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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002288
Receipt No. R000002585
Scientific Title A Prospective Multicenter Study of Japanese Orthopaedic Association Back Pain Evaluation Questionnaire
Date of disclosure of the study information 2009/08/03
Last modified on 2014/03/13

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Basic information
Public title A Prospective Multicenter Study of Japanese Orthopaedic Association Back Pain Evaluation Questionnaire
Acronym A Prospective Multicenter Study of JOABPEQ
Scientific Title A Prospective Multicenter Study of Japanese Orthopaedic Association Back Pain Evaluation Questionnaire
Scientific Title:Acronym A Prospective Multicenter Study of JOABPEQ
Region
Japan

Condition
Condition Lumbar Disc Herniation and Lumbar Spinal Stenosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A verification of sensitivity of JOABPEQ for treatment results
Basic objectives2 Others
Basic objectives -Others In order to assess whether the JOABPEQ can reflect the change in patients' conditions after various treatments
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Japanese Orthopaedic Association Back Pain Evaluation Questionnaire
Key secondary outcomes Japanese Orthopaedic Association Assessment of Treatment for Low Back Pain

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent surgery due to Lumbar disc herniation or Lumbar spinal stenosis in the three years from August 2008.
Key exclusion criteria Petients who had
1)Other muscloskeletal diseases requireing medical treatment
2)Psychiatric disease,potenieally leading to inappropriate answers
3)Postoperative condition
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masabumi Miyamoto
Organization Nippon Medical School
Division name Orthopaedics
Zip code
Address Sendagi 1-1-5,Bunkyoku,Tokyo
TEL 03-5814-6209
Email miyamoto@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masabumi Miyamoto
Organization Nippon Medical School
Division name Orthopaedics
Zip code
Address Sendagi 1-1-5,Bunkyoku,Tokyo
TEL 03-5814-6209
Homepage URL
Email miyamoto@nms.ac.jp

Sponsor
Institute Clinical Outcome Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Institute
Department

Funding Source
Organization the Japanese Orthopaedic Association (JOA)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor the Japanese Society of Lumbar Spine Disorders
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 08 Month 03 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
1) In the case of LDH: Three categories of low back pain, social function and mental health, were correlated between patient-oriented awareness and JOABPEQ. However, lumbar function and walking ability were not correlated between two scores.we assessed the relationship SRQD (self-rating questionnaire for depression) score and the factor of psychological status in JOABPEQ. These factors were significant correlation in both preoperative and postoperative status , although the SRQD was not correlated with JOA score.

2) In the case of LCS,268 patients were surveyed between April 2008 and February 2010. Mean patient ages was 68.0 years.Mean JOA scores were 15.4, 22.8 and 23.0 points preoperatively, 6 and 12 months postoperatively. JOABPEQ showed good recovery was obtained only in two functional domains (low back pain and walking ability).The average VAS scores for low back was 5.7 preoperatively and 2.3 and 2.6 at 6 and 12 months postoperatively, respectively. The average VAS scores for leg pain was 6.3 preoperatively and 2.6 and 2.8 at each postoperative time point. Each score was apparently decreased after surgery in both groups.There was a correlation between JOA score and each functional category of JOABPEQ both preoperatively and postoperatively.There was a significant correlation between each factor of JOABPEQ and assessments by doctors and patients.
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
2008 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2011 Year 05 Month 01 Day
Date of closure to data entry
2011 Year 07 Month 01 Day
Date trial data considered complete
2011 Year 07 Month 01 Day
Date analysis concluded
2011 Year 07 Month 01 Day

Other
Other related information These results indicated that JOABPEQ is highly sensitive for assessing treatment results in both LSS and LDH patients. Furthermore, it was shown that there was a difference in the assessment of postoperative results between the LSS and LDH groups.
In the LSS group, there was a significant correlation between each functional category on JOABPEQ and the assessments by attending doctors and patients themselves. In the LDH group, there were poor correlations between JOABPEQ and assessments by doctors or patients, and there was a tendency toward fewer correlations at 12 months than at 6 months after surgery, even though there was a significant correlation in each functional category at 3 months after surgery.

Management information
Registered date
2009 Year 08 Month 03 Day
Last modified on
2014 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002585

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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