Effects of Myofascial Release on Pain, Disability and Electromyography of Erector Spinae in Chronic Low Back Pain

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2010 by Cardenal Herrera University.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Hospital Arnau de Vilanova

Information provided by:

Cardenal Herrera University

ClinicalTrials.gov Identifier:

NCT01241071

First received: November 15, 2010

Last updated: NA

Last verified: November 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 15, 2010

Last Updated Date

November 15, 2010

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Lumbar Pain [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Short Form McGill Pain Questionnaire. Visual Analogical Scale

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Disability [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Roland Morris Disability Questionnaire
Fear Avoidance Beliefs [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Fear Avoidance Beliefs Questionnaire
EMG Erector Spinae [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Electromyography record (MEGAWIN 6000)
Lumbar ROM [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Electrogonyometry Fastrak (Polhemus)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Myofascial Release on Pain, Disability and Electromyography of Erector Spinae in Chronic Low Back Pain

Official Title ^ICMJE

Effects of a Myofascial Release Protocol on Pain, Disability and Activation Pattern of Erector Spinae in Patients With Chronic Low Back Pain

Brief Summary

The purpose of this study is to determine whether myofascial release techniques are effective in the improvement of pain, disability and electromyography response of lumbar muscles in patients with chronic low back pain.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Low Back Pain
Disability
Motor Activity
Range of Motion

Intervention ^ICMJE

Other: myofascial treatment
myofascial release techniques of different muscles implicated in low back pain
Other: Placebo
A manual sham intervention will be applied to different muscles implicated in low back pain

Study Arm (s)

Experimental: Myofascial treatment
Myofascial release techniques of different muscles implicated in low back pain

Intervention: Other: myofascial treatment
Placebo Comparator: Placebo
Intervention: Other: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2012

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

low back pain for more than 3 months

Exclusion Criteria:

vertebra fractures
systemic disease (spondylitis, neoplasia, infectious, vascular, endocrine or metabolic disorders)
spinal surgery
advanced lumbar instability
osteoporosis (in advanced stage)
degenerative articular disease
acute soft tissue inflammation
rheumatoid arthritis
osteomyelitis
neuromuscular disease
lower limb musculoskeletal injuries
radiculopathy
cauda equine syndrome
myelopathy
stenosis
structural spine deformity (kyphoscoliosis...)
pregnancy
abundant menstruation
IUD carrier
mental disease
dermatologic disease
skin sensitivity
aneurysma
corticosteroids treatment
anticoagulant therapy
hypertension
diabetes
hemophilia
leucemia
rejection to manual contact

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mª Dolores Arguisuelas Martínez, Professor

0034961369000 ext 1225

doloresarguisuelas@uch.ceu.es

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01241071

Other Study ID Numbers ^ICMJE

CEU-UCH-88

Has Data Monitoring Committee

Responsible Party

Mª Dolores Arguisuelas Martínez/Physical Therapy Professor, CEU- Cardenal Herrera

Study Sponsor ^ICMJE

Cardenal Herrera University

Collaborators ^ICMJE

Hospital Arnau de Vilanova

Investigators ^ICMJE

Study Director:

Javier Romero, Dean

Health Science Faculty CEU-UCH

Information Provided By

Cardenal Herrera University

Verification Date

November 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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