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Lumbar Segmental Stabilization and TENS in Lumbar Disc Herniation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01640431
First Posted: July 13, 2012
Last Update Posted: July 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
  Purpose
The purpose of this study was to compare the efficacy of method Lumbar Segmental Stabilization and transcutaneous electrical nerve stimulation (TENS) on pain, functional disability and ability to activate the transversus abdominis (TrA) of individuals with chronic back pain caused by disc herniation.

Condition Intervention
Lumbar Spine Disc Herniation Other: Lumbar stabilization exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Lumbar Segmental Stabilization and TENS in Lumbar Disc Herniation: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Pain. [ Time Frame: 8 weeks ]
    The pain will be assessed with the visual analogical scale and McGill pain questionnaire.


Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: July 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lumbar stabilization exercises
In the Segmental Stabilization group exercises the focus is on the transversus abdominis and lumbar multifidus muscles.
Other: Lumbar stabilization exercises
The patients performed exercises for the transversus abdominis and lumbar multifidus muscles for an hour twice a week.
Experimental: TENS group
In this group, patients are treated with TENS in the lumbar region for an hour.
Other: Lumbar stabilization exercises
The patients performed exercises for the transversus abdominis and lumbar multifidus muscles for an hour twice a week.

Detailed Description:

Objective: To contrast the efficacy efficacy of method Lumbar Segmental Stabilization and TENS on pain, functional capacity and ability to activate the TrA of individuals with chronic back pain caused by disc herniation.

Design: Sixty patients are being randomized into two groups namely: Lumbar Segmental Stabilization (LS ) (specific exercises for the muscles transversus abdominis and lumbar multifidus) (n = 30) and TENS group (TG) (n = 30) receiving assistance under a current of transcutaneous electrical nerve stimulation (TENS). Groups were contrasted regarding pain (visual analogical scale and McGill pain questionnaire), functional disability (Oswestry disability questionnaire) and TrA muscle activation capacity (Pressure Biofeedback Unit = PBU). The program lasts for 8 weeks, and sessions happen twice a week, with duration of one hour each. Evaluations will be performed before, after and with a follow-up six months after treatment. Significance level is established at 5%.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic low back pain (pain for more than three months) or sciatica caused by disc herniation diagnosed by magnetic resonance imaging or computed tomography

Exclusion Criteria:

  • prior back surgery,
  • cancer,
  • rheumatic diseases or infection.

Patients involved in sports or resistance training for the lumbar spine during the three months prior to the beginning of treatment or other causes of pain and sciatica such as lumbar spinal canal stenosis and lumbar spondylolisthesis have also been excluded.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640431


Contacts
Contact: Luiz V Ramos, PT 55 11 30918423 luiz.armando@usp.br
Contact: Amelia P Marques, PhD 55 11 30918423 pasqual@usp.br

Locations
Brazil
University of Sao Paulo General Hospital Recruiting
Sao Paulo, Brazil
Contact: Fábio R França, MsC    55 11 30918423    fabiojrf@usp.br   
Contact: Luiz V Ramos, MsC    55 11 85674888    luiz.armando@usp.br   
Principal Investigator: Fabio R França, MsC         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Fabio R França, MsC University of Sao Paulo
  More Information

Publications:
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01640431     History of Changes
Other Study ID Numbers: Fisio2011
First Submitted: July 3, 2012
First Posted: July 13, 2012
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by University of Sao Paulo General Hospital:
lumbar disc herniation
clinical trial
exercise therapy
TENS

Additional relevant MeSH terms:
Hernia
Intervertebral Disc Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases


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