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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043938
Receipt No. R000050178
Scientific Title Focus on the scapula region in the rehabilitation of chronic neck pain is effective in improving the symptoms
Date of disclosure of the study information 2021/06/06
Last modified on 2021/04/16

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Basic information
Public title The effect of neck and scapula stabilization exercises on pain, scapula alignment, forward head angle and range of motion in patients with chronic neck pain and scapular dyskinesia
Acronym effect of neck and scapula stabilization exercises on chronic neck pain
Scientific Title Focus on the scapula region in the rehabilitation of chronic neck pain is effective in improving the symptoms
Scientific Title:Acronym Focus on the scapula is effective in improving the symptoms of neck pain
Region
Asia(except Japan)

Condition
Condition Pre- post
Classification by specialty
Medicine in general Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect of neck and scapula stabilization exercises on pain, scapula alignment, forward head angle and range of motion in patients with chronic neck pain and scapular dyskinesia
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain intensity.Pain intensity measured by the visual analog scale (VAS). The patients will be instructed to grade their average intensity of neck pain experienced in the past week on a 0-10 cm horizontal line (0 = no pain and 10 = worst pain imaginable). A change of two points or more was identified as the minimal clinically important difference in patients with chronic neck pain 18.
Key secondary outcomes scapula alignment, forward head angle, and range of motion.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 6-week neck stabilization exercises.The exercises were performed three days per week, for six weeks (18 sessions in total).
The composition and progress of the exercises are designed according to the exercises presented in previous studies17, 22-24. The exercises included craniocervical flexion using stabilizer pressure biofeedback unit, neck isometric exercises using Thera-band, and neck stability exercises in supine, prone, quadrupedal and bipedal position. Further details on the exercise protocol are reported in the study by Javdaneh et al 17. NET was performed once a day (three days per week, for six weeks).
Interventions/Control_2 6-week neck and scapular stabilization exercises (combined).The exercises were performed three days per week, for six weeks (18 sessions in total).
Interventions/Control_3 8 week plasbo.The control group did not receive any intervention during the study. After the last measurement, they received a comprehensive rehabilitation program.
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
18 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria ongoing neck pain for at least 3 months.
Key exclusion criteria Exclusion criteria were any previous shoulder or neck surgery, fibromyalgia, cervical radiculopathy/myelopathy, having undergone any physical therapy intervention in the previous 3 months or poor general health status that would interfere with the exercises during the study.
Target sample size 66

Research contact person
Name of lead principal investigator
1st name Norollah
Middle name
Last name Javdaneh
Organization kharazmi university
Division name department of biomechanics and sport injuries
Zip code 009822258085
Address tehran-mirdamad-sout razan street, faculty of PE
TEL 00982122258084
Email njavdaneh68@gmail.com

Public contact
Name of contact person
1st name Norollah
Middle name
Last name javdaneh
Organization kharazmi university
Division name department of biomechanics and sport injuries
Zip code 009822258085
Address tehran-mirdamad-sout razan street, faculty of PE
TEL 00982122258084
Homepage URL
Email njavdaneh68@gmail.com

Sponsor
Institute kharazmi university
Institute
Department

Funding Source
Organization Non
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 tarbiatmodares university
Address gisha bridge, jalal aleahmad , tarbiatmodares university,tehran
Tel 982182883590
Email healthcontrol@modares.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
2021 Year 06 Month 06 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 66
Results Assessed for eligibility (n= 130)
Randomized (n= 72)
Results date posted
2021 Year 04 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 12 Month 20 Day
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 05 Month 11 Day
Date of IRB
2019 Year 07 Month 19 Day
Anticipated trial start date
2020 Year 09 Month 19 Day
Last follow-up date
2020 Year 10 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 15 Day
Last modified on
2021 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050178

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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