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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
  Purpose

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.


Condition Intervention
Low Back Pain
Disability
Motor Activity
Range of Motion
Other: myofascial treatment
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of a Myofascial Release Protocol on Pain, Disability and Activation Pattern of Erector Spinae in Patients With Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Cardenal Herrera University:

Primary Outcome Measures:
  • Lumbar Pain [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Short Form McGill Pain Questionnaire. Visual Analogical Scale


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Myofascial treatment
Myofascial release techniques of different muscles implicated in low back pain
Other: myofascial treatment
myofascial release techniques of different muscles implicated in low back pain
Placebo Comparator: Placebo Other: Placebo
A manual sham intervention will be applied to different muscles implicated in low back pain

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241071

Contacts
Contact: Mª Dolores Arguisuelas Martínez, Professor 0034961369000 ext 1225 doloresarguisuelas@uch.ceu.es

Locations
Spain
CEU Cardenal Herrera University Not yet recruiting
Moncada, Valencia, Spain, 46113
Contact: Mª Dolores Arguisuelas Martínez, Professor    0034961369000 ext 1225    doloresarguisuelas@uch.ceu.es   
Sponsors and Collaborators
Cardenal Herrera University
Hospital Arnau de Vilanova
Investigators
Study Director: Javier Romero, Dean Health Science Faculty CEU-UCH
  More Information

Additional Information:
Publications:

Responsible Party: Mª Dolores Arguisuelas Martínez/Physical Therapy Professor, CEU- Cardenal Herrera
ClinicalTrials.gov Identifier: NCT01241071     History of Changes
Other Study ID Numbers: CEU-UCH-88
Study First Received: November 15, 2010
Last Updated: November 15, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by Cardenal Herrera University:
Lumbar region
Pain
Fascia
Electromyography
Goniometry

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014