UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020818 |
|---|---|
| Receipt number | R000024035 |
| Scientific Title | Change of attitude towards self-management by Mechanical Diagnosis and Therapy in people with musculoskeletal problems: a prospective cohort study |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2017/02/01 16:40:51 |
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Basic information
Public title
Change of attitude towards self-management by Mechanical Diagnosis and Therapy in people with musculoskeletal problems: a prospective cohort study
Acronym
Change of attitude towards self-management by Mechanical Diagnosis and Therapy in people with musculoskeletal problems: a prospective cohort study
Scientific Title
Change of attitude towards self-management by Mechanical Diagnosis and Therapy in people with musculoskeletal problems: a prospective cohort study
Scientific Title:Acronym
Change of attitude towards self-management by Mechanical Diagnosis and Therapy in people with musculoskeletal problems: a prospective cohort study
Region
| Japan |
Condition
Condition
Musculoskeletal problems
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study will be to investigate if interventions based on Mechanical Diagnosis and Therapy (MDT) enhances attitude towards self-management in people with musculoskeletal problems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The magnitude of self-management will be assessed with the Health Education impact Questionnaire(HeiQ) Japanese version. The primary outcomes will be assessed before the intervention and at one month after the intervention.
Key secondary outcomes
Pain intensity will be assessed with the P4 (0-40). The magnitude of disability will be assessed with the MOS 36-Item Short-Form Health Survey Japanese version. These secondary outcomes will be assessed before the intervention and at one month after the intervention.
Overall improvement will be measured using the Global Perceived Change Scale (GPC) where patients score their perceived change after the treatment on a 7-point scale ranging from: 1 (completely recovered) to 7 (worse than ever). The GPC will be assessed at one month after the intervention.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Participants will answer the outcome questionnaires before MDT assessments and treatments and at one month after the initiation of MDT intervention. The intervention will be undertaken 2 times a week maximally. The intervention will be provided by a credentialed MDT therapist.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who will be diagnosed as musculoskeletal disorders by a medical doctor
Those without contraindications to manual therapy techniques such as fracture, infection or severe osteoporosis
Key exclusion criteria
Those with an order of physical therapy after a surgical intervention
Those who cannot communicate well for some reasons
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takasaki |
Organization
Saitama Prefectural University
Division name
Physical Therapy
Zip code
Address
Sannomiya 820, Koshigaya, Saitama
TEL
0489734706
takasaki-hiroshi@spu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takasaki |
Organization
Saitama Prefectural University
Division name
Physical Therapy
Zip code
Address
Sannomiya 820, Koshigaya, Saitama
TEL
0489734706
Homepage URL
takasaki-hiroshi@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2016 | Year | 02 | 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
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
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 01 | Day |
Last modified on
| 2017 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024035
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
