Effectiveness of Transcutaneous Electrical Nerve Stimulation in Patients With Acute Low Back Pain

NCT ID: NCT02427425

Last Updated: 2015-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-05-31

Brief Summary

Introduction: Low back pain is one of the most common complaints in doctors' offices, and acute low back pain is characterized by episodes of pain with less than three weeks duration. The transcutaneous electrical nerve stimulation (TENS), based on the gate control theory of pain proposed by Melzack and Wall in 1965, has been used as an adjunctive therapy in the control of back pain, being a non-invasive, low cost, safe and easy to apply. No studies were found regarding the effectiveness of TENS in acute low back pain.

Objective: To evaluate the effectiveness of TENS in pain management of patients with acute low back pain.

Material and Methods: A randomized clinical trial, double-blinded and placebo-controlled. Patients were selected in the clinics of Federal de University of Sao Paulo (UNIFESP) according to the following criteria: acute low back pain, both genders, aged between 18 and 65 years, pain between 4 and 8cm in pain numeric scale (PNS) and who agreed to participate in the study. After signing the informed consent patients were randomly allocated into one of the groups: TENS group (TG) or Placebo Group (PG). In TG was applied conventional TENS with frequency and intensity variation (FIV) effect, frequency of 100 hertz, a pulse width of 60μs and intensity adjusted according to the individual baseline for each patient without causing muscular contraction. The electrodes were arranged in a cross shape in the paravertebral region (levels T12-L1 and L5 - S1). In PG the same procedures were adopted, but did not occur electrical stimulus. Patients were informed that they could or could not feel electric shocks. Treatment consisted of 10 sessions (2x / week / 5 weeks), with each session lasting 30 '. Assessments were made at the following times: T0 (baseline), T1 to T10 (the beginning and end of each session), T11 (after the last session), T30 (30 days after the last session) and T60 (60 days after the last session). Assessment tools: PNS for pain, short-form 36 (SF-36), Roland-Morris, self-assessment of improvement ("Likert" scale) and drug consumption (daily).

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TENS group

It was applied conventional TENS with FIV effect, frequency of 100 Hertz, a pulse width of 60μs and intensity adjusted according to the individual baseline for each patient without causing muscular contraction. The electrodes were arranged in a cross shape in the paravertebral region (levels T12-L1 and L5 - S1). Treatment consisted of 10 sessions (2x / week / 5 weeks), with each session lasting 30 '.

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

Placebo group

In Placebo group the same procedures of the TENS group were adopted, but did not occur electrical stimulus.

Group Type: PLACEBO_COMPARATOR

TENS

Intervention Type: DEVICE

Interventions

TENS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• acute low back pain
• both genders
• aged between 18 and 65 years
• pain between 4 and 8cm in PNS (pain numeric scale)
• who agreed to participate in the study.

Exclusion Criteria

• Patients with pain of inflammatory, neoplastic or infectious origin,
• with cardiac pacemaker,
• previous back surgery,
• signs of irritation of nerve roots,
• vertebral fracture, which changed the physical activity in the last three months,
• and pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Vaneska da Graça Cruz Martinelli Lourenzi

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vaneska GC Lourenzi

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Other Identifiers

CEP 1308/09

Identifier Type: -

Identifier Source: org_study_id