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

• Sponsor: Cardenal Herrera University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01241071
• Collaborator: Hospital Arnau de Vilanova (Other)
• Enrollment: 54
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain; Disability; Motor Activity; Range of Motion	Other: myofascial treatment; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Lumbar Pain [3 weeks]

   Short Form McGill Pain Questionnaire. Visual Analogical Scale

Secondary Outcome Measures

1. Disability [3 weeks]

   Roland Morris Disability Questionnaire

2. Fear Avoidance Beliefs [3 weeks]

   Fear Avoidance Beliefs Questionnaire

3. EMG Erector Spinae [3 weeks]

   Electromyography record (MEGAWIN 6000)

4. Lumbar ROM [3 weeks]

   Electrogonyometry Fastrak (Polhemus)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	CEU Cardenal Herrera University	Moncada	Valencia	Spain	46113

Sponsors and Collaborators

• Cardenal Herrera University
• Hospital Arnau de Vilanova

Investigators

• Study Director: Javier Romero, Dean, Health Science Faculty CEU-UCH

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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.

Publications

• 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.
• Fernández-Pérez AM, Peralta-Ramírez 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.
• FLOYD WF, SILVER PH. Function of erectores spinae in flexion of the trunk. Lancet. 1951 Jan 20;1(6647):133-4.
• 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. Review.
• Ritvanen T, Zaproudina N, Nissen M, Leinonen V, Hänninen 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. Erratum in: J Manipulative Physiol Ther. 2007 Jul-Aug;30(6):472.
• Saíz-Llamosas JR, Fernández-Pérez AM, Fajardo-Rodríguez MF, Pilat A, Valenza-Demet G, Fernández-de-Las-Peñas 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.
• 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.

• Responsible Party: Eva Segura Ortí, PhD, Cardenal Herrera University
• ClinicalTrials.gov Identifier: NCT01241071
• Other Study ID Numbers: CEU-UCH-88
• First Posted: Nov 16, 2010
• Last Update Posted: Aug 8, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Eva Segura Ortí, PhD, Cardenal Herrera University: Lumbar region; Pain; Fascia; Electromyography; Goniometry
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Aug 8, 2017