UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002288 |
|---|---|
| Receipt number | 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 12:23:27 |
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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
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
miyamoto@nms.ac.jp
Sponsor or person
Institute
Clinical Outcome Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002585
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