Effectiveness of Transcutaneous Electrical Nerve Stimulation in Patients With Acute Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
TENS
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Transcutaneous Electric Nerve Stimulation, Pain
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TENS group
Placebo group
Arm Description
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 '.
In Placebo group the same procedures of the TENS group were adopted, but did not occur electrical stimulus.
Outcomes
Primary Outcome Measures
Change in pain assessed by visual analog scale
Secondary Outcome Measures
Change in functional capacity assessed by the Roland Morris questionnaire
Change in self-assessment of improvement assessed by a likert scale
Change in Quality of life assessed by the SF-36 questionnaire
Change in Drug consumption assessed by the number of NSAIDs consumed
Full Information
NCT ID
NCT02427425
First Posted
March 10, 2015
Last Updated
April 22, 2015
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02427425
Brief Title
Effectiveness of Transcutaneous Electrical Nerve Stimulation in Patients With Acute Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Transcutaneous Electric Nerve Stimulation, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TENS group
Arm Type
Experimental
Arm Description
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 '.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
In Placebo group the same procedures of the TENS group were adopted, but did not occur electrical stimulus.
Intervention Type
Device
Intervention Name(s)
TENS
Primary Outcome Measure Information:
Title
Change in pain assessed by visual analog scale
Time Frame
Baseline; 1,2,3,4,5,6,7,8,9,10; 30 and 60 days
Secondary Outcome Measure Information:
Title
Change in functional capacity assessed by the Roland Morris questionnaire
Time Frame
Baseline; 10; 30 and 60 days
Title
Change in self-assessment of improvement assessed by a likert scale
Time Frame
Baseline; 10; 30 and 60 days
Title
Change in Quality of life assessed by the SF-36 questionnaire
Time Frame
Baseline; 10; 30 and 60 days
Title
Change in Drug consumption assessed by the number of NSAIDs consumed
Time Frame
Baseline; 10; 30 and 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vaneska GC Lourenzi
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Effectiveness of Transcutaneous Electrical Nerve Stimulation in Patients With Acute Low Back Pain
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