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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005332
Receipt No. R000006336
Scientific Title Effects of compression on myofascial trigger points in patients with acute-subacute neck or low back pain: randomized controlled trials.
Date of disclosure of the study information 2011/03/28
Last modified on 2016/01/26

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Basic information
Public title Effects of compression on myofascial trigger points in patients with acute-subacute neck or low back pain: randomized controlled trials.
Acronym Effects of compression on myofascial trigger points in patients with acute-subacute neck or low back pain (E-CMTP).
Scientific Title Effects of compression on myofascial trigger points in patients with acute-subacute neck or low back pain: randomized controlled trials.
Scientific Title:Acronym Effects of compression on myofascial trigger points in patients with acute-subacute neck or low back pain (E-CMTP).
Region
Japan

Condition
Condition Acute-subacute neck or low back pain
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate effectiveness of compression on myofascial trigger points in patients with acute-subacute neck or low back pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Visual Analog Scale (VAS)
Key secondary outcomes Roland-Morris Disability Questioner(RDQ)
Neck Disability Index (NDI)
Range of Motion (ROM)
Pain pressure threshold (PPT)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Trigger point
Interventions/Control_2 Non-Trigger point
Interventions/Control_3 Superficial massage
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
16 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients who complain of neck or low back pain within 3 months from the onset.
2)Patients without drug prescription, or patients who take drugs such as those for cardiovascular and endocrinological disorders for more than 1 month, and its dosage and kinds of the drugs are constant during drug prescription.
3)Written informed consent singed by themselves on the patients' guardians should be obtained.
Key exclusion criteria 1) Patients with The past history of spinal surgery.
2) Patients with spinal fracture or dislocation.
3) Patients with neurological signs (positive straight leg raising test, Femoral nerve stretch test, Jackson test, Spurling test, muscle weakness, paresthesia, or abnormal reflexes).
4) Patients who need to take analgesic drugs.
5) Patients who suffer from systemic pain, rheumatoid arthritis,
fibromyalgia, tumor or infection in the spinal cord and intervertebral disc, and other diseases inducing the systemic pain.
6) Patient with neck or low back pain due to heart diseases.
7) Pregnant subjects.
8) The presence of malignant tumor, or the past history of the malignant tumor.
9) Patients with psychiatric disorders.
10) Patients with severe osteoporosis.
11) Patients who complain weight loss and fever of unknown cause.
12) Patients who received treatments such as massage, acupuncture, never block, etc, for their back pain at other hospitals or clinics within 1 month from the start of the study.
13) Patients with a history of whiplash injury due to traffic accidents.
14) Patients whom are recognized as inadequate subjects by the experimenters.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouich Takamoto
Organization University of Toyama
Division name Department of Judo Neurophysiotherapy
Zip code
Address 2630,Sugitani, Toyama, Japan
TEL 007-434-7218
Email ktakamo@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kouich Takamoto
Organization University of Toyama
Division name Department of Judo Neurophysiotherapy
Zip code
Address 2630,Sugitani, Toyama, Japan
TEL 076-434-7218
Homepage URL
Email ktakamo@med.u-toyama.ac.jp

Sponsor
Institute Department of
Judo Neurophysiotherapy, Graduate school of medicine and pharmaceutical science, University of Toyama
Institute
Department

Funding Source
Organization Japan Judo Therapist Association
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2011 Year 03 Month 28 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
2011 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2013 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 28 Day
Last modified on
2016 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006336

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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