UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028277 |
|---|---|
| Receipt number | 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 | 2021/02/16 14:34:49 |
* 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
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 | Kazuo |
| Middle name | |
| Last name | Hayashi |
Organization
Fukuoka Wajiro Hospital
Division name
Arthritis Center
Zip code
811-0213
Address
2-2-75 Wajirooka, Higashi-ku, Fukuoka, Japan 811-0213
TEL
+81(092)608-0001
kzo.hys.aoba.52120@gmail.com
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Hayashi |
Organization
Fukuoka Wajiro Hospital
Division name
Arthritis Center
Zip code
811-0213
Address
2-2-75 Wajirooka, Higashi-ku, Fukuoka, Japan 811-0213
TEL
+81(092)608-0001
Homepage URL
kzo.hys.aoba.52120@gmail.com
Sponsor or person
Institute
Arthritis Center,Fukuoka Wajiro Hospital
Institute
Department
Personal name
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
Fukuoka wajiro hospital
Address
2-2-75, Wajirogaoka, Higashi-ku, Fukuoka city, Japan
Tel
092-608-0001
yakuri@f-wajirohp.jp
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
196
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
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
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
| 2021 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.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 |
