UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Change of attitude towards self-management by Mechanical Diagnosis and Therapy in people with musculoskeletal problems: a prospective cohort study
Title of the study (Brief title)	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	Hiroshi Takasaki
Organization	Saitama Prefectural University
Division name	Physical Therapy
Address	Sannomiya 820, Koshigaya, Saitama
TEL	0489734706
Email	takasaki-hiroshi@spu.ac.jp

Public contact
Name of contact person	Hiroshi Takasaki
Organization	Saitama Prefectural University
Division name	Physical Therapy
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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