Lumbar Segmental Stabilization and TENS in Lumbar Disc Herniation

NCT01640431 | Unknown DMC

• 1 other identifier: Fisio2011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spine Disc Herniation

Keywords

lumbar disc herniation; clinical trial; exercise therapy; TENS

Outcome Measures

Primary Outcomes (1)

• Pain.

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

  8 weeks

Study Arms (2)

Lumbar stabilization exercises

EXPERIMENTAL

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

Other: Lumbar stabilization exercises

TENS group

EXPERIMENTAL

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

Other: Lumbar stabilization exercises

Interventions

Lumbar stabilization exercises OTHER

The patients performed exercises for the transversus abdominis and lumbar multifidus muscles for an hour twice a week.

Lumbar stabilization exercises; TENS group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 16894798 BACKGROUND

• 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.

  PMID: 30247159 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabio R França, MsC

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luiz V Ramos, PT

CONTACT

55 11 30918423; luiz.armando@usp.br

Amelia P Marques, PhD

CONTACT

55 11 30918423; pasqual@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 13, 2012
• Study Start: March 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: July 1, 2013
• Last Updated: July 13, 2012

Record last verified: 2012-07

Locations

BR (1)