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CompletedNCT01241071Updated Aug 8, 2017

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

An interventional study of myofascial treatment and Placebo in Low Back Pain, Disability and Motor Activity, sponsored by Cardenal Herrera University. Completed at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-08-08.

Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Low Back Pain
  • Disability
  • Motor Activity
  • Range of Motion

Keywords

  • Lumbar region
  • Pain
  • Fascia
  • Electromyography
  • Goniometry
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 54 is close to the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Cardenal Herrera University is the lead sponsor of 104 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • low back pain for more than 3 months

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Myofascial treatment

    Myofascial release techniques of different muscles implicated in low back pain

    Other: myofascial treatment

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • Othermyofascial treatment

    myofascial release techniques of different muscles implicated in low back pain

  • OtherPlacebo

    A manual sham intervention will be applied to different muscles implicated in low back pain

06

What researchers measure

Primary outcomes

  1. Lumbar Pain

    Short Form McGill Pain Questionnaire. Visual Analogical Scale

    Time frame: 3 weeks

Secondary outcomes

  1. Disability

    Roland Morris Disability Questionnaire

    Time frame: 3 weeks

  2. Fear Avoidance Beliefs

    Fear Avoidance Beliefs Questionnaire

    Time frame: 3 weeks

  3. EMG Erector Spinae

    Electromyography record (MEGAWIN 6000)

    Time frame: 3 weeks

  4. Lumbar ROM

    Electrogonyometry Fastrak (Polhemus)

    Time frame: 3 weeks

07

Study locations

1 site
  • CEU Cardenal Herrera University
    Moncada, Valencia 46113, Spain
08

References and documents

Publications

  • 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. PubMed 14795792 ↗
  • 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. PubMed 19851155 ↗
  • 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. PubMed 19083673 ↗
  • 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. PubMed 18724827 ↗
  • 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. PubMed 15922099 ↗
  • 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. PubMed 19539117 ↗
  • 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. PubMed 17224353 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01241071
Lead sponsor
Cardenal Herrera University
Collaborators
Hospital Arnau de Vilanova
Responsible party
Eva Segura Ortí (PhD, Cardenal Herrera University) — Principal investigator
First posted
Nov 16, 2010
Start date
Jan 2011
Primary completion
Dec 2012
Completion
Mar 2013
Last update
Aug 8, 2017

Study contacts

Javier Romero, Dean
study director · Health Science Faculty CEU-UCH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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