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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039713
Receipt No. 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

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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
Email 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
Email k-saito@zenshukai.com

Sponsor
Institute Zenshukai Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045292

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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