UMIN-CTR Clinical Trial

Basic information
Public title	Adding Acoustic Feedback to Global Postural Re-education to improve Neck Pain, Posture, Quality of Life, and Function in People with Nonspecific Neck Pain
Acronym	Adding Acoustic Feedback to Global Postural Re-education to improve Neck Pain, Posture, Quality of Life, and Function in People with Nonspecific Neck Pain
Scientific Title	Adding Acoustic Feedback to Global Postural Re-education to improve Neck Pain, Posture, Quality of Life, and Function in People with Nonspecific Neck Pain
Scientific Title:Acronym	Adding Acoustic Feedback to Global Postural Re-education to improve Neck Pain, Posture, Quality of Life, and Function in People with Nonspecific Neck Pain
Region	Asia(except Japan)

Condition
Condition	university labratory
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the effect of adding (AF) to an eight-week global postural reeducation (GPR) on neck pain, function, quality of life and forward head posture (FHP) in patients with chronic neck pain and FHP.
Basic objectives2	Others
Basic objectives -Others	to evaluate the effect of adding (AF) to an eight-week global postural reeducation (GPR) on neck pain, function, quality of life and forward head posture (FHP) in patients with chronic neck pain and FHP.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pain
Key secondary outcomes	Forward head posture endurance quality of life

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Acoustic feedback (AF)
Interventions/Control_2	global postural reeducation (GPR)
Interventions/Control_3	control
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	computer workers (at least 4 hours), aged between 20 and 60 years, neck pain between 3-8 cm on a visual analog scale (VAS), chronic nonspecific NP lasting for at least 3 months.
Key exclusion criteria	specific causes of NP (e.g. systemic, rheumatic, neuromuscular diseases), central or peripheral neurological signs, cognitive impairment, spinal surgery, or physical therapy treatments
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Amir Middle name Last name Letafatkar
Organization	kharazmi University
Division name	department of biomechanics and sport injuries
Zip code	4352763633
Address	tehran-mirdamad-sout razan street, faculty of PE
TEL	009802122258084
Email	amir.letafatkar@khu.ac.ir

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	author 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	Amir Letafatkar
Tel	982122258085
Email	letafatkaramiryahoo.com

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 08 Month 26 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_up_reg_f5.cgi
Publication of results	Unpublished

Result
URL related to results and publications	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled	100
Results	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_up_reg_f5.cgi
Results date posted	2020 Year 01 Month 01 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	Completed
Date of protocol fixation	2018 Year 09 Month 11 Day
Date of IRB	2018 Year 04 Month 16 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2019 Year 01 Month 01 Day
Date of closure to data entry	2020 Year 01 Month 01 Day
Date trial data considered complete	2020 Year 01 Month 01 Day
Date analysis concluded	2020 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date	2018 Year 08 Month 08 Day
Last modified on	2021 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038393