UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024329 |
|---|---|
| Receipt number | 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 12:44:05 |
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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
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
akai-masami@iuhw.ac.jp
Sponsor or person
Institute
The Japanese Society of Musculoskeletal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028017
