UMIN-CTR Clinical Trial

Basic information
Public title	Estimating the intangible cost of intradiscal enzyme injection therapy and surgery for lumbar disc herniation based on therapeutic characteristics
Acronym	Estimating the intangible cost of intradiscal enzyme injection therapy and surgery for lumbar disc herniation based on therapeutic characteristics
Scientific Title	Estimating the intangible cost of intradiscal enzyme injection therapy and surgery for lumbar disc herniation based on therapeutic characteristics
Scientific Title:Acronym	Estimating the intangible cost of intradiscal enzyme injection therapy and surgery for lumbar disc herniation based on therapeutic characteristics
Region	Japan

Condition
Condition	lumbar disc herniation
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the intangible cost based on the therapeutic characteristics of intradiscal enzyme injection therapy and surgical therapy for lumbar disc herniation.
Basic objectives2	Others
Basic objectives -Others	When choosing treatment for lumbar disc herniation, in addition to medical costs and productivity loss, the value of treatment characteristics for patients, such as wound size, duration of post-treatment pain, and anesthesia method, also affect treatment choice. In this study, we focus on the patient's decision making and estimate the intangible cost of disc enzyme injection therapy and surgery based on the treatment characteristics by conjoint analysis using a questionnaire for the general public and patients who have experienced lumbar disc herniation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Six attributes are used in the conjoint analysis: wound size, duration of pain associated with treatment, degree of pain associated with treatment, anesthesia method, response rate, and out-of-pocket costs, and each of these intangible cost is calculated.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	(1) General public: 400 people will be randomly selected from among the men and women aged 20-69 in the panel, according to the national distribution. (2) People who have experienced invasive treatment of hernia: 100 people who have experienced invasive treatment of hernia will be selected out of all the people in the panel with no age restriction. (3) Other experienced hernia patients: 300 experienced hernia patients who had no experience of invasive treatment will be selected from all the people in the panel with no age restriction. Invasive treatment is defined here as enzyme infusion therapy or endoscopic surgery or direct vision surgery.
Key exclusion criteria	Medical professionals, advertising agencies, research agency personnel and their families
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Shu Middle name Last name Takaki
Organization	KAKEN PHARMACEUTICAL CO.,LTD.
Division name	Medical Affairs Department
Zip code	113-8650
Address	2-28-8, Honkomagome, Bunkyo-ku, Tokyo
TEL	03-5977-5038
Email	takaki_shu@kaken.co.jp

Public contact
Name of contact person	1st name Shochi Middle name Last name Irie
Organization	Milliman Inc.
Division name	Department of healthcare and data analysis
Zip code	1020083
Address	ACN Hanzomon Building 12F, 2-2-22 Kojimachi, Chiyoda-ku, Tokyo
TEL	03-5211-7033
Homepage URL
Email	c-shoichi.irie@milliman.com

Sponsor
Institute	KAKEN PHARMACEUTICAL CO.,LTD.
Institute
Department

Funding Source
Organization	KAKEN PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	INTAGE Healthcare Inc. Department of Orthopedics, Osaka Rosai Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Institute of Healthcare Data Science
Address	Sumitomo Shiba-Daimon Building 12F, 2-5-5 Shiba-Daimon, Minato-ku, Tokyo
Tel	03-5733-5010
Email	rihds@jmdc.co.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	2021 Year 12 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	856
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	2021 Year 10 Month 22 Day
Date of IRB	2021 Year 12 Month 16 Day
Anticipated trial start date	2022 Year 01 Month 05 Day
Last follow-up date	2022 Year 01 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 01 Month 27 Day

Other
Other related information	Nothing in particular

Management information
Registered date	2021 Year 12 Month 20 Day
Last modified on	2022 Year 05 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052321