UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039110 |
|---|---|
| Receipt number | R000044605 |
| 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 | 2020/05/02 |
| Last modified on | 2020/05/31 20:58:21 |
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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
| Medicine in general | 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
Disability
function,
quality of life
forward head 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
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
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
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
letafatkaramir@yahoo.com
Sponsor or person
Institute
kharazmi university
Institute
Department
Personal name
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
982182883595
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 | 05 | Month | 02 | 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
| 2020 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 04 | Month | 19 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 09 | Day |
Last modified on
| 2020 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044605
