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Lumbar Segmental Stabilization and TENS in Lumbar Disc Herniation

Primary Purpose

Lumbar Spine Disc Herniation

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Lumbar stabilization exercises
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spine Disc Herniation focused on measuring lumbar disc herniation, clinical trial, exercise therapy, TENS

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Sao Paulo General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lumbar stabilization exercises

TENS group

Arm Description

In the Segmental Stabilization group exercises the focus is on the transversus abdominis and lumbar multifidus muscles.

In this group, patients are treated with TENS in the lumbar region for an hour.

Outcomes

Primary Outcome Measures

Pain.
The pain will be assessed with the visual analogical scale and McGill pain questionnaire.

Secondary Outcome Measures

Full Information

First Posted
July 3, 2012
Last Updated
July 12, 2012
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01640431
Brief Title
Lumbar Segmental Stabilization and TENS in Lumbar Disc Herniation
Official Title
Lumbar Segmental Stabilization and TENS in Lumbar Disc Herniation: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Disc Herniation
Keywords
lumbar disc herniation, clinical trial, exercise therapy, TENS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumbar stabilization exercises
Arm Type
Experimental
Arm Description
In the Segmental Stabilization group exercises the focus is on the transversus abdominis and lumbar multifidus muscles.
Arm Title
TENS group
Arm Type
Experimental
Arm Description
In this group, patients are treated with TENS in the lumbar region for an hour.
Intervention Type
Other
Intervention Name(s)
Lumbar stabilization exercises
Intervention Description
The patients performed exercises for the transversus abdominis and lumbar multifidus muscles for an hour twice a week.
Primary Outcome Measure Information:
Title
Pain.
Description
The pain will be assessed with the visual analogical scale and McGill pain questionnaire.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luiz V Ramos, PT
Phone
55 11 30918423
Email
luiz.armando@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Amelia P Marques, PhD
Phone
55 11 30918423
Email
pasqual@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio R França, MsC
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fábio R França, MsC
Phone
55 11 30918423
Email
fabiojrf@usp.br
First Name & Middle Initial & Last Name & Degree
Luiz V Ramos, MsC
Phone
55 11 85674888
Email
luiz.armando@usp.br
First Name & Middle Initial & Last Name & Degree
Fabio R França, MsC

12. IPD Sharing Statement

Citations:
PubMed Identifier
16894798
Citation
Rackwitz B, de Bie R, Limm H, von Garnier K, Ewert T, Stucki G. Segmental stabilizing exercises and low back pain. What is the evidence? A systematic review of randomized controlled trials. Clin Rehabil. 2006 Jul;20(7):553-67. doi: 10.1191/0269215506cr977oa.
Results Reference
background
PubMed Identifier
30247159
Citation
Franca FJR, Callegari B, Ramos LAV, Burke TN, Magalhaes MO, Comachio J, CarvalhoSilva APMC, Almeida GPL, Marques AP. Motor Control Training Compared With Transcutaneous Electrical Nerve Stimulation in Patients With Disc Herniation With Associated Radiculopathy: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2019 Mar;98(3):207-214. doi: 10.1097/PHM.0000000000001048.
Results Reference
derived

Learn more about this trial

Lumbar Segmental Stabilization and TENS in Lumbar Disc Herniation

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