UMIN-CTR Clinical Trial

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

Chronic low back pain

Classification by specialty

Orthopedics

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

The Japanese Society of Musculoskeletal Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

The Japanese Clinical Orthopaedic Association

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

10

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

10

Month

07

Day

Last modified on

2017

Year

04

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028017