UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049297
Receipt number R000056147
Scientific Title Does a lumbar roll make a difference in muscle activity and posture during prolonged typing tasks in those with neck symptoms?: A Randomized Crossover Trial
Date of disclosure of the study information 2022/10/24
Last modified on 2025/04/26 13:23:40

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Basic information

Public title

Does a lumbar roll make a difference in muscle activity and posture during prolonged typing tasks in those with neck symptoms?: A Randomized Crossover Trial

Acronym

Does a lumbar roll make a difference in muscle activity and posture during prolonged typing tasks in those with neck symptoms?: A Randomized Crossover Trial

Scientific Title

Does a lumbar roll make a difference in muscle activity and posture during prolonged typing tasks in those with neck symptoms?: A Randomized Crossover Trial

Scientific Title:Acronym

Does a lumbar roll make a difference in muscle activity and posture during prolonged typing tasks in those with neck symptoms?: A Randomized Crossover Trial

Region

Japan


Condition

Condition

Those with neck symptoms

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine whether the activity and posture of the neck and trunk during a prolonged typing task differ with and without lumbar roll in those with neck symptoms

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

EMG Relative rest time of right splenius capitis, upper right trapezius, middle right trapezius, right sternocleidomastoid, right serratus anterior, right longissimus, and right pectoralis major muscles for 60 min

Key secondary outcomes

60-minute cranio-vertebral angle
60-minute cranio-cervical angle
Horizontal angle between left and right scapula at 60 minutes
Anterior-posterior pelvic tilt angle at 60 minutes
Sagittal angle between the pelvic plane and T2 level at 60 minutes
Symptom duration
Location of symptoms before the task
Pain intensity according to the P4 before the task
Quality of life according to the EQ5D before the task
Katakori Disability Index before the task
An 11-point numerical rating scale for bothersomeness due to neck symptoms before the task
11-level neck symptom annoyance immediately after the task


Base

Study type

Interventional


Study design

Basic design

Cross-over

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

Device,equipment

Interventions/Control_1

60 min-taping tasks with a lumbar roll

Interventions/Control_2

60 min-taping tasks without a lumbar roll

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

Students and staff of Saitama Prefectural University
Those who have neck symptoms including Katakori for at least the last week and have a Neck Disability Index (NDI) of 16% or higher
Those who have used computers at least two days a week for a total of at least two hours a week

Key exclusion criteria

Those with a history of whiplash or neck fracture or surgery
Those who are unable to sit in the experimental environment for one hour continuously for any reason.
Those who have difficulty in typing for any reason.
Those who are unable to perform standard EMG pretreatment for any reason.

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, Saitama

TEL

0489734706

Email

physical.therapy.takasaki@gmail.com


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

physical.therapy.takasaki@gmail.com


Sponsor or person

Institute

Saitama Prefectural University

Institute

Department

Personal name



Funding Source

Organization

Saitama Prefectural University Research Grant

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

0489734120

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

2022 Year 10 Month 24 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

60

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

2022 Year 10 Month 24 Day

Date of IRB

2022 Year 03 Month 31 Day

Anticipated trial start date

2022 Year 10 Month 25 Day

Last follow-up date

2024 Year 09 Month 30 Day

Date of closure to data entry

2024 Year 09 Month 30 Day

Date trial data considered complete

2024 Year 09 Month 30 Day

Date analysis concluded

2024 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2022 Year 10 Month 24 Day

Last modified on

2025 Year 04 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056147