UMIN-CTR Clinical Trial

Basic information
Public title	The effect of adding high load suspension training to low load motor control exercises on pain, function, postural sway, GTA index and movement control in females with chronic non-specific low back pain
Acronym	The effect of adding high load suspension training to low load motor control exercises on pain, function, postural sway, GTA index and movement control in females with chronic non-specific low back pain
Scientific Title	The effect of adding high load suspension training to low load motor control exercises on pain, function, postural sway, GTA index and movement control in females with chronic non-specific low back pain
Scientific Title:Acronym	The effect of adding high load suspension training to low load motor control exercises on pain, function, postural sway, GTA index and movement control in females with chronic non-specific low back pain
Region	Asia(except Japan)

Condition
Condition	pre- post; laboratory study
Classification by specialty	Medicine in general Rehabilitation medicine Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	compare the effect of adding suspended training with high load to motor control exercises on pain, function and postural sway in women with chronic nonspecific LBP
Basic objectives2	Others
Basic objectives -Others	function and postural sway
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pain
Key secondary outcomes	function GTA index movement control

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine Other
Interventions/Control_1	intervention 1: motor control training
Interventions/Control_2	intervention 2: motor control combined with suspension training
Interventions/Control_3	control: placebo
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	35 years-old <=
Age-upper limit	45 years-old >=
Gender	Female
Key inclusion criteria	chronic low back pain
Key exclusion criteria	other musculoskeletal disorders
Target sample size	135

Research contact person
Name of lead principal investigator	1st name Middle name Last name Gelareh alamouti
Organization	kharazmi university
Division name	department of biomechanics and sport injuries
Zip code
Address	tehran-mirdamad-sout razan street, faculty of PE
TEL	009802122258084
Email	std_gelarehalamooti@khu.ac.ir

Public contact
Name of contact person	1st name Middle name Last name amir letafatkar
Organization	kharazmi University
Division name	department of biomechanics and sport injuries
Zip code
Address	tehran-mirdamad-sout razan street, faculty of PE
TEL	00989195394692
Homepage URL
Email	letafatkaramir@yahoo.com

Sponsor
Institute	kharazmi
Institute
Department

Funding Source
Organization	self funding
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
Email

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	2019 Year 08 Month 17 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	Completed
Date of protocol fixation	2018 Year 11 Month 19 Day
Date of IRB	2018 Year 11 Month 20 Day
Anticipated trial start date	2018 Year 11 Month 21 Day
Last follow-up date	2019 Year 02 Month 05 Day
Date of closure to data entry	2019 Year 03 Month 10 Day
Date trial data considered complete	2019 Year 03 Month 10 Day
Date analysis concluded	2019 Year 03 Month 20 Day

Other
Other related information

Management information
Registered date	2018 Year 11 Month 19 Day
Last modified on	2019 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039780