UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of lumbar mobilization on back muscles in people with low back pain
Title of the study (Brief title)	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	Neena Sharma
Organization	University of Kansas Medical Center
Division name	Physical Therapy & Rehabilitation Science
Address	3901 Rainbow Blvd / MS2002 Kansas City, KS 66160
TEL	913-588-6799
Email	nsharma@kumc.edu

Public contact
Name of contact person	Fahed Mehyar
Organization	Eastern Washington University
Division name	Physical Therapy
Address	310 N. Riverpoint Blvd., Box T Spokane, WA 99202-0002
TEL	5098281364
Homepage URL
Email	fmehyar@ewu.edu

Sponsor
Institute	University of Kansas Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.apta.org/CSM/Programming/AbstractViewer/
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).
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036861