UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039713 |
|---|---|
| Receipt number | R000045292 |
| Scientific Title | The efficacy of a combination of exercise and duloxetine on physical disability in patients with non-specific chronic low back pain |
| Date of disclosure of the study information | 2020/03/06 |
| Last modified on | 2020/03/05 17:55:31 |
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Basic information
Public title
The efficacy of a combination of exercise and duloxetine on physical disability in patients with non-specific chronic low back pain
Acronym
The efficacy of a combination of exercise and duloxetine on physical disability in patients with non-specific chronic low back pain
Scientific Title
The efficacy of a combination of exercise and duloxetine on physical disability in patients with non-specific chronic low back pain
Scientific Title:Acronym
The efficacy of a combination of exercise and duloxetine on physical disability in patients with non-specific chronic low back pain
Region
| Japan |
Condition
Condition
Non-specific chronic low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study assessed the efficacy of combination treatment with exercise and duloxetine on non-specific CLBP and aimed to identify factors that contributed to improvement of LBP-induced disability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Roland-Morris Disability Questionnaire (RDQ)
Timepoints: baseline and 15 weeks after intervention
Key secondary outcomes
Numerical rationg scale (NRS), Pain catastrophizing scale (PCS), Hospital anxiety and depression scale (HADS)
Timepoints: baseline and 15 weeks after intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
A comobination of supervised physical exercise and duloxetine administration.
exercise: Patients were required to attend the program(tunk muscle stretching and strengthening) at outpatients rehabilitation center once a week or once in 2 weeks and advised to continue exercise at home for 15 weeks.
Duloxetine: Oral administration started frrom 20 mg before sleeping for 1 week and increased to 40 mg after 1 week and then maxium dose of 60 mg over 15 weeks with flexible dose method.
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
| 30 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with non-specific chronic low back pain of at least 3 months' duration.
Key exclusion criteria
Malalignment of the lumbar spine, spondylolysis, spondylolisthesis, disc herniation, infection, spinal compression fracture, and tumor. Furthermore,exclusion criteria included a history of previous lumbar spine surgery; severe cardiovascular, hepatic, or renal disorders; pregnancy; gait disturbance requiring crutches or a walker; any type of treatment for LBP within 1 month before the first visit; and psychogenic disorders.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Onda |
Organization
Zenshukai Hospital
Division name
Department of Orthopaedic Surgery
Zip code
379-2115
Address
54-1 Utsuboi-machi, Maebashi City, Gunma
TEL
027-261-5410
onda@zenshukai.com
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Mashimo |
Organization
Zenshukai Hospital
Division name
Department ofn Urology
Zip code
379-2115
Address
54-1 Utsuboi-machi, Maebashi City, Gunma
TEL
027-261-5410
Homepage URL
k-saito@zenshukai.com
Sponsor or person
Institute
Zenshukai Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Zenshukai Hospital
Address
54-1 Utsuboi-machi, Maebashi City, Gunma
Tel
027-261-5410
k-saito@zenshukai.com
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
善衆会病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 06 | 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
51
Results
A total of 42 patients (mean age, 63 years)of 51 enrolled were included in analysis. Overall, scores on the RDQ, NRS, and PCS (total score, magnification, helplessness) were significantly reduced at 15 weeks. An improvement of disability was confirmed in 22 patients (52%). A multivariate logistic regression analysis revealed that a reduction in HADS anxiety score over 15 weeks was a significant factor associated with an improvement in disability (adjusted odds ratio: 1.99; 95% CI: 1.26-3.65).
Results date posted
| 2020 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age, gender, BMI (body mass index), duration of symptoms.
Participant flow
This prospective study included consecutive patients diagnosed with non-specific CLBP at a single hospital between February 2017 and February 2019. All eligible patients recived supervised home-based exercise and duloxetine administration.The institutional review board of Zenshukai Hospital approved the study protocol (No. 17020101). Informed consent was obtained from all eligible participants.
Adverse events
Adverse events due to duloxetine were as follows: nausea (n = 2), somnolence (n = 1), headache (n = 1), and appetite loss (n = 1). No serious adverse events occurred throughout the study.
Outcome measures
RDQ, NRS, HADS, PCS
Plan to share IPD
none
IPD sharing Plan description
The full data used in this study will be provided by the corresponding author upon reasonable request.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 05 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045292
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