UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016669 |
|---|---|
| Receipt number | R000019345 |
| Scientific Title | Socioeconomic evaluation of clinical pharmacology to chronic low back pain |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2016/03/18 17:46:17 |
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Basic information
Public title
Socioeconomic evaluation of clinical pharmacology to chronic low back pain
Acronym
SECP-CLBP
Scientific Title
Socioeconomic evaluation of clinical pharmacology to chronic low back pain
Scientific Title:Acronym
SECP-CLBP
Region
| Japan |
Condition
Condition
Patients who have been clinically diagnosed with non-specific low back pain or sciatica with a chief symptom of low back pain, and have been experiencing pain for at least 12 weeks will be considered for inclusion. Patients with pain caused by infections, trauma, and visceral diseases will be excluded.
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Socioeconomic evaluation of clinical pharmacology to chronic low back pain
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to evaluate the socioeconomic effectiveness of drug therapy (pain management) in patients with noncancerous chronic low back pain. The evaluation is expected to contribute to the establishment of the evidence for proactive choice of effective drug therapy for chronic low back pain or to the promotion of medical resource investment which is appropriate to the value of drug therapy.
To examine the characteristics of chronic, intractable low back pain and the social transitions surrounding medical care, we will analyze (1) cost-effectiveness to evaluate prescription choice in consideration of economical aspects, and (2) efficacy of prescription choice based on a new set of values, including the patient's viewpoint (patient utility values).
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cost-benefit: Medical fees/Quality-adjusted life year (Unit: Yen/QALY),
Cost-effectiveness: Cost of medical services/Scores of various health indicators (Unit: Yen/Score)
Key secondary outcomes
Efficacy-related endpoint:
Utility for patients
- Preference-based measures -> EQ-5D (EuroQol 5 Dimension)(Unit: QALY)
Health level of patients
- Comprehensive measures -> SF-8 (MOS short-form 8-item health survey)(Unit: Score)
- Disease-specific indicators for low back pain -> RDQ (Roland-Morris Disability Questionnaire), JOA-BPEQ (Japanese Orthopaedic Association Back Pain Evaluation Questionnaire), VAS (Visual Analogue Scale)(Unit: Score)
Cost-related endpoint
Medical fee bill(Unit: Points or Yen), Cost of medical services(Unit: Yen)
Base
Study type
Observational
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Men or women aged 20 to 85 years
2) Patients who have been experiencing low back pain for at least 12 weeks despite treatment with acetaminophen, NSAIDS (propionate, arylacetic acid, oxicam, and coxib), tramadol, etc.; or patients who have been experiencing low back pain for at least 12 weeks and have not received drugs.
3) Patients with BS-POP(Brief Scale for Psychiatric Problems in Orthopaedic Patients) scores that do not meet the criteria for psychiatric problems, which is 10 points or more for physicians and 15 points or more for patients.
Key exclusion criteria
The following are exclusion criteria established for the safety of the study and the reliability of the endpoint evaluation.
1) Patients with complicated hemorrhagic gastrointestinal diseases.
2) Patients with serious cardiac, hepatic, or renal function disorders, or other serious complications.
3) Patients with advanced blood disorders (bleeding tendency, etc.).
4) Patients with dementia or other psychiatric disorders who would be expected to have difficulties with the evaluation.
5) Patients with a history of alcohol or drug dependence.
6) Patients diagnosed with a malignant tumor within the previous 5 years.
Other patients considered inappropriate for study participation will be excluded by the investigator.
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Matsuyama |
Organization
Hamamatsu University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2297
spine-yu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Yoshikawa |
Organization
Osaka UniversityGraduate School of Medicine
Division name
Department of Orthopedics
Zip code
Address
2-2, Yamadaoka Suita-shi, Osaka, 565-0871, JAPAN
TEL
06-6879-3552
Homepage URL
yhideki@ort.med.osaka-u.ac.jp
Sponsor or person
Institute
The Japanese Society for Spine Surgery and Related Research
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society for Spine Surgery and Related Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪大学医学部附属病院（大阪府）、浜松医科大学（静岡県）、札幌医科大学附属病院（北海道）、福島県立医科大学附属病院（福島県）、筑波大学医学部附属病院（茨城県）、獨協医科大学附属病院（栃木県）、自治医科大学附属病院（栃木県）、埼玉医科大学附属病院（埼玉県）、千葉大学附属病院（千葉県）、帝京大学ちば総合医療センター（千葉県）、慈恵医科大学附属病院（東京都）、慶応義塾大学医学部附属病院（東京都）、日本大学医学部附属病院（東京都）、東海大学医学部附属病院（神奈川県）、富山大学医学部附属病院（富山県）、金沢大学医学部附属病院（金沢県）、福井大学医学部附属病院（福井県）、山梨大学医学部附属病院（山梨県）、名古屋大学医学部附属病院（愛知県）、京都大学医学部附属病院（京都県）、大阪市立大学医学部附属病院（大阪府）、川崎医科大学附属病院（岡山県）、山口大学医学部附属病院（山口県）、鹿児島大学医学部附属病院（鹿児島県）、九州大学医学部附属病院（福岡県）、東京大学医学部附属病院（東京都）、和歌山県立医科大学附属病院（和歌山県）、東京医科歯科大学医学部附属病院（東京都）、大阪医科大学附属病院（大阪府）、秋田大学附属病院（秋田県）、北里大学附属病院（神奈川県）、神戸大学附属病院（兵庫県） 等
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 01 | 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
| 2013 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective, Nonrandomized, Open Study (Observational Study)
Management information
Registered date
| 2015 | Year | 03 | Month | 01 | Day |
Last modified on
| 2016 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019345
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