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

NCT02427425 | Completed Phase 4 DMC

• 1 other identifier: CEP 1308/09
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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

Keywords

Transcutaneous Electric Nerve Stimulation; Pain

Outcome Measures

Primary Outcomes (1)

• Change in pain assessed by visual analog scale

  Baseline; 1,2,3,4,5,6,7,8,9,10; 30 and 60 days

Secondary Outcomes (4)

• Change in functional capacity assessed by the Roland Morris questionnaire

  Baseline; 10; 30 and 60 days

• Change in self-assessment of improvement assessed by a likert scale

  Baseline; 10; 30 and 60 days

• Change in Quality of life assessed by the SF-36 questionnaire

  Baseline; 10; 30 and 60 days

• Change in Drug consumption assessed by the number of NSAIDs consumed

  Baseline; 10; 30 and 60 days

Study Arms (2)

TENS group

EXPERIMENTAL

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 '.

Device: TENS

Placebo group

PLACEBO COMPARATOR

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

Device: TENS

Interventions

TENS DEVICE

Placebo group; TENS group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

MeSH Terms

Conditions

Low Back Pain; Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Vaneska GC Lourenzi

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: April 28, 2015
• Study Start: June 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 28, 2015

Record last verified: 2015-04