UMIN-CTR Clinical Trial

Basic information
Public title	Influence of Therapeutic Exercises Program in Patients with Neck Pain
Acronym	Influence of Therapeutic Exercises Program in Patients with Neck Pain
Scientific Title	Influence of Therapeutic Exercises Program in Patients with Neck Pain
Scientific Title:Acronym	Influence of Therapeutic Exercises Program in Patients with Neck Pain
Region	Asia(except Japan)

Condition
Condition	pre-post
Classification by specialty	Rehabilitation medicine Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study was purposed to evaluate the effects of therapeutic exercises on posture, pain and muscle activation in patients with chronic neck pain exposed to anterior-posterior perturbation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain and disability
Key secondary outcomes	RMS, and activation onset of superficial neck muscles, posture

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Other
Interventions/Control_1	therapeutic exercises/
Interventions/Control_2	postural corrections
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	30 years-old <=
Age-upper limit	40 years-old >=
Gender	Female
Key inclusion criteria	neck pain
Key exclusion criteria	Neuropathies.radiculopathies, psychosocial problem, pregnancy, known fractures, functional or structural scoliosis; excessive thoracic kyphosis
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Amir Middle name Last name Letafatkar
Organization	kharazmi university
Division name	department of corrective exercises and sport injuries
Zip code	4352763633
Address	tehran-mirdamad-sout razan street, faculty of PE
TEL	009802122258084
Email	letafatkaramir@yahoo.com

Public contact
Name of contact person	1st name Amir Middle name Last name letafatkar
Organization	kharazmi University
Division name	department of biomechanics and sport injuries
Zip code	4353663663
Address	tehran-mirdamad-sout razan street, faculty of PE
TEL	00989195394692
Homepage URL
Email	letafatkaramir@yahoo.com

Sponsor
Institute	kharazmi university
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	kharazmi university
Address	gisha bridge, jalal aleahmad , kharazmi university,tehran
Tel	982182883590
Email	healthcontrol@kharazmi.ac.ir

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	2020 Year 04 Month 07 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_menu_form.cgi
Publication of results	Unpublished

Result
URL related to results and publications	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_menu_form.cgi
Number of participants that the trial has enrolled	60
Results	NA
Results date posted	2019 Year 11 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	NA
Participant flow	NA
Adverse events	none
Outcome measures	NA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 01 Month 04 Day
Date of IRB	2017 Year 10 Month 02 Day
Anticipated trial start date	2018 Year 02 Month 04 Day
Last follow-up date	2018 Year 05 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 30 Day
Last modified on	2019 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044171

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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