UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Home Exercise for chronic Low Back Pain: A Randomized Controlled Trial
Acronym	Low back pain Exercise Therapy (LET) Study
Scientific Title	Effect of Home Exercise for chronic Low Back Pain: A Randomized Controlled Trial
Scientific Title:Acronym	Low back pain Exercise Therapy (LET) Study
Region	Japan

Condition
Condition	chronic low back pain
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of home-based exercise for chronic low back pain.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Assessment of pain: VAS Assessment of disability: JLEQ (Japan Low-back pain Evaluation Questionnaire) and RDQ (Roland Morris Disability Questionnaire)
Key secondary outcomes	Assessment of impairment: Finger- floor distance

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Exercise (E) group: After delivering a brochure on low back pain exercise medical professionals directly give a lecture of the exercise. The therapeutic exercise is performed as home exercise. At the same time, proper posture guidance is performed using the form
Interventions/Control_2	NSAID (N) group: non-steroidal anti-inflammatory drugs (NSAIDs) is prescribed. At the same time, proper posture guidance is performed using the form
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	The patients satisfying the following conditions (1)-(4) are included. (1) Outpatients aged 20-65 years old. Both men and women are able to join the trial. (2) Patients who have had low back pain lasting more than 3 months. The symptom is chronic and no obvious neurological deficit. A chronologic fluctuation of the pain is not considered if the pain itself continues more than 3 months. (3) Low back pain is defined as the back ache occurring between the L1 spinal process and the gluteal sulcus. (4) The patient satisfying the following conditions: 1. Leg raising angle (by SLR maneuver) is less than 70 degrees. 2. There is no sensory deterioration by a superficial sensory examination. 3. The muscle strength in the lower limb is more than 4 by the Manual Muscle Testing (MMT). 4. The FNST (femoral nerve stretch test) is negative.
Key exclusion criteria	(1) Patient who had operation for lumbar spine in the past. (2) Patient who had spine/spinal cord neoplasm, infection, and fracture (compression fracture) (3) Patient who had severe osteoporosis (more than the III degree in the Jikei Med. Univ. classification) (4) Patient with psychiatric disorder. (5) Patient who had a history with cerebrovascular accident within 6 months before the day of agreement to enter the trial (6) Patient who had a history with myocardial infarction within 6 months before the day of agreement to enter the trial (7) Patient who received treatment for cardiac failure (8) Patient with liver dysfunction (9) Patient with renal dysfunction (10) Pregnant patient.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroshi Yamamoto
Organization	The Japanese Orthopaedic Association
Division name	Chief Director
Zip code
Address	Hongou 2-40-8, Bunkyo-ku, Tokyo, JAPAN
TEL	03-3816-3671
Email

Public contact
Name of contact person	1st name Middle name Last name Tsutomu Iwaya
Organization	National Rehabilitation Center for Persons with Disabilities
Division name	Training Center
Zip code
Address	4-1 Namiki, Tokorozawa, Saitama, JAPAN
TEL	04-2995-3100
Homepage URL
Email	iwaya@rehab.go.jp

Sponsor
Institute	The Japanese Orthopaedic Association
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	The Japanese Clinical Orthopaedic Association The Japanese Society for Musculoskeletal Rehabilitation
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2005 Year 10 Month 28 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
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	Completed
Date of protocol fixation	2004 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date	2004 Year 11 Month 01 Day
Last follow-up date	2005 Year 07 Month 01 Day
Date of closure to data entry	2005 Year 09 Month 01 Day
Date trial data considered complete	2005 Year 10 Month 01 Day
Date analysis concluded	2005 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 10 Month 28 Day
Last modified on	2005 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000340

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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