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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01241071
Other study ID # CEU-UCH-88
Secondary ID
Status Completed
Phase N/A
First received November 15, 2010
Last updated August 7, 2017
Start date January 2011
Est. completion date March 2013

Study information

Verified date August 2017
Source Cardenal Herrera University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date March 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Spain CEU Cardenal Herrera University Moncada Valencia

Sponsors (2)

Lead Sponsor Collaborator
Cardenal Herrera University Hospital Arnau de Vilanova

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

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. — View Citation

FLOYD WF, SILVER PH. Function of erectores spinae in flexion of the trunk. Lancet. 1951 Jan 20;1(6647):133-4. — View 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. Review. — View Citation

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. — View Citation

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Lumbar Pain Short Form McGill Pain Questionnaire. Visual Analogical Scale 3 weeks
Secondary Disability Roland Morris Disability Questionnaire 3 weeks
Secondary Fear Avoidance Beliefs Fear Avoidance Beliefs Questionnaire 3 weeks
Secondary EMG Erector Spinae Electromyography record (MEGAWIN 6000) 3 weeks
Secondary Lumbar ROM Electrogonyometry Fastrak (Polhemus) 3 weeks
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