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

Primary Purpose

Low Back Pain, Disability, Motor Activity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
myofascial treatment
Placebo
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Lumbar region, Pain, Fascia, Electromyography, Goniometry

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CEU Cardenal Herrera University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Myofascial treatment

Placebo

Arm Description

Myofascial release techniques of different muscles implicated in low back pain

Outcomes

Primary Outcome Measures

Lumbar Pain
Short Form McGill Pain Questionnaire. Visual Analogical Scale

Secondary Outcome Measures

Disability
Roland Morris Disability Questionnaire
Fear Avoidance Beliefs
Fear Avoidance Beliefs Questionnaire
EMG Erector Spinae
Electromyography record (MEGAWIN 6000)
Lumbar ROM
Electrogonyometry Fastrak (Polhemus)

Full Information

First Posted
November 15, 2010
Last Updated
August 7, 2017
Sponsor
Cardenal Herrera University
Collaborators
Hospital Arnau de Vilanova
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1. Study Identification

Unique Protocol Identification Number
NCT01241071
Brief Title
Effects of Myofascial Release on Pain, Disability and Electromyography of Erector Spinae in Chronic Low Back Pain
Official Title
Effects of a Myofascial Release Protocol on Pain, Disability and Activation Pattern of Erector Spinae in Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
Collaborators
Hospital Arnau de Vilanova

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Disability, Motor Activity, Range of Motion
Keywords
Lumbar region, Pain, Fascia, Electromyography, Goniometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myofascial treatment
Arm Type
Experimental
Arm Description
Myofascial release techniques of different muscles implicated in low back pain
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
myofascial treatment
Intervention Description
myofascial release techniques of different muscles implicated in low back pain
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A manual sham intervention will be applied to different muscles implicated in low back pain
Primary Outcome Measure Information:
Title
Lumbar Pain
Description
Short Form McGill Pain Questionnaire. Visual Analogical Scale
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Disability
Description
Roland Morris Disability Questionnaire
Time Frame
3 weeks
Title
Fear Avoidance Beliefs
Description
Fear Avoidance Beliefs Questionnaire
Time Frame
3 weeks
Title
EMG Erector Spinae
Description
Electromyography record (MEGAWIN 6000)
Time Frame
3 weeks
Title
Lumbar ROM
Description
Electrogonyometry Fastrak (Polhemus)
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Romero, Dean
Organizational Affiliation
Health Science Faculty CEU-UCH
Official's Role
Study Director
Facility Information:
Facility Name
CEU Cardenal Herrera University
City
Moncada
State/Province
Valencia
ZIP/Postal Code
46113
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
14795792
Citation
FLOYD WF, SILVER PH. Function of erectores spinae in flexion of the trunk. Lancet. 1951 Jan 20;1(6647):133-4. doi: 10.1016/s0140-6736(51)91212-3. No abstract available.
Results Reference
background
PubMed Identifier
19851155
Citation
Alschuler KN, Neblett R, Wiggert E, Haig AJ, Geisser ME. Flexion-relaxation and clinical features associated with chronic low back pain: A comparison of different methods of quantifying flexion-relaxation. Clin J Pain. 2009 Nov-Dec;25(9):760-6. doi: 10.1097/AJP.0b013e3181b56db6.
Results Reference
background
PubMed Identifier
19083673
Citation
Grinnell F. Fibroblast mechanics in three-dimensional collagen matrices. J Bodyw Mov Ther. 2008 Jul;12(3):191-3. doi: 10.1016/j.jbmt.2008.03.005. Epub 2008 May 23.
Results Reference
background
PubMed Identifier
18724827
Citation
Fernandez-Perez AM, Peralta-Ramirez MI, Pilat A, Villaverde C. Effects of myofascial induction techniques on physiologic and psychologic parameters: a randomized controlled trial. J Altern Complement Med. 2008 Sep;14(7):807-11. doi: 10.1089/acm.2008.0117.
Results Reference
background
PubMed Identifier
15922099
Citation
Schleip R, Klingler W, Lehmann-Horn F. Active fascial contractility: Fascia may be able to contract in a smooth muscle-like manner and thereby influence musculoskeletal dynamics. Med Hypotheses. 2005;65(2):273-7. doi: 10.1016/j.mehy.2005.03.005.
Results Reference
background
PubMed Identifier
19539117
Citation
Saiz-Llamosas JR, Fernandez-Perez AM, Fajardo-Rodriguez MF, Pilat A, Valenza-Demet G, Fernandez-de-Las-Penas C. Changes in neck mobility and pressure pain threshold levels following a cervical myofascial induction technique in pain-free healthy subjects. J Manipulative Physiol Ther. 2009 Jun;32(5):352-7. doi: 10.1016/j.jmpt.2009.04.009.
Results Reference
background
PubMed Identifier
17224353
Citation
Ritvanen T, Zaproudina N, Nissen M, Leinonen V, Hanninen O. Dynamic surface electromyographic responses in chronic low back pain treated by traditional bone setting and conventional physical therapy. J Manipulative Physiol Ther. 2007 Jan;30(1):31-7. doi: 10.1016/j.jmpt.2006.11.010. Erratum In: J Manipulative Physiol Ther. 2007 Jul-Aug;30(6):472.
Results Reference
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Links:
URL
http://www.uchceu.es
Description
CEU Cardenal Herrera University is the first private university in the Valencian Community. It belongs to the San Pablo CEU Foundation which is a leading educational organization in Spain with three universities all over Spain.

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

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