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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030163
Receipt No. R000034449
Scientific Title Drawing-in maneuver using a pressure biofeedback unit for pain and muscular endurance in chronic neck pain
Date of disclosure of the study information 2018/03/02
Last modified on 2019/05/08

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Basic information
Public title Drawing-in maneuver using a pressure biofeedback unit for pain and muscular endurance in chronic neck pain
Acronym Drawing-in maneuver using a pressure biofeedback unit to improve chronic neck pain
Scientific Title Drawing-in maneuver using a pressure biofeedback unit for pain and muscular endurance in chronic neck pain
Scientific Title:Acronym Drawing-in maneuver using a pressure biofeedback unit to improve chronic neck pain
Region
Asia(except Japan)

Condition
Condition Chronic neck pain; Forward head posture
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of drawing-in maneuver using a pressure biofeedback unit with conservative training for relieving pain, and improving disability and deep cervical flexor muscular endurance in patients with neck pain and forward head posture
Basic objectives2 Others
Basic objectives -Others Differences between deep craniocervical flexor training group and deep craniocervical flexor training with Drawing-in maneuver using PBU group anf differences between two experimental groups with control group
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Pain; Neck disability Index; Deep flexor muscular endurance
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Deep craniocervical flexor training; 35 minutes a day, three times a week for 8 weeks
Interventions/Control_2 Deep craniocervical flexor training with Drawing-in maneuver using PBU; 35 minutes a day, three times a week for 8 weeks
Interventions/Control_3 Control group; active self-exercise
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 Inclusion criteria were pain between three and eight using VAS, neck disability index (NDI)(28-45%). 3), and neck pain at least within the last three months
Key exclusion criteria The exclusion criteria were as well acute neck pain, lasting less than three months, a previous history of neck or back surgery and presence of other neurological or orthopedic disorders affecting the neck or back, and receiving muscle relaxant treatment.
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 Faculty of Physical Education and Sport Sciences
Zip code 1571914911
Address Faculty of Physical Education, Kharazmi University, Kharazmi Blvd., Shahid Beheshti St., Karaj
TEL 00989357365993
Email letafatkaramir@yahoo.com

Public contact
Name of contact person
1st name Zohre
Middle name
Last name Khosrokiani
Organization Kharazmi University
Division name Faculty of Physical Education and Sport Sciences
Zip code 157191491
Address Faculty of Physical Education, Kharazmi University, Kharazmi Blvd., Shahid Beheshti St., Karaj
TEL 00989112133552
Homepage URL
Email z.khosrokiani@gmail.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 Kharazmi University
Address Faculty of Physical Education, Kharazmi University, Kharazmi Blvd., Shahid Beheshti St., Karaj, Alborz, Iran
Tel 02122222644
Email kinresct.khu@gmail.com

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
2018 Year 03 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 65
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
2017 Year 11 Month 26 Day
Date of IRB
2017 Year 11 Month 28 Day
Anticipated trial start date
2018 Year 01 Month 06 Day
Last follow-up date
2018 Year 05 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
2017 Year 11 Month 29 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034449

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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