Transcutaneous Electrical Nerve Stimulation and Interferential Currents in Chronic Low Back Pain
| Tracking Information | |||||
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| First Received Date ICMJE | September 22, 2009 | ||||
| Last Updated Date | November 20, 2009 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pain and Disability [ Time Frame: Before and after ten sessions (interventions groups) or ten days (control group) ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01017913 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Analgesic period (hours)and medication consumption [ Time Frame: before and after ten sessions (interventions groups) or ten days (control group) ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Transcutaneous Electrical Nerve Stimulation and Interferential Currents in Chronic Low Back Pain | ||||
| Official Title ICMJE | Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Currents (IFC) in Patients With Non Specific Chronic Low Back Pain: Randomized Clinical Trial | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Low Back Pain | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 150 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01017913 | ||||
| Other Study ID Numbers ICMJE | 0143/06 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Currents (IFC) in patients with non specific chronic low back pain: randomized clinical trial, Unifesp/ Cesumar | ||||
| Study Sponsor ICMJE | Federal University of São Paulo | ||||
| Collaborators ICMJE | Centro Universitario de Maringa | ||||
| Investigators ICMJE |
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| Information Provided By | Federal University of São Paulo | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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