UMIN-CTR Clinical Trial

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
Email	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
Email	masakazumasakazu910@hotmail.co.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021919