UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044425 |
|---|---|
| Receipt number | 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 | 2023/04/26 11:11:47 |
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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
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
takasaki-hiroshi@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural 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
Saitama Prefectural University
Address
Sannomiya 820, Koshigaya
Tel
0489710500
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
20
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
| 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
| 2022 | Year | 06 | Month | 12 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 12 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 12 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050748
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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