UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018981 |
|---|---|
| Receipt number | R000021919 |
| Scientific Title | Effectiveness of Physical Therapy for Patients with Lumbar Spinal Stenosis |
| Date of disclosure of the study information | 2015/09/15 |
| Last modified on | 2020/08/05 06:34:42 |
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Basic information
Public title
Effectiveness of Physical Therapy for Patients with Lumbar Spinal Stenosis
Acronym
Effectiveness of Physical Therapy for Patients with Lumbar Spinal Stenosis
Scientific Title
Effectiveness of Physical Therapy for Patients with Lumbar Spinal Stenosis
Scientific Title:Acronym
Effectiveness of Physical Therapy for Patients with Lumbar Spinal Stenosis
Region
| Japan |
Condition
Condition
lumbar spinal stenosis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of home exercise program alone and in combination with
physical therapy in patients with lumbar spinal stenosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Zurich Claudication Questionnaire
(At 6weeks, 1 year, and 2 years after treatment)
Key secondary outcomes
visual analog scale of low back pain, leg pain and leg numbness
Japanese Orthopaedic Association Back Pain Evaluation Questionnaire
36-Item Short Form Health Survey
Roland Morris Disability Questionnaire
Pain Catastrophizing Scale
Pain Anxiety Symptoms Scale
Hospital Anxiety and Depression Scale
Self-Rating Questionnaire For Depression
Tampa scale for kinesiophobia
Pedmeter
(At 6weeks, 1 year, and 2 years after treatment)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
Interventions (twice a week for 6 weeks)
Supervised trunk and legs exercises
Manual therapy
body-weight-supported treadmill ambulation (20 to 30 minute)
cycle ergometer (20 to 30 minute)
home exercise program (trunk and legs exercises, walking)
Interventions/Control_2
Control (6 weeks)
home exercise program(trunk and legs exercises, walking)
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients presenting with symptoms of neurogenic claudication caused by lumbar spinal stenosis
Key exclusion criteria
trauma, osteoporosis, previous spine surgery, cauda equina syndrome, peripheral artery disorders, osteoarthrosis of the knee and/or hip, diabetes mellitus, cognitive impairment, a history of psychiatric illness, and treatment with epidural steroid injection or selective nerve root injection
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mamoru |
| Middle name | |
| Last name | Kawakami |
Organization
Wakayama Medical University Kihoku hospital
Division name
Spine Care Center
Zip code
649-7113
Address
219 Myoji, Katsuragi-cho, Ito-gun, Wakayama, Japan
TEL
0736-22-0066
kawakami@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Minetama |
Organization
Wakayama Medical University Kihoku hospital
Division name
Spine Care Center
Zip code
649-7113
Address
219 Myoji, Katsuragi-cho, Ito-gun, Wakayama, Japan
TEL
0736-22-0066
Homepage URL
masakazumasakazu910@hotmail.co.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
not applicable
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
Institutional Review Board at Wakayama Medical University
Address
811-1, Kimiidera, Wakayama city, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.ac.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 15 | 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
86
Results
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
Main results already published
Date of protocol fixation
| 2015 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 11 | Day |
Last modified on
| 2020 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021919
