Lumbar Segmental Stabilization and TENS in Lumbar Disc Herniation

Not Applicable

• Conditions: Lumbar Spine Disc Herniation
• Interventions: Other: Lumbar stabilization exercises

• Registration Number: NCT01640431
• Lead Sponsor: University of Sao Paulo General Hospital

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%.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-08
• Status Verified: 2012-07
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-12
• Last Update Submitted: 2012-07-12
• Study First Posted: 2012-07-13
• Last Update Posted: 2012-07-13
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar stabilization exercises	Lumbar stabilization exercises	In the Segmental Stabilization group exercises the focus is on the transversus abdominis and lumbar multifidus muscles.
TENS group	Lumbar stabilization exercises	In this group, patients are treated with TENS in the lumbar region for an hour.

Primary Outcome Measures

Name	Time	Method
Pain.	8 weeks	The pain will be assessed with the visual analogical scale and McGill pain questionnaire.

Trial Locations

Locations (1)

University of Sao Paulo General Hospital; 🇧🇷 Sao Paulo, Brazil