UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044353
Receipt number 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 2023/05/30 09:48:48

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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 or person

Institute

Saitama Prefectural University

Institute

Department

Personal name



Funding Source

Organization

Saitama Prefectural University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

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

No longer recruiting

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

2021 Year 12 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

2023 Year 05 Month 30 Day



Link to view the page

Value
https://center6.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