UMIN-CTR Clinical Trial

Public title

Exercise therapy of the healthy side for pain after total knee arthroplasty

Acronym

Exercise therapy of the healthy side for pain after total knee arthroplasty

Scientific Title

Analgesic effects of exercise therapy of the healthy side during range of motion training after total knee arthroplasty

Scientific Title:Acronym

Analgesic effects of exercise therapy of the healthy side during range of motion training after total knee arthroplasty

Region

Japan

Condition

Osteoarthritis of the knee

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Postoperative rehabilitation is important for early recovery and early return to society, but postoperative rehabilitation is often accompanied by pain. On the other hand, it is known that exercise therapy activates the endogenous pain inhibitory system and alleviates musculoskeletal pain.
In rehabilitation after knee replacement surgery, a continuous passive motion (CPM) device is used to gain range of motion of the knee. Although CPM is usually performed only on the operated side, it is expected that CPM can activate the endogenous pain inhibitory system by exercise therapy on the healthy side. In addition, we believe that CPM is effective in reacquiring the body image of the operated side, whose depth perception is diminished or lost after knee replacement. In this study, we will examine the pain-relieving effects of exercising the healthy side during postoperative range-of-motion training using CPM.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Visual Analog Scale and knee joint range of motion before and after CPM on postoperative days 2, 4, 7, and 14.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

The usual treatment group applies CPM devise to the operated side for a range of motion training.

Interventions/Control_2

The intervention group also applies CPM devise to the non-operated knee and performs a range of motion training in sync with the operated side.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

60

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients who underwent unilateral total knee arthroplasty in our hospital and consented to this study.

Key exclusion criteria

Patients with diabetes and/or rheumatoid arthritis. Patients who were unable to give consent for this study.

Target sample size

80

Name of lead principal investigator

1st name	Motoki
Middle name
Last name	Sonohata

Organization

Saga University

Division name

Department of Orthopaedic Surgery, Faculty of Medicine

Zip code

849-8501

Address

5-1-1 Nabeshima, Saga city, Saga, Japan.

TEL

0952-34-2343

Email

sonohata@cc.saga-u.ac.jp

Name of contact person

1st name	Shuichi
Middle name
Last name	Eto

Organization

Saga university

Division name

Department of Orthopaedic Surgery, Faculty of Medicine

Zip code

849-8501

Address

5-1-1 Nabeshima, Saga city, Saga, Japan.

TEL

0952-34-2343

Homepage URL

Email

sagaseikei@gmail.com

Institute

Saga university

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical research center, Saga university hospital

Address

5-1-1 Nabeshima, Saga city, Saga, Japan.

Tel

0952-34-3400

Email

kenkyu-shinsei@ml.cc.saga-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

09

Month

15

Day

URL releasing protocol

https://www.hindawi.com/journals/prm/2023/1613116/?utm_medium=author&utm_source=Hindawi

Publication of results

Published

URL related to results and publications

https://www.hindawi.com/journals/prm/2023/1613116/?utm_medium=author&utm_source=Hindawi

Number of participants that the trial has enrolled

40

Results

Comparison of VAS scores before and after CPM showed no significant intergroup differences on all measurement dates. However, there was a significant difference in values on day 14 (P<0.05). Both groups showed an increase in ROM after CPM, with significant increments observed on days 2 and 4 in the bilateral group and on day 14 in the unilateral group. There was no significant difference in values on postoperative day 14.

Results date posted

2023

Year

04

Month

13

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

We enrolled patients aged >60 years who were scheduled for unilateral TKA at the university hospital. Patients were excluded based on the following criteria: severe pain or deformity of the knee on the contralateral side; chronic opioid use; diabetes mellitus; rheumatoid arthritis; necessity of anticoagulants; or impairment of cognitive function.

Participant flow

This study was conducted as a prospective randomized controlled trial. Participants were randomly assigned to two groups: a bilateral group that performed bilateral exercise on the affected and healthy sides, and a unilateral group that performed exercise therapy only on the affected side. Computer-generated block randomization (block size, 4, revealed to the study group at the first exercise) was used for randomization such that both groups contained equal numbers of patients. Group allocation was performed by the first author; the examiner and patients were blinded to group assignment until the CPM practice began. As the groups performed different CPM practices, the participants could not be masked to the group assignment.

Adverse events

No adverse events were noted.

Outcome measures

The following patient information was collected preoperatively: age, sex, body mass index (BMI), diagnosis, Visual analogue scale (VAS) score, knee joint ROM, and Kellgren-Lawrence
classification for the operated and non-operated sides. For postoperative evaluation, the time from return to first use of rescue analgesia and the total amount of rescue analgesia during the study period were also measured. VAS scores and ROM on the operated side were measured immediately before and after CPM on postoperative days 2, 4, 7, and 14. The
10-m walk test was performed on postoperative days 7 and 14 to evaluate walking ability, The primary outcome was the difference in the VAS scores before and after CPM on postoperative day 14. The secondary outcome was the difference in the ROM before and after CPM and the 10-m walk test result on postoperative day 14.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2019

Year

07

Month

01

Day

Date of IRB

2019

Year

07

Month

01

Day

Anticipated trial start date

2019

Year

07

Month

01

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

09

Month

09

Day

Last modified on

2023

Year

06

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048173