UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Lumbar Traction for chronic Low Back Pain: A Cross-over Randomized Controlled Trial
Title of the study (Brief title)	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	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
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	Masami Akai
Organization	International University of Health and Welfare
Division name	Graduate School
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 10 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028017