Low Back PainPhase 4NCT02427425
Effectiveness of Transcutaneous Electrical Nerve Stimulation in Patients With Acute Low Back Pain
A Phase 4 study testing TENS in people with Low Back Pain, run by Federal University of São Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
- Being tested
- TENS
- Keywords
- Transcutaneous Electric Nerve Stimulation, Pain
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
| Study group | Role | What they receive |
|---|---|---|
| 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 '. Receives: Device: TENS |
| Placebo group | Placebo comparator | In Placebo group the same procedures of the TENS group were adopted, but did not occur electrical stimulus. Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain assessed by visual analog scale
Measured: 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
Measured: Baseline; 10; 30 and 60 days
Change in self-assessment of improvement assessed by a likert scale
Measured: Baseline; 10; 30 and 60 days
Change in Quality of life assessed by the SF-36 questionnaire
Measured: Baseline; 10; 30 and 60 days
Change in Drug consumption assessed by the number of NSAIDs consumed
Measured: Baseline; 10; 30 and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startJun 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vaneska da Graça Cruz Martinelli Lourenzi, Federal University of São Paulo
- Investigators
- Vaneska GC Lourenzi, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427425
- Sponsor's protocol ID
- CEP 1308/09
- Status last verified
- Apr 2015
- First submitted
- 10 Mar 2015
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcutaneous Electrical Nerve Stimulation in Patients With Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT02427425
- Acronym / sponsor ID
- CEP 1308/09
- Conditions
- Low Back Pain
- Keywords
- Transcutaneous Electric Nerve Stimulation, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS group | Experimental | Device: TENSIt 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 '. |
| Placebo group | Placebo comparator | Device: TENSIn Placebo group the same procedures of the TENS group were adopted, but did not occur electrical stimulus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENS | Device | Placebo group, TENS group |
Primary outcome
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
4 secondary outcomes
Change in functional capacity assessed by the Roland Morris questionnaire
Time frame: Baseline; 10; 30 and 60 days
Change in self-assessment of improvement assessed by a likert scale
Time frame: Baseline; 10; 30 and 60 days
Change in Quality of life assessed by the SF-36 questionnaire
Time frame: Baseline; 10; 30 and 60 days
Change in Drug consumption assessed by the number of NSAIDs consumed
Time frame: Baseline; 10; 30 and 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vaneska GC Lourenzi principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TENS in people with Low Back Pain, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.