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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024329
Receipt No. R000028017
Scientific Title Effect of Lumbar Traction for chronic Low Back Pain: A Cross-over Randomized Controlled Trial
Date of disclosure of the study information 2016/10/13
Last modified on 2017/04/11

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Basic information
Public title Effect of Lumbar Traction for chronic Low Back Pain: A Cross-over Randomized Controlled Trial
Acronym Low back pain Traction Therapy (LTT) Study
Scientific Title Effect of Lumbar Traction for chronic Low Back Pain: A Cross-over Randomized Controlled Trial
Scientific Title:Acronym Low back pain Traction Therapy (LTT) 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 effects of lumber traction 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 Ques-tionnaire)
Key secondary outcomes Assessment of functional impairment: Finger- floor distance (FFD)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Tow therapy A preceding group = "test" group: The traction for 10 minutes to which the vibration function was added. It's repeated for traction 30 seconds and suspension 5 seconds.
The load of traction: 40% of the body weight.
Three days a week for 1 week. And put 3 days (Saturday, Sunday, and Monday) as a washout period between 2 arms.
Interventions/Control_2 Tow therapy B preceding group = "control" group: The traction for 10 minutes. It's repeated for traction 30 seconds and suspension 5 seconds.
The load of traction: 40% of the body weight.
Three days a week for 1 week. And put 3 days (Saturday, Sunday, and Monday) as a washout period between 2 arms.
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 cerebro-vascular 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 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromoto Ito/ Hodeki Tanabe
Organization President, The Japanese Society of Musculoskeletal Medicine
President, The Japanese Clinical Orthopaedic Association
Division name The Office of the Japanese Society of Mus-culoskeletal Medicine/ The Office of the Japanese Clinical Orthopaedic Association
Zip code
Address c/o Department of Orthopaedic Surgery, Jichi Medical School 3311-1Yakushiji, Shimotuke-shi, 329-0498 Tochigi/ 6F, Okachimachi-Taitou Building, 4-26-8, Taitou, Taitou-ku, 110-0016 Tokyo
TEL 0258-58-7374
Email yuriko229@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masami Akai
Organization International University of Health and Welfare
Division name Graduate School
Zip code
Address 4F, Aoyama 1-Chome Tower, 1-3-3 Mina-mi-Aoyama, Minato-ku, 107-0062 Tokyo
TEL 03-6406-8621
Homepage URL
Email akai-masami@iuhw.ac.jp

Sponsor
Institute The Japanese Society of Musculoskeletal Medicine
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
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
2016 Year 10 Month 13 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 No longer recruiting
Date of protocol fixation
2016 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 07 Day
Last modified on
2017 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028017

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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