Electrical Stimulation With Interferential Current in the Non-especific Chronic Low Back Pain: Effects on the Autonomic Nervous System.

June 30, 2021 updated by: Dr. Manuel Albornoz Cabello, University of Seville

The aim of this study it's to analyze the relationship between autonomic nervous system balance (ANSb) and chronic pain conditions, especially in this case, non-especific chronic low back pain (CLBP).

Most of physiotherapy approaches focus only in biomechanical aspects, leaving aside what kind of factors could perpetuate CLBP. Since 1985, ANSb was studied due to its potential contribution to chronic pain.

Electrical stimulation, through interferential currents (IFC), it's a safe and well-known therapy used in CLBP with good outcomes regarding pain relief.

The main objective of this study it's to quantify the association between CLBP and ANSb alterations. In second place, the research team aims to record the influence of IFC over pain and ANSb in those subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In the first place, a meeting will be organized with the patients to resolve any doubt about the study and its process. The investigators will make sure every instruction is understandable, giving enough time to read and ask pertinent questions.

Secondly, patients will be provided of an informed consent specific for the present study, according to the legal forms. Participants must agree with all the information and sign the document.

At this point, patients will be interviewed individually by a researcher to collect all the data regarding to the Clinical History in Physiotherapy.

In the next step, patients will be randomized into two different groups by choosing one opaque envelope, containing a number for the allocation. A researcher will make the final allocation depending on the number. Patients were unaware of the group allocation for masking.

This study has to possible groups with a common indication for both:

  1. Experimental group: Patients allocated in this group will receive one single session of interferential current (IFC). Current used a carrier frequency of 4.000 Hz, 65Hz of amplitude modulated frequency (AMF) with sweep frecuency of 95Hz in a 1:1 swing pattern (quadripolar technique). Intensity was adjusted according to patient's tolerance without visible muscle twitches. The session will last 25 min.
  2. Control group: This group will receive the same intervention than experimental one but with no intensity, for 25 minutes. Patients will keep his general practitioner's indications about pharmacology.
  3. Common indication: Both groups will get instructions to perform a set of home-based exercises for core strengthening after variable collecting.

Before and after the session, all the variable measurements will be collected in the same environmental conditions by the same researcher. Basal measurement (before intervention) will be recorded 15 minutes before session for 10 minutes. The second measurement will be taken while the patient recieves the intervention for 20 minutes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain
        • Manuel Albornoz Cabello

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Subjects diagnosed with cronic low back pain with at least 3 months of evolution.
  • Subjects with a minimal pain of 3/10 according to NPRS
  • Subjects with informed consent read and signed.
  • Subjects not undergoing any other physical therapy intervention.

Exclusion Criteria:

  • Any uncontrolled neurological or cardiac disorder.
  • Personal Psychological Apprehension Scale (PPAS) score higher than 37.5.
  • Contraindication for electrical stimulation.
  • Any regular use of medications known to affect the function of the autonomic nervous system (ANS) or pain perception, including antidepressant, benzodiazepines, anti-inflammatory drugs and beta-blockers, 2 weeks before participating in this study.
  • Ineligibility to participate determined by the researches.
  • Neurological, musculoskeletal or sensory affectations.
  • Evidence of infectious process, fever or hypotension.
  • Metallic implants in low back area or treated area
  • No surgical interventions in low back area
  • Not being under pharmacological treatment with influence in Autonomic Nervous System like antidepressants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham IFC therapy: Control group

This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC).

IFC parameters:

  1. Carrier frequency of 4000 Hz
  2. Amplitude modulated frequency of 65 Hz (AMF)
  3. Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
  4. NO intensity (0 mA)
  5. Session duration: 25 minutes
Device: Electrical stimulation: Interferential Current (IFC): Control Group

Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters:

  1. Carrier frequency of 4000 Hz
  2. Amplitude modulated frequency of 65 Hz (AMF)
  3. Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
  4. NO intensity (0 mA)
  5. Session duration: 25 minutes
Experimental: IFC therapy: Experimental group

This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC).

IFC parameters:

  1. Carrier frequency of 4000 Hz
  2. Amplitude modulated frequency of 65 Hz (AMF)
  3. Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
  4. Intensity will depend on subjet's tolerance but without generating visible muscle twitches.
  5. Session duration: 25 minutes
Device: Electrical stimulation: Interferential Current (IFC): Experimental Group

Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters:

  1. Carrier frequency of 4000 Hz
  2. Amplitude modulated frequency of 65 Hz (AMF)
  3. Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
  4. Intensity will depend on subjet's tolerance but without generate visible muscle twitches.
  5. Session duration: 25 minutes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart Rate variability (HRV-a)
Time Frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Heart Rate variability (HRV) is measured by calculating mean HR, maximum HR and minimum HR. First Beat Bodyguard2 device will be used to collect HRV.
Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Heart Rate variability (HRV-b)
Time Frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
Heart Rate variability (HRV) is measured by calculating mean HR, maximum HR and minimum HR. First Beat Bodyguard2 device will be used to collect HRV.
Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
Root-mean-square differences of successive heartbeat intervals (RMSSD-a)
Time Frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.
Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Root-mean-square differences of successive heartbeat intervals (RMSSD-b)
Time Frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.
Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
Standard Deviation 1 (SD1-a)
Time Frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Standard Deviation 1 (SD1-b)
Time Frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
Standard Deviation 2 (SD2-a)
Time Frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Standard Deviation 2 (SD2-b)
Time Frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
Stress Index (SS-a)
Time Frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.
Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Stress Index (SS-b)
Time Frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.
Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
Sympathetic / Parasympathetic Ratio (S/PS Ratio-a)
Time Frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.
Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Sympathetic / Parasympathetic Ratio (S/PS Ratio-b)
Time Frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.
Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
Numeric Pain Rating Scale (NPRS-a)
Time Frame: Evaluation before intervention (basal): 15 minutes before intervention.
NPRS it's an scale used to measure with ease, patient's perceived pain with a scoring of 0 (no pain) and 10 (maximum pain).
Evaluation before intervention (basal): 15 minutes before intervention.
Numeric Pain Rating Scale (NPRS-b)
Time Frame: Evaluation immediately after treatment session.
NPRS it's an scale used to measure with ease, patient's perceived pain with a scoring of 0 (no pain) and 10 (maximum pain).
Evaluation immediately after treatment session.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Roland Morris Questionnaire (RMQ-a)
Time Frame: Evaluation before intervention (basal): 15 minutes before intervention.
RMQ it's a questionnaire used to measure an individual level of disability related to low back pain, with a scoring of 0 (no disability at all) and 24 (maximum disability).
Evaluation before intervention (basal): 15 minutes before intervention.
Roland Morris Questionnaire (RMQ-b)
Time Frame: Evaluation immediately after treatment session.
RMQ it's a questionnaire used to measure an individual level of disability related to low back pain, with a scoring of 0 (no disability at all) and 24 (maximum disability).
Evaluation immediately after treatment session.
Scale for Personal Psychological Apprehension (SPPA)
Time Frame: Evaluation before intervention (basal): 15 minutes before intervention.
SPPA it's a questionnaire made to measure subject's susceptibility to receive electrical stimulation. A scoring of >45 points indicates that subject shouldnt be treated with electrical therapy.
Evaluation before intervention (basal): 15 minutes before intervention.
Dosimetry achieved with electrical stimulation
Time Frame: Recorded immediately after treatment session.
Maximal dosimetry reached during the session will be recorded in mA.
Recorded immediately after treatment session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Seville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIFSNA2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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