NCT01241071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

November 15, 2010

Last Update Submit

August 7, 2017

Conditions

Keywords

Lumbar regionPainFasciaElectromyographyGoniometry

Outcome Measures

Primary Outcomes (1)

  • Lumbar Pain

    Short Form McGill Pain Questionnaire. Visual Analogical Scale

    3 weeks

Secondary Outcomes (4)

  • Disability

    3 weeks

  • Fear Avoidance Beliefs

    3 weeks

  • EMG Erector Spinae

    3 weeks

  • Lumbar ROM

    3 weeks

Study Arms (2)

Myofascial treatment

EXPERIMENTAL

Myofascial release techniques of different muscles implicated in low back pain

Other: myofascial treatment

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

myofascial release techniques of different muscles implicated in low back pain

Myofascial treatment
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • low back pain for more than 3 months

You may not qualify if:

  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEU Cardenal Herrera University

Moncada, Valencia, 46113, Spain

Location

Related Publications (7)

  • 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.

    PMID: 14795792BACKGROUND
  • 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.

    PMID: 19851155BACKGROUND
  • 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.

    PMID: 19083673BACKGROUND
  • 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.

    PMID: 18724827BACKGROUND
  • 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.

    PMID: 15922099BACKGROUND
  • 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.

    PMID: 19539117BACKGROUND
  • 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.

    PMID: 17224353BACKGROUND

Related Links

MeSH Terms

Conditions

Low Back PainMotor ActivityPain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Javier Romero, Dean

    Health Science Faculty CEU-UCH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 16, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations