UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study for Low-Intensity Pulsed Ultrasound Effects on Patients with Lumbar Spondylolysis
Title of the study (Brief title)	A Study for Low-Intensity Pulsed Ultrasound Effects on Patients with Lumbar Spondylolysis
Region	Japan

Condition
Condition	Lumbar Spondylolysis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the treatment effect and safety of low-intensity pulsed ultrasound on patients with lumbar spondylolysis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bony fusion rate, Duration of the treatment period, Complications
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Low-intensity pulsed ultrasound
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	5 years-old <=
Age-upper limit	50 years-old >=
Gender	Male and Female
Key inclusion criteria	Progressive-stage spondylolysis at the first presentation, Non-union after surgery at 6 months' follow-up.
Key exclusion criteria	Patients obtained with no agreement, patients who do not continue the treatment.
Target sample size	70

Research contact person
Name of lead principal investigator	Koichi Sairyo
Organization	Tokushima University Hospital
Division name	Department of Orthopaedic Surgery
Address	Kuramoto 3-18-15, Tokushima city
TEL	0886337240
Email	sairyokun@gmail.com

Public contact
Name of contact person	Toshinori Sakai
Organization	Tokushima University
Division name	Department of Orthopaedic Surgery
Address	Kuramoto 3-18-15, Tokushima city
TEL	0886337240
Homepage URL
Email	norinori@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

Funding Source
Organization	Nippon Sigmax Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 11 Month 01 Day
Anticipated trial start date	2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 21 Day
Last modified on	2017 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033412