Chronic Low Back PainNCT01017913
Transcutaneous Electrical Nerve Stimulation and Interferential Currents in Chronic Low Back Pain
A study testing TENS and Interferential currents in people with Chronic Low Back Pain, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study was to compare the effects of the TENS and IFC in patients with non specific chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- TENS and Interferential currents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2006to Dec 2007
- Phase
- Interventional
- 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
- Individuals who had had low back pain for less than three months
Who cannot join
- Individuals who were receiving treatment for their pain with another method at the same time, except for medicines;
- Pregnant women;
- Patients who had undergone vertebral column surgery (less than three months before the time of this study);
- Individuals with contraindications against electrotherapy, such as skin lesions, abnormal sensitivity, infectious and blood diseases, heart pacemakers or inability to answer questionnaires;
- Patients with fibromyalgia;
- Individuals with psychiatric problems;
- Individuals who refused to participate or were unwilling to follow a protocol lasting for two weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Currents (IFC) in Patients With Non Specific Chronic Low Back Pain: Randomized Clinical Trial
The purpose of this study was to compare the effects of the TENS and IFC in patients with non specific chronic low back pain.
Read the detailed description
Setting Outpatient physiotherapy department in university (Cesumar)
Participants A hundred and fifty patients with non specific chronic low back pain with or without radicular pain.
Interventions The patients were randomly divided into three groups: 1) TENS; 2) IFC; e 3) Control. Ten sessions of electrotherapy for groups 1 and 2, while the patients of the Control group stayed without any treatment in the same period
Main Outcome Measures Intensity of the pain through the Visual Analogue Scale and McGill Pain Questionnaire; specific functional disability by Roland Morris Disability Questionnaire; Analgesic period (hours); and the medication consumption
Statistic Analysis All data were analyzed using Statistica version 7 and SAS version 9.1. Baseline characteristics were compared using the Shapiro-Wilks test for continuous variables and then analysis of variance for measuring independent data. The characteristics of the patients who finished the treatment were compared with those of the lost patients, using one-way ANOVA and the Kruskal-Wallis test.
- Conditions
- Chronic Low Back Pain
- Being tested
- TENS, Interferential currents
- Keywords
- rehabilitation, electrotherapy, back pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSOther
Also called Transcutaneous electrical nervous stimulation
The TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms (standing in control number seven) with two channels.
Interferential currentsOther
Also called IFC: intereferential currents, electrotherapy
The IFC was adjusted to a base frequency of 4000 Hz, with a modulation frequency range of 20 Hz, ∆F of 10 Hz and slope of 1/1, in quadripolar mode.
| Study group | Role | What they receive |
|---|---|---|
| Electrotherapy equipment | Active comparator | The TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms with two channels. Receives: Other: TENS; Other: Interferential currents |
| electrotherapy equipment | Active comparator | The CI was adjusted with 4000 HZ bases frequency, modulation frequency range 20 HZ, ∆F10 HZ, slope 1/1 and quadripolar manner. Receives: Other: TENS; Other: Interferential currents |
| Control | No intervention | The patients of the Control group stayed without any treatment in the same period Receives: Other: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and Disability
Measured: Before and after ten sessions (interventions groups) or ten days (control group)
Secondary outcomes (1)
Analgesic period (hours)and medication consumption
Measured: before and after ten sessions (interventions groups) or ten days (control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startMar 2006
- Primary completionDec 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Universitario de Maringa
- Investigators
- Ligia M Facci, Principal investigator, Unifesp/ Cesumar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017913
- Sponsor's protocol ID
- 0143/06
- Status last verified
- Nov 2009
- First submitted
- 22 Sep 2009
- Last updated
- 23 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Facci LM, Nowotny JP, Tormem F, Trevisani VF. Effects of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized clinical trial. Sao Paulo Med J. 2011;129(4):206-16. doi: 10.1590/s1516-31802011000400003.
PubMed 21971895
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Currents (IFC) in Patients With Non Specific Chronic Low Back Pain: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01017913
- Acronym / sponsor ID
- 0143/06
- Conditions
- Chronic Low Back Pain
- Keywords
- rehabilitation, electrotherapy, back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Centro Universitario de Maringa
- Study start
- Mar 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 23 Nov 2009 (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.
The purpose of this study was to compare the effects of the TENS and IFC in patients with non specific chronic low back pain.
Detailed description
Setting Outpatient physiotherapy department in university (Cesumar)
Participants A hundred and fifty patients with non specific chronic low back pain with or without radicular pain.
Interventions The patients were randomly divided into three groups: 1) TENS; 2) IFC; e 3) Control. Ten sessions of electrotherapy for groups 1 and 2, while the patients of the Control group stayed without any treatment in the same period
Main Outcome Measures Intensity of the pain through the Visual Analogue Scale and McGill Pain Questionnaire; specific functional disability by Roland Morris Disability Questionnaire; Analgesic period (hours); and the medication consumption
Statistic Analysis All data were analyzed using Statistica version 7 and SAS version 9.1. Baseline characteristics were compared using the Shapiro-Wilks test for continuous variables and then analysis of variance for measuring independent data. The characteristics of the patients who finished the treatment were compared with those of the lost patients, using one-way ANOVA and the Kruskal-Wallis test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electrotherapy equipment | Active comparator | Other: TENS, Other: Interferential currentsThe TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms with two channels. |
| electrotherapy equipment | Active comparator | Other: TENS, Other: Interferential currentsThe CI was adjusted with 4000 HZ bases frequency, modulation frequency range 20 HZ, ∆F10 HZ, slope 1/1 and quadripolar manner. |
| Control | No intervention | Other: TENSThe patients of the Control group stayed without any treatment in the same period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals who had had low back pain for less than three months
Key exclusion criteria (7 listed)
- Individuals who were receiving treatment for their pain with another method at the same time, except for medicines;
- Pregnant women;
- Patients who had undergone vertebral column surgery (less than three months before the time of this study);
- Individuals with contraindications against electrotherapy, such as skin lesions, abnormal sensitivity, infectious and blood diseases, heart pacemakers or inability to answer questionnaires;
- Patients with fibromyalgia;
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 |
|---|---|---|
| TENSAlso: Transcutaneous electrical nervous stimulationThe TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms (standing in control number seven) with two channels. | Other | Control, Electrotherapy equipment, electrotherapy equipment |
| Interferential currentsAlso: IFC: intereferential currents, electrotherapyThe IFC was adjusted to a base frequency of 4000 Hz, with a modulation frequency range of 20 Hz, ∆F of 10 Hz and slope of 1/1, in quadripolar mode. | Other | Electrotherapy equipment, electrotherapy equipment |
Primary outcome
Pain and Disability
Time frame: Before and after ten sessions (interventions groups) or ten days (control group)
1 secondary outcome
Analgesic period (hours)and medication consumption
Time frame: before and after ten sessions (interventions groups) or ten days (control group)
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 23 Nov 2009.
- Derived from this study: PubMed 21971895Facci LM, Nowotny JP, Tormem F, Trevisani VF. Effects of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized clinical trial. Sao Paulo Med J. 2011;129(4):206-16. doi: 10.1590/s1516-31802011000400003.
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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.
Ligia M Facci principal investigator
Unifesp/ Cesumar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS and Interferential currents in people with Chronic Low Back Pain, run by Federal University of São Paulo at 1 site in Brazil.
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 1 inclusion and 7 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 23 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Pain and Disability (time frame: Before and after ten sessions (interventions groups) or ten days (control group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01017913, which also lists 1 linked publication.
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 23 Nov 2009.