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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028277
Receipt No. R000032328
Scientific Title Investigation regarding effects of PSTR(Pericapsular soft tissue and realignment) exercises to improve function in patients with osteoarthritis of the hip and a Harris Hip Score(HHS) below 60 points
Date of disclosure of the study information 2017/07/20
Last modified on 2019/01/06

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Basic information
Public title Investigation regarding effects of PSTR(Pericapsular soft tissue and realignment) exercises to improve function in patients with osteoarthritis of the hip and a Harris Hip Score(HHS) below 60 points
Acronym Investigation of PSTR exercises
in patients with osteoarthritis of the hip and an HHS below 60 points
Scientific Title Investigation regarding effects of PSTR(Pericapsular soft tissue and realignment) exercises to improve function in patients with osteoarthritis of the hip and a Harris Hip Score(HHS) below 60 points
Scientific Title:Acronym Investigation of PSTR exercises
in patients with osteoarthritis of the hip and an HHS below 60 points
Region
Japan

Condition
Condition Osteoarthritis of the Hip
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of exercise for prevention or postpone of surgery in patients with osteoarthritis of the hip
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HHS(Harris Hip Score)
Key secondary outcomes SF-36v2,JOA Score,NRS,ROM,the opening angle of the hip according to a modified Patrick's test,the maximum strength of hip abductors,TUG test,One Leg Standing Time,K/L grade,MJS,OA questionnaire check list,the ratio of cases in which exercises can be continued after 3 months from the baseline,the ratio of cases in which PSTR exercises were done for 6 months from the baseline,the ratio of cases with improvement of HHS above 10 points

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Patient education and PSTR exercise
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients who wish to prevent surgery
2)Patients with 18-85 years at
consent
3)Patients with hip pain for more than 3 months
4)Patients eligible for more than 2 of the following 1-3 criteria(ACR : American College of Rheumatology criteria) or 4.
1:ESR<20mm/h i)
2:osteophytes(femoral or acetabular)
3:joint space narrowing
4:hip pain due to acetabular dysplasia
5)Patients in which the difference in the height of the tip of the greater trochanter was 2.0 cm or less on standing full-length radiographs of the lower extremities
6)Patients with an HHS below 60 points
7)Patients with consent by documents for the participation in this study
i)Patients who are not eligible for 4 item and eligible for only one item of 2 or 3 in 4) should be confirmed about
Key exclusion criteria 1)Patients who undergo the treatment of cardiovascular diseases
2)Patients who undergo the treatment of cancer
3) Patients who have severe osteoporosis/dysfunction in the lower extremities due to an accident or disease besides OA of the hip(e.g. osteoarthritis with the knee above K/L grade 2)
4)Patients with pregnancy
5) All kinds of surgeries of the lower extremities
6) Patients who undergo the instruction of PSTR exercises by therapists within one year (patients who performed exercises by themselves according to the instruction of the book are not excluded.)
7)Patients with dementia who seem to be not eligible for exercises(Doctor's judgement ; e.g. patients who have difficulty with writing the diary or understanding exercises)
8)Patients with osteonecrosis of the femoral head
9)Patients with a subchondral insufficiency fracture (SIF) of the femoral head
10) Patients with Perthes disease
11)Patients with rheumatoid arthritis
12) Patients with infection
13)Patients in which malignant diseases are suspected at the hip joints or around the hip
14) Other patients in which doctor considered that they were not eligible
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hayashi Kazuo
Organization Fukuoka Wajiro Hospital
Division name Arthritis Center
Zip code
Address 2-2-75 Wajirooka, Higashi-ku, Fukuoka, Japan 811-0213
TEL +81(092)608-0001
Email hayashis@giga.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hayashi Kazuo
Organization Fukuoka Wajiro Hospital
Division name Arthritis Center
Zip code
Address 2-2-75 Wajirooka, Higashi-ku, Fukuoka, Japan 811-0213
TEL +81(092)608-0001
Homepage URL
Email hayashis@giga.ocn.ne.jp

Sponsor
Institute Arthritis Center,Fukuoka Wajiro Hospital
Institute
Department

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

Other related organizations
Co-sponsor Department of Orthopaedics, Asama General Hospital
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 福岡和白病院(福岡市)
浅間総合病院(長野県)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 19 Day
Last modified on
2019 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032328

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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