UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030163 |
|---|---|
| Receipt number | 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 14:50:31 |
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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
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
z.khosrokiani@gmail.com
Sponsor or person
Institute
Kharazmi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034449
