UMIN-CTR Clinical Trial

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