/3.55 points in the combined group (pre/post intervention), with significant differences between the pre and post intervention groups except in the exercise group, but no significant differences were found between the groups. However, there were no significant differences between groups. The mean PCS was 18.05 points/13.45 points for the TENS group (pre/post intervention), 21.46 points/18.62 points for the exercise group (pre/post intervention), and 22.14 points/15.68 points for the combined group (pre/post intervention), showing significant differences before and after the intervention except for the exercise group, but no significant differences were found between the groups. However, there were no significant differences between groups.

In this study, no changes in activity level or gait function were observed. This may be due to the short intervention period. In addition, pain relief was observed before and after the intervention. In the TENS group, psychological factors may have influenced the results. Previous studies reported that pain and disability in daily life are associated with anxiety and catastrophic thinking. In this study, the TENS group showed improvement in psychological factors, suggesting similar results.

Mar. 31, 2024

No

Non

https://jrct.mhlw.go.jp/latest-detail/jRCTs052200069

Aoyama Tomoki

Graduate School of Medicine and Faculty of Medicine Kyoto University

53 Shogoin-kawaramachi, sakyo-ku,kyoto city,Kyoto Pref.

aoyama.tomoki.4e@kyoto-u.ac.jp

Yamada Keisuke

Graduate School of Medicine and Faculty of Medicine Kyoto University

53 Shogoin-kawaramachi, sakyo-ku,kyoto city,Kyoto Pref.

+81-75-751-3935

yamada.keisuke.47m@st.kyoto-u.ac.jp

Complete

Oct. 22, 2020

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

supportive care

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.

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.

Both

osteoarthritis of the knee

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.

Physical activity

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)

+81-75-753-4680

Sept. 14, 2020

none