UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007389
Receipt number 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 11:43:33

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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 or person

Institute

The McKenzie Institute International Japan Branch

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


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

Value
https://center6.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