UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032372 |
|---|---|
| Receipt number | R000036861 |
| Scientific Title | The effect of lumbar mobilization on back muscles in people with low back pain |
| Date of disclosure of the study information | 2018/04/25 |
| Last modified on | 2018/04/25 07:27:59 |
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Basic information
Public title
The effect of lumbar mobilization on back muscles in people with low back pain
Acronym
The Effect of lumbar mobilization on back muscles
Scientific Title
The effect of lumbar mobilization on back muscles in people with low back pain
Scientific Title:Acronym
The Effect of lumbar mobilization on back muscles
Region
| North America |
Condition
Condition
Low Back Pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of grade III lumbar mobilization on the activity/contraction of erector spinae (ES) and lumbar multifidus (LM) muscles in people with LBP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Immediate effects on:
1-The activity amplitude of erector spinae muscle as measured by Surface Electromyography (EMG.
2.The contraction of lumbar multifidus as measured by ultrasound imaging.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Lumbar mobilization (grade III):five minutes (four bouts of 60 seconds each with rest time of 20 seconds between bouts)
Interventions/Control_2
Placebo (Light touch): five minutes
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
| 18 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) pain localized between the 12th rib and the inferior gluteal folds
2) pain greater than 3 out of 10 on 0-10 numerical rating pain scale
3) left side or bilateral LBP
Key exclusion criteria
1)symptoms radiating below the knee
2)body mass index (BMI) larger than 30 kg/m2
3)presence of neuromuscular diseases
4)lumbosacral conditions/pathology
5)pregnancy
6)night pain
7)progressive neurological deficit
8)unexplained weight loss
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Neena Sharma |
Organization
University of Kansas Medical Center
Division name
Physical Therapy & Rehabilitation Science
Zip code
Address
3901 Rainbow Blvd / MS2002 Kansas City, KS 66160
TEL
913-588-6799
nsharma@kumc.edu
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fahed Mehyar |
Organization
Eastern Washington University
Division name
Physical Therapy
Zip code
Address
310 N. Riverpoint Blvd., Box T Spokane, WA 99202-0002
TEL
5098281364
Homepage URL
fmehyar@ewu.edu
Sponsor or person
Institute
University of Kansas Medical Center
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2018 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.apta.org/CSM/Programming/AbstractViewer/
Number of participants that the trial has enrolled
Results
Compared to placebo group, mobilization group had higher LM contraction (p=0.03, effect size= 1.04), lower nEMG of ES at levels L1 (p =0.01, effect size= 1.39) and L4 (p =0.05, effect size= 1.76), and lower activity onset (faster contraction) of ES at the level of L1 (p=0.02, effect size=0.6).
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
| 2015 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 01 | Day |
Other
Other related information
Results were presented at Combined Section Meeting of American Physical Therapy Society , CSM APTA, Neworleans, LA, 2018.
Management information
Registered date
| 2018 | Year | 04 | Month | 25 | Day |
Last modified on
| 2018 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036861
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
