UMIN-CTR Clinical Trial

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

Acute-subacute neck or low back pain

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Japan Judo Therapist Association

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

03

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

03

Month

28

Day

Last modified on

2016

Year

01

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006336