Unique ID issued by UMIN | UMIN000007389 |
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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 |
Multicenter prospective cohort study on the effect of Mechanical Diagnosis and Therapy on spine related upper and lower limb pain
Multicenter prospective cohort study on the effect of Mechanical Diagnosis and Therapy on spine related upper and lower limb pain
Multicenter prospective cohort study on the effect of Mechanical Diagnosis and Therapy on spine related upper and lower limb pain
Multicenter prospective cohort study on the effect of Mechanical Diagnosis and Therapy on spine related upper and lower limb pain
Japan |
Spine related upper and lower limb pain
Orthopedics | Rehabilitation medicine |
Others
NO
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)
Efficacy
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).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
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.
18 | years-old | <= |
75 | years-old | > |
Male and Female
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.
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.
500
1st name | |
Middle name | |
Last name | Yoshihiro Iwasada |
The McKenzie Institute International Japan Branch
The McKenzie Institute International Japan Branch
2149-6 Mizuko Fujimi, Fujimi-shi Saitama
1st name | |
Middle name | |
Last name |
The McKenzie Institute International Japan Branch
The McKenzie Institute International Japan Branch
3-1-3 Nishi-Shinjuku Shinjuku-ku Tokyo
(03)53236022
mckjapan2@hotmail.co.jp
The McKenzie Institute International Japan Branch
None
Self funding
YES
SPTS2011001
The Society of Physical Therapy Science ethics committee
2012 | Year | 03 | Month | 01 | Day |
Unpublished
Terminated
2012 | Year | 01 | Month | 14 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 02 | Month | 27 | Day |
2013 | Year | 03 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008705
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