UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038445 |
|---|---|
| Receipt number | R000043806 |
| Scientific Title | Introduction of measures to prevent back pain in our hospital |
| Date of disclosure of the study information | 2019/10/31 |
| Last modified on | 2020/11/30 18:46:04 |
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Basic information
Public title
Introduction of measures to prevent back pain in our hospital
Acronym
Introduction of measures to prevent back pain in our hospital
Scientific Title
Introduction of measures to prevent back pain in our hospital
Scientific Title:Acronym
Introduction of measures to prevent back pain in our hospital
Region
| Japan |
Condition
Condition
Chronic low back pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prevention of recurrence of back pain and reduction of pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JOA Back Pain Evaluation Questionnaire for 8weeks
Key secondary outcomes
VAS(lumbar, lower limbs)
Keele STarT back
Pain-related disorder, lumbar vertebral dysfunction, gait dysfunction, social life disorder, psychological disorder
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Back pain management education 20 minutes/8weeks once in a lecture, distribution of leaflets
Interventions/Control_2
Back pain management education 20 minutes/8weeks once in a lecture, distribution of leaflets
And group exercise, cognitive behavioral therapy
Interventions/Control_3
Non-intervention
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
| 23 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Full-time nurse for 1 to 4 years
Use Keele STarT Back for those with a report of occupational back pain.
Intervention 1 is a low-risk group
Intervention 2 is a medium / high risk group
Non-intervention group has occupational low back pain but did not want to participate and obtained consent
Key exclusion criteria
Excludes those with acute lumbar, lower limb disease, and postpartum women
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Yoshida |
Organization
JCHO Kanazawa Hospital
Division name
Department of Rehabilitation
Zip code
920-8610
Address
15 Ha Okimachi, Kanazawa City, Ishikawa Prefecture
TEL
076-252-2200
shun-yoshida@kanazawa.jcho.go.jp
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Yoshida |
Organization
JCHO Kanazawa Hospital
Division name
Department of Rehabilitation
Zip code
920-8610
Address
15 Ha Okimachi, Kanazawa City, Ishikawa Prefecture
TEL
076-252-2200
Homepage URL
shun-yoshida@kanazawa.jcho.go.jp
Sponsor or person
Institute
JCHO Kanazawa Hospital
Institute
Department
Personal name
Funding Source
Organization
JCHO Kanazawa Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JCHO Kanazawa Hospital, Institutional Review Board
Address
15 Ha Okimachi, Kanazawa City, Ishikawa Prefecture
Tel
076-252-2200
shun-yoshida@kanazawa.jcho.go.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
独立行政法人地域医療機能推進機構金沢病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
21
Results
1)16 patients in the low risk group, 0 in the medium/high risk group, and 13 in the control group.
2)12 patients in the low-risk group and 9 in the control group with no deficit in JOABPEQ scores were included in the analysis; VAS went from 23.4 to 14 in the low-risk group and from 12 to 7.6 in the control group, and JOABPEQ interfered with work from 3.91 to 4 in the low-risk group and from 4.44 to 4.33 in the control group.
Results date posted
| 2020 | Year | 11 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average age is 29 years old.
51 people collected the questionnaire.
32 patients had occupational low back pain. Of these, 3 patients were examined in the past year and 4 patients had a history of childbirth. With/without preventive measures were 10/21 employees.
Affected tasks were "diaper changing" (27), "transfer" (20), and "changing positions" (15) in multiple responses.
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043806
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