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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044353
Receipt No. R000050662
Scientific Title The effect of exercise therapy according to the Directional Preference for neck symptoms
Date of disclosure of the study information 2021/06/10
Last modified on 2021/05/28

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Basic information
Public title The effect of exercise therapy according to the Directional Preference for neck symptoms
Acronym The effect of exercise therapy according to the Directional Preference for neck symptoms
Scientific Title The effect of exercise therapy according to the Directional Preference for neck symptoms
Scientific Title:Acronym The effect of exercise therapy according to the Directional Preference for neck symptoms
Region
Japan

Condition
Condition Those with neck symptoms for 1 week or more
Classification by specialty
Orthopedics Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to investigate whether the repetitive exercise of retraction and/or extension of the neck is effective for those with neck symptoms who have the directional preference (DP) for retraction and/or extension
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Global Recovery of Change Scale (3 and 6 weeks after the randomisation)
Key secondary outcomes Pain intensity: P4 (baseline, 3 and 6 weeks after the randomisation)
Quality of life: EuroQol 5 Dimension (baseline, 3 and 6 weeks after the randomisation)
Disability: Neck Disability Index, Patient Specific Functional Scale (baseline, 3 and 6 weeks after the randomisation)
Neck range of motion (baseline, 3 and 6 weeks after the randomisation)
Exercise adherence: Exercise adherence rating scale (3 and 6 weeks after the randomisation)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The intervention group will undertake home exercises of retraction or extension of the neck 10 to 15 times every 1-3 hours. The exercises will be corrected and modified once or twice a week.
Interventions/Control_2 The control group will act as usual.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria Neck symptoms for more than a week
Students in the Saitama Prefectural University
No intervention other than massage or pain relief patch
Neck Disability Index is 16% or higher
No history of trauma or surgery on the spine or upper limbs
Those who have no complications and are healthy except for the cervical symptoms
Key exclusion criteria No clear directional preference of retraction or extension of the neck during the baseline evaluation
Receiving medical managements in hospitals during the intervention period
Target sample size 40

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, Saitama
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 3438540
Address Sannomiya 820, Koshigaya, Saitama
TEL 0489734706
Homepage URL
Email takasaki-hiroshi@spu.ac.jp

Sponsor
Institute Saitama Prefectural University
Institute
Department

Funding Source
Organization Saitama Prefectural University
Organization
Division
Category of Funding Organization Other
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, Saitama
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
2020 Year 05 Month 11 Day
Date of IRB
2020 Year 06 Month 17 Day
Anticipated trial start date
2021 Year 06 Month 10 Day
Last follow-up date
2022 Year 01 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 05 Month 28 Day
Last modified on
2021 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050662

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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