Unique ID issued by UMIN | UMIN000039713 |
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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 |
The efficacy of a combination of exercise and duloxetine on physical disability in patients with non-specific chronic low back pain
The efficacy of a combination of exercise and duloxetine on physical disability in patients with non-specific chronic low back pain
The efficacy of a combination of exercise and duloxetine on physical disability in patients with non-specific chronic low back pain
The efficacy of a combination of exercise and duloxetine on physical disability in patients with non-specific chronic low back pain
Japan |
Non-specific chronic low back pain
Orthopedics |
Others
NO
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.
Efficacy
Roland-Morris Disability Questionnaire (RDQ)
Timepoints: baseline and 15 weeks after intervention
Numerical rationg scale (NRS), Pain catastrophizing scale (PCS), Hospital anxiety and depression scale (HADS)
Timepoints: baseline and 15 weeks after intervention
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Other |
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.
30 | years-old | <= |
79 | years-old | >= |
Male and Female
Patients with non-specific chronic low back pain of at least 3 months' duration.
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.
50
1st name | Akira |
Middle name | |
Last name | Onda |
Zenshukai Hospital
Department of Orthopaedic Surgery
379-2115
54-1 Utsuboi-machi, Maebashi City, Gunma
027-261-5410
onda@zenshukai.com
1st name | Toru |
Middle name | |
Last name | Mashimo |
Zenshukai Hospital
Department ofn Urology
379-2115
54-1 Utsuboi-machi, Maebashi City, Gunma
027-261-5410
k-saito@zenshukai.com
Zenshukai Hospital
No funding
Other
Zenshukai Hospital
54-1 Utsuboi-machi, Maebashi City, Gunma
027-261-5410
k-saito@zenshukai.com
NO
善衆会病院(群馬県)
2020 | Year | 03 | Month | 06 | Day |
Unpublished
51
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).
2020 | Year | 03 | Month | 05 | Day |
Age, gender, BMI (body mass index), duration of symptoms.
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 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.
RDQ, NRS, HADS, PCS
none
The full data used in this study will be provided by the corresponding author upon reasonable request.
Completed
2017 | Year | 01 | Month | 05 | Day |
2017 | Year | 02 | Month | 01 | Day |
2017 | Year | 02 | Month | 02 | Day |
2019 | Year | 06 | Month | 25 | Day |
2020 | Year | 03 | Month | 05 | Day |
2020 | Year | 03 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045292
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