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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036565
Receipt No. R000041660
Scientific Title Efficacy of deep cervical flexor motor-control training with and without lumbar muscle motor control training in women with chronic neck pain
Date of disclosure of the study information 2019/07/20
Last modified on 2019/07/26

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Basic information
Public title Efficacy of deep cervical flexor motor-control training with and without lumbar muscle motor control training in women with chronic neck pain
Acronym Efficacy of deep cervical flexor motor-control training with and without lumbar muscle motor control training in women with chronic neck pain
Scientific Title Efficacy of deep cervical flexor motor-control training with and without lumbar muscle motor control training in women with chronic neck pain
Scientific Title:Acronym Efficacy of deep cervical flexor motor-control training with and without lumbar muscle motor control training in women with chronic neck pain
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 The purpose of this study was to investigate whether adding lumbar motor control training with a pressure biofeedback unit (PBU) improves outcomes of a conservative deep cervical flexor (DCF) motor control program on neck pain, neck disability, and DCF endurance in middle-aged women with moderate chronic NP and FHP compared to a control
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain
Key secondary outcomes disability,
posture
health status
endurance

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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
Other
Interventions/Control_1 Conventional Group / 2 months
Interventions/Control_2 Conventional + MCE using PBU exercise Group/ 2 months
Interventions/Control_3 postural corrections
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
30 years-old <=
Age-upper limit
50 years-old >=
Gender Female
Key inclusion criteria women with moderately severe,
chronic NP we included women who rated their worst pain over the last 24-hours between three and eight using the visual analog scale (VAS),
baseline neck disability index (NDI) scores between 28% and 45% and pain lasting longer than 3 months.

Key exclusion criteria acute NP less than three months,
previous history of neck or back surgery,
presence of neurological signs,
rheumatoid arthritis affecting the neck or back,
currently using muscle relaxer medication
Target sample size 65

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 009822258085
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 009822258085
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 Self funding
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
2019 Year 07 Month 20 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
2019 Year 04 Month 20 Day
Date of IRB
2019 Year 02 Month 20 Day
Anticipated trial start date
2019 Year 04 Month 30 Day
Last follow-up date
2019 Year 07 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 21 Day
Last modified on
2019 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041660

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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