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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039720
Receipt No. R000045301
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: A Randomized Controlled Trial
Date of disclosure of the study information 2020/03/05
Last modified on 2020/03/05

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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: A Randomized Controlled Trial
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: A Randomized Controlled Trial
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: A Randomized Controlled Trial
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: A Randomized Controlled Trial
Region
Asia(except Japan)

Condition
Condition pre-post intervention
Classification by specialty
Rehabilitation medicine Not applicable Adult
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 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain
Key secondary outcomes function,
quality of life
forward head posture

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 global postural reeducation/8 weeks
Interventions/Control_2 global postural reeducation plus Acoustic feedback/8 weeks
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
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,
physical therapy treatments in the last 6 months prior to the baseline assessment
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 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 03 Month 05 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 100
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
2019 Year 03 Month 09 Day
Date of IRB
2019 Year 03 Month 15 Day
Anticipated trial start date
2019 Year 03 Month 20 Day
Last follow-up date
2019 Year 06 Month 23 Day
Date of closure to data entry
2019 Year 07 Month 07 Day
Date trial data considered complete
2019 Year 08 Month 06 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 05 Day
Last modified on
2020 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045301

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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