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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020818
Receipt No. 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

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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
Email 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
Email takasaki-hiroshi@spu.ac.jp

Sponsor
Institute Saitama Prefectural University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024035

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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