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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044425
Receipt No. R000050748
Scientific Title Comparison of neck exercises to reduce neck pressure pain threshold: randomized pre-post study
Date of disclosure of the study information 2021/06/10
Last modified on 2021/06/04

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Basic information
Public title Comparison of neck exercises to reduce neck pressure pain threshold: randomized pre-post study
Acronym Comparison of neck exercises to reduce neck pressure pain threshold: randomized pre-post study
Scientific Title Comparison of neck exercises to reduce neck pressure pain threshold: randomized pre-post study
Scientific Title:Acronym Comparison of neck exercises to reduce neck pressure pain threshold: randomized pre-post study
Region
Japan

Condition
Condition Those with neck symptoms
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the cranio-cervical flexion exercise is necessary for increasing neck pressure pain threshold or whether non-selective, retraction exercise causes an increase in the neck pressure pain threshold
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Neck pressure pain threshold (immediately before and after an intervention)
Key secondary outcomes Neck pain numerical rating scale (immediately before and after an intervention)
Neck range of motion (immediately before and after an intervention)
Demographics (age, gender, dominant hand) (immediately before an intervention)
Symptom duration (immediately before an intervention)
Symptom location (immediately before an intervention)
Neck disability index (immediately before an intervention)
P4 (immediately before an intervention)
EuroQol 5 Dimension (immediately before an intervention)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Cranio-cervical flexion (CCF) exercise will be undertaken by using a pressure feedback device placed behind the neck to guide the subject's nodding movements to eliminate lordosis of the cervical spine. The pressure of the device will be gradually increased from 22 mmHg to a maximum of 30 mmHg, and 3 sets of contraction for 2 seconds x 3 minutes will be performed at the maximum pressure that the subject can perform correctly without pain. A 3-minute break between each set will be given.
Interventions/Control_2 In the neck retraction exercise, the subject will retracts the head horizontally with over pressure at the end range. The subjects will perform 3 sets of repetitive exercises that move to the end range within pain control, with 3 minutes as one set. A 3-minute break between each set will be given.
Interventions/Control_3
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

Not applicable
Gender Male and Female
Key inclusion criteria Students in the Saitama Prefectural University
Neck Disability Index of 16% or more
Healthy individuals other than the neck symptoms including Katakori
Key exclusion criteria No history of a whiplash injury or fracture of the cervical spine
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Takasaki
Organization Saitama Prefectural university
Division name Physical Therapy
Zip code 3438540
Address Sannomiya 820, Koshigaya
TEL 0489734706
Email takasaki-hiroshi@spu.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Takasaki
Organization Saitama Prefectural University
Division name Physical Therapy
Zip code 3435840
Address Sannomiya 820, Koshigaya
TEL 0489734706
Homepage URL
Email takasaki-hiroshi@spu.ac.jp

Sponsor
Institute Saitama Prefectural 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 Saitama Prefectural University
Address Sannomiya 820, Koshigaya
Tel 0489710500
Email rinri@spu.ac.jp

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 10 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 30 Day
Date of IRB
2021 Year 05 Month 31 Day
Anticipated trial start date
2021 Year 06 Month 10 Day
Last follow-up date
2023 Year 03 Month 31 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 06 Month 04 Day
Last modified on
2021 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050748

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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