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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000269
Receipt No. R000000340
Scientific Title Effect of Home Exercise for chronic Low Back Pain: A Randomized Controlled Trial
Date of disclosure of the study information 2005/10/28
Last modified on 2005/10/28

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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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