UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007389
Receipt No. R000008705
Scientific Title Multicenter prospective cohort study on the effect of Mechanical Diagnosis and Therapy on spine related upper and lower limb pain
Date of disclosure of the study information 2012/03/01
Last modified on 2013/03/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multicenter prospective cohort study on the effect of Mechanical Diagnosis and Therapy on spine related upper and lower limb pain
Acronym Multicenter prospective cohort study on the effect of Mechanical Diagnosis and Therapy on spine related upper and lower limb pain
Scientific Title Multicenter prospective cohort study on the effect of Mechanical Diagnosis and Therapy on spine related upper and lower limb pain
Scientific Title:Acronym Multicenter prospective cohort study on the effect of Mechanical Diagnosis and Therapy on spine related upper and lower limb pain
Region
Japan

Condition
Condition Spine related upper and lower limb pain
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 which sub-group of spine related upper and lower limb pain responses well to Mechanical Diagnosis and Therapy(MDT)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain intensity will be assessed with verbally Numerical Pain Rating Scale(0-10). The magnitude of disability will be assessed with Self-Leeds Assessment of Neuropathic Symptoms and Signs(S-LANSS) Japanese version, a questionnaire developed by a research committee for screening neuropathic pain, the Neck Pain Disability Index Japanese version, Roland-Morris Disability Questionnaire Japanese version, Hospital Anxiety and Depression Scale Japanese version, Fear Avoidance and Beliefs Questionnaire Japanese version. 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).
Key secondary outcomes

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 Each patient will be treated with routine MDT assessments and treatments for 1 month. The MDT assessments includes main outcome measures described above as well as manual muscle testing, neurological examinations and repeated movement testing. Patients will be reassessed one month later and asked if they agree that their data is used for research. If patients agree and provide written consents, their MDT therapists will put patent's data into database.
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
18 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Those who will be treated by credential MDT therapists who are involved in this study;
Those who will have unilateral low back pain and leg pain radiating below the gluteal fold or unilateral neck pain and arm pain radiating below the shoulder for more than 6 weeks duration and a minimum pain intensity of 3 on the 11-point numerical rating scale.
Key exclusion criteria Those with bilateral pain radiating below the gluteal fold or the shoulder;
Those who will request other treatments except the MDT;
Those who will be treated with other treatments except the MDT based on decision makings by the therapists;
Those with history of lower quadrant surgery or trauma within the past 6 months;
Those with history of upper quadrant surgery or trauma within the past 6 months;
Those with history of nerve root block
within the past 4 weeks;
Those with history of neuropathic
pathology such as diabetes or polyneuropathies;
Those with history of vascular disease in the lower extremities;
Those with history of vascular disease in the upper extremities;
Those with systemic disease;
Those with inflammatory arthropathies;
Those with contraindications
to manual therapy techniques such as trauma,
infection or severe osteoporosis;
Those who cannot communicate well for some reasons.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Iwasada
Organization The McKenzie Institute International Japan Branch
Division name The McKenzie Institute International Japan Branch
Zip code
Address 2149-6 Mizuko Fujimi, Fujimi-shi Saitama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The McKenzie Institute International Japan Branch
Division name The McKenzie Institute International Japan Branch
Zip code
Address 3-1-3 Nishi-Shinjuku Shinjuku-ku Tokyo
TEL (03)53236022
Homepage URL
Email mckjapan2@hotmail.co.jp

Sponsor
Institute The McKenzie Institute International Japan Branch
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 YES
Study ID_1 SPTS2011001
Org. issuing International ID_1 The Society of Physical Therapy Science ethics committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 03 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 Terminated
Date of protocol fixation
2012 Year 01 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 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
2012 Year 02 Month 27 Day
Last modified on
2013 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008705

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.