Clinical trial NCT01640431: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spine Disc Herniation
Keywords: lumbar disc herniation
clinical trial
exercise therapy
TENS
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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.

Primary outcomes:
measure: Pain.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
Study officials:
affiliation: University of Sao Paulo
name: Fabio R França, MsC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.