UMIN-CTR Clinical Trial

Public title

Effect of Home Exercise of Quadriceps for Knee Osteoarthritis; A Randomized Con-trolled Trial comparing with Non Steroidal Anti Inflammatory Drugs

Acronym

Effect of therapeutic exercise for Knee Os-teoarthritis

Scientific Title

Effect of Home Exercise of Quadriceps for Knee Osteoarthritis; A Randomized Con-trolled Trial comparing with Non Steroidal Anti Inflammatory Drugs

Scientific Title:Acronym

Effect of therapeutic exercise for Knee Os-teoarthritis

Region

Japan

Condition

Knee Osteoarthritis

Classification by specialty

Orthopedics

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effect of home-based thera-peutic exercise for knee osteoarthritis of Japanese people.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

(1) functional assessment including ADL: WOMAC
(2) functional assessment including ADL: JKOM
(3) QOL assessment: SF-36

Key secondary outcomes

Assessment of pain: VAS

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

E1 (trial) group: Isotonic quadriceps exer-cise and frequent clinical visits.
The exercise was instructed to maintain 3-5 seconds by means of straight leg raising. Patients performed at least 4 sets consisted of 80 repetitions of the above quadriceps setting (20 times as one sets), each 2 sets in the morning and afternoon. Patients were basically instructed to do the exercise in sitting position with chair, and were also able to do in supine position if necessary.
If patients wanted heavier weight at the ex-ercise they could add 1 or 2 kg as the ankle weight gradually. One or two sets of exer-cise are imposed as check at the clinical visit.

Interventions/Control_2

C1 (Control group): Non-steriodal anti-inflammatory drugs (NSAIDs) and fre-quent clinical visits. The patients were able to stop their drugs when they no longer re-quired treatment. They were also required to record exactly how many they had been taking medicine in a note.
NSAIDs were limited only one of the three to prescribe. These were the top three used in Japan at the present; loxoprofen sodium, diclofenac sodium, and zaltoprofen.

Interventions/Control_3

E2 (trial) group: Isotonic quadriceps exer-cise and fewer clinical visits

Interventions/Control_4

C2 (Control group): NSAIDs and fewer clinical visits.

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

The patients satisfying the following condi-tions (1)-(6) are included.
(1) Outpatients aged 50-80 years old with knee pain. Both men and women are able to enter the trial.
(2) New patients for medical institution concerned, who receiving no treatment for their knee within 1 month before.
(3) Patients with the following knee symp-toms in the more symptomatic side.
Morning stiffness less than 30 minutes,
Joint crepitus
Tenderness at the joint space,
and palpable osteophytes

(4) As complications hypertension, diabetes, and hyperlipidemia under medication are allowed to enter the trial.
(5) Patient who agreed to the following ex-aminations. [X-rays]: the anteroposterior view of both knee joints in a standing posi-tion were taken and used to confirm the di-agnosis.
[Laboratory tests]: blood cell count (red blood cell, white blood cell, hemoglobin, hematocrit), biochemical examination (AST, ALT, ALP, BUN, creatinin, total cholesterol, triglyceride, uric acid), and routine urinaly-sis.
These examinations are performed once at the entry agreement time.
(6) Patient who understand aim and contents the trial and cooperate with filling the ques-tionnaire.

Key exclusion criteria

(1) Patients who had treatment for their knee at other hospital or clinic, i.e., who received therapeutic exercise, intraarticular injection, or NSAIDs within 4 weeks before the day of agreement to enter the trial
(2) Patients who had done or planned opera-tion against the knee within 6 months before or after the day of agreement to enter the trial
(3) Patients who require intra-articular in-jection
(4) Patients who take bisphosphonate, vita-min K, or hormone replacement therapy
(5) Patients who have diseases requiring regular or intermittent use of steroid or non-steroidal anti-inflammatory drugs
(6) Patients who have articular cartilage injury or history of damage due to obvious trauma or septic arthritis
(7) Patients who were diagnosed as rheu-matoid arthritis, gout, pseudogout, or colla-gen diseases
(8) Patients who had some difficulty to fill up their treatment diary
(9) Patients who had a history of cerebral vascular accident within 6 months before the day of agreement to enter the trial
(10) Patients who had a history of myocar-dial infarction within 6 months before the day of agreement to enter the trial
(11) Patients who received treatment for cardiac failure
(12) Patients with liver dysfunction
(13) Patients with renal dysfunction

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Yamamoto

Organization

The Japanese Orthopaedic Association

Division name

Chief Director

Zip code

Address

2-40-8 Hongou, Bunkyo-ku, Tokyo, JAPAN

TEL

03-3816-3671

Email

Name of contact person

1st name
Middle name
Last name	Tsutomu Iwaya

Organization

National Rehabilitation Center for Persons with Disabilities

Division name

Training Center

Zip code

Address

4-1 Namiki, Tokorozawa, Saitama, JAPAN

TEL

04-2995-3100(-2010)

Homepage URL

Email

iwaya@rehab.go.jp

Institute

The Japanese Orthopaedic Association

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

The Japanese Clinical Orthopaedic Associa-tion
The Japanese Society for Musculoskeletal Rehabilitation

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2005

Year

10

Month

27

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2003

Year

02

Month

14

Day

Date of IRB

Anticipated trial start date

2003

Year

03

Month

01

Day

Last follow-up date

2004

Year

01

Month

01

Day

Date of closure to data entry

2004

Year

12

Month

01

Day

Date trial data considered complete

2005

Year

07

Month

01

Day

Date analysis concluded

2005

Year

11

Month

01

Day

Other related information

Registered date

2005

Year

10

Month

27

Day

Last modified on

2005

Year

10

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000339