UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000268
Receipt No. R000000339
Scientific Title Effect of Home Exercise of Quadriceps for Knee Osteoarthritis; A Randomized Con-trolled Trial comparing with Non Steroidal Anti Inflammatory Drugs
Date of disclosure of the study information 2005/10/27
Last modified on 2005/10/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition Knee Osteoarthritis
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute The Japanese Orthopaedic Association
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor The Japanese Clinical Orthopaedic Associa-tion
The Japanese Society for Musculoskeletal Rehabilitation
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 10 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2005 Year 10 Month 27 Day
Last modified on
2005 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000339

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.