Low Back Pain Clinical Trial
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).
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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