UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043938 |
|---|---|
| Receipt number | 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 14:29:57 |
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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
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
njavdaneh68@gmail.com
Sponsor or person
Institute
kharazmi university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050178
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