UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054645 |
|---|---|
| Receipt number | R000062443 |
| Scientific Title | Effect of the McKenzie Method of Mechanical Diagnosis and Therapy on presenteeism for female teleworkers with Katakori: a 2-arm randomized control trial |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/06/30 10:01:02 |
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Basic information
Public title
An examination of the extent to which cervical exercises improve subjective work performance in female teleworkers with stiff neck and shoulders
Acronym
How much do cervical exercises improve subjective work performance in female teleworkers with stiff necks and shoulders?
Scientific Title
Effect of the McKenzie Method of Mechanical Diagnosis and Therapy on presenteeism for female teleworkers with Katakori: a 2-arm randomized control trial
Scientific Title:Acronym
Effect of the McKenzie Method of Mechanical Diagnosis and Therapy on presenteeism for female teleworkers with Katakori
Region
| Japan |
Condition
Condition
Presenteeism due to Katakori
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of reducing presenteeism with the remote Mackenzie method on female teleworkers with Katakori
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of Work Functioning Impairment Scale over the 12 months after the start of the intervention
Key secondary outcomes
Age (at the start of intervention)
Height (at the start of intervention)
StartMSK (at the start of intervention)
NEO Personality Inventory-Revised Five Factor Inventory (at the start of intervention)
Commodities (at the start of intervention)
Weight (at the start of intervention and at 3 and 12 months post-intervention)
Symptom location (at the start of intervention and at 3 and 12 months post-intervention)
Current work style (at the 3 and 12 months post-intervention)
Hospital visits related to Katakori (at the 3 and 12 months post-intervention)
Katakori Disability Index (at the start of the intervention and at the 3 and 12 months post-intervention)
Musculoskeletal Health Questionnaire (at the start of the intervention and at the 3 and 12 months after the intervention)
Kessler Psychological Distress Scale (at the start of the intervention and at the 3 and 12 months post-intervention)
Pain Self-Efficacy Questionnaire (at the start of the intervention and at the 3 and 12 months post-intervention)
Brief Job Stress Questionnaire (at the start of the intervention and at the 3 and 12 months post-intervention)
Response Styles Scale (at the start of the intervention and at the 3 and 12 months post-intervention)
Knowledge and Attitude of Pain (at the start of the intervention and at the 3 and 12 months post-intervention)
Coping Orientation to Problems Experienced Inventory (at the start of the intervention and at the 3 and 12 months post-intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A brochure on ergonomic work environments will be provided one.
Interventions/Control_2
In addition to providing a brochure on ergonomic work environments, the McKenzie method will be implemented for 12 weeks using Zoom. The frequency of the session is basically once a week for a maximum of 12 sessions.
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Those who have had Katakori for more than 3 months and feel that Katakori have reduced their work performance
Women living in Japan whose first language is Japanese
Those who have an environment where Zoom (with video) is available
Teleworking more than 70% of the week
Full-time employees (including self-employed)
Mainly desk-working
No diagnosis with any kind of permanent musculoskeletal disorder
Those who are not receiving any continuous treatment for Katakori in hospitals now and in the future (excluding massage, moxibustion, and acupuncture at osteopathic clinics and chiropractic clinics)
Those who are not visiting a hospital due to a musculoskeletal disorder in a region other than the neck
No diagnosis of mental, neurological, or respiratory disease
Those who are not pregnant
No history of neck surgery
No history of a whiplash injury within 3 months
Key exclusion criteria
Work Functioning Impairment Scale is less than 14 at the time of recruitment.
Those who, for any reason, has changed from working at home 70% or more to working at home less than 70% on a continuous basis due to a leave from work or resignation during the study period
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takasaki |
Organization
Saitama Prefectural University
Division name
Department of physical therapy
Zip code
3438540
Address
Sannomiya 820, Koshigaya, Saitama
TEL
0489734706
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
Department of physical therapy
Zip code
3438540
Address
Sannomiya 820, Koshigaya, Saitama
TEL
0489734706
Homepage URL
physical.therapy.takasaki@gmail.com
Sponsor or person
Institute
Saitama Prefectural University, Department of physical therapy, Hiroshi Takasaki
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Research Ethics Committee in Saitama Prefectural University
Address
Sannomiya 820, Koshigaya, Saitama
Tel
0489734120
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
| 2024 | Year | 07 | Month | 01 | 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
150
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
| 2024 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2027 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062443
