NCT01017913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
Last Updated

November 23, 2009

Status Verified

November 1, 2009

Enrollment Period

9 months

First QC Date

September 22, 2009

Last Update Submit

November 20, 2009

Conditions

Chronic Low Back Pain

Keywords

rehabilitationelectrotherapyback pain

Outcome Measures

Primary Outcomes (1)

  • Pain and Disability

    Before and after ten sessions (interventions groups) or ten days (control group)

Secondary Outcomes (1)

  • Analgesic period (hours)and medication consumption

    before and after ten sessions (interventions groups) or ten days (control group)

Study Arms (3)

Electrotherapy equipment

ACTIVE COMPARATOR

The TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms with two channels.

Other: TENSOther: 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.

Other: TENSOther: Interferential currents

Control

NO INTERVENTION

The patients of the Control group stayed without any treatment in the same period

Other: TENS

Interventions

TENSOTHER

The TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms (standing in control number seven) with two channels.

Also known as: Transcutaneous electrical nervous stimulation
ControlElectrotherapy equipmentelectrotherapy equipment
Interferential currentsOTHER

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.

Also known as: IFC: intereferential currents, electrotherapy
Electrotherapy equipmentelectrotherapy equipment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who had had low back pain for less than three months

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cesumar

Maringá, Paraná, 87050390, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 21971895DERIVED

MeSH Terms

Conditions

Back Pain

Interventions

Transcutaneous Electric Nerve StimulationElectric Stimulation Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Ligia M Facci

    Unifesp/ Cesumar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2009

First Posted

November 23, 2009

Study Start

March 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2007

Last Updated

November 23, 2009

Record last verified: 2009-11

Locations

BR(1)