UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055958 |
|---|---|
| Receipt number | R000063948 |
| Scientific Title | Effects of physical therapy on sacroiliac joint dysfunction patients with shortening of psoas major muscle |
| Date of disclosure of the study information | 2024/10/29 |
| Last modified on | 2025/06/05 15:46:14 |
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Basic information
Public title
Effects of physical therapy on sacroiliac joint dysfunction patients with shortening of psoas major muscle
Acronym
Effects of physical therapy on sacroiliac joint dysfunction patients with shortening of psoas major muscle
Scientific Title
Effects of physical therapy on sacroiliac joint dysfunction patients with shortening of psoas major muscle
Scientific Title:Acronym
Effects of physical therapy on sacroiliac joint dysfunction patients with shortening of psoas major muscle
Region
| Japan |
Condition
Condition
Sacroiliac Joint dysfunction patients
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether manual intervention to the psoas major muscle improves sacroiliac joint pain in sacroiliac joint dysfunction patients with psoas major muscle shortening.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain assessment(VAS)
Key secondary outcomes
Hip flexion angle in modified Thomas test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Identify the psoas major muscle with ultrasound imaging system and perform one manual intervention on the psoas major muscle.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
sacroiliac joint dysfunction patients with rehabilitation prescription.
Positive patients for modified Thomas test.
Key exclusion criteria
Patients with remarkable neuropathy in the lower extremities.
Patients with a history of orthopedic disease of the hip joint and hip contracture.
Patients with malignant disease with bone metastases.
Patients with autoimmune diseases.
Patients unable to listen to pain due to cognitive decline.
Inappropriate patients due to other reasons.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Yamashita |
Organization
Nishinomiya municipal central hospital
Division name
Rehabilitation center
Zip code
663-8014
Address
8-24 Hayasida,Nishinomiya,Hyogo,Japan
TEL
0798-64-1515
kazukiyamasita.rpt@gmail.com
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Yamashita |
Organization
Nishinomiya municipal central hospital
Division name
Rehabilitation center
Zip code
663-8014
Address
8-24 Hayasida,Nishinomiya,Hyogo,Japan
TEL
0798-64-1515
Homepage URL
kazukiyamasita.rpt@gmail.com
Sponsor or person
Institute
Nishinomiya municipal central 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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ethics committe in Nishinomiya municipal central hospital
Address
8-24 Hayasida,Nishinomiya,Hyogo,Japan
Tel
0798-64-1515
h_iji@nishi.or.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063948
