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

Primary Purpose

Chronic Low-back Pain, Chronic Pain, Autonomic Imbalance

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Electrical stimulation: Interferential Current (IFC): Experimental Group
Electrical stimulation: Interferential Current (IFC): Control Group
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Low-back Pain focused on measuring electrical stimulation, interferential current, autonomic balance, chronic low back pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Manuel Albornoz Cabello

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham IFC therapy: Control group

IFC therapy: Experimental group

Arm Description

This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC). IFC parameters: Carrier frequency of 4000 Hz Amplitude modulated frequency of 65 Hz (AMF) Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique. NO intensity (0 mA) Session duration: 25 minutes

This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC). IFC parameters: Carrier frequency of 4000 Hz Amplitude modulated frequency of 65 Hz (AMF) Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique. Intensity will depend on subjet's tolerance but without generating visible muscle twitches. Session duration: 25 minutes

Outcomes

Primary Outcome Measures

Heart Rate variability (HRV-a)
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.
Heart Rate variability (HRV-b)
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.
Root-mean-square differences of successive heartbeat intervals (RMSSD-a)
RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.
Root-mean-square differences of successive heartbeat intervals (RMSSD-b)
RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.
Standard Deviation 1 (SD1-a)
SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Standard Deviation 1 (SD1-b)
SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Standard Deviation 2 (SD2-a)
SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Standard Deviation 2 (SD2-b)
SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Stress Index (SS-a)
SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.
Stress Index (SS-b)
SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.
Sympathetic / Parasympathetic Ratio (S/PS Ratio-a)
S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.
Sympathetic / Parasympathetic Ratio (S/PS Ratio-b)
S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.
Numeric Pain Rating Scale (NPRS-a)
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).
Numeric Pain Rating Scale (NPRS-b)
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).

Secondary Outcome Measures

Roland Morris Questionnaire (RMQ-a)
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).
Roland Morris Questionnaire (RMQ-b)
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).
Scale for Personal Psychological Apprehension (SPPA)
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.
Dosimetry achieved with electrical stimulation
Maximal dosimetry reached during the session will be recorded in mA.

Full Information

First Posted
July 14, 2020
Last Updated
June 30, 2021
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT04483128
Brief Title
Electrical Stimulation With Interferential Current in the Non-especific Chronic Low Back Pain: Effects on the Autonomic Nervous System.
Official Title
Electrical Stimulation With Interferential Current in the Non-especific Chronic Low Back Pain: Effects on the Autonomic Nervous System.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain, Chronic Pain, Autonomic Imbalance
Keywords
electrical stimulation, interferential current, autonomic balance, chronic low back pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants diagnosed with chronic low back pain will be divided into two different groups with 28 patients each: Experimental group: Participants in this group will receive electrical stimulation with interferential current. They will get also instructions to perform core strengthening exercises at home, after variable collection. Control group: Participants in this group will recieve the same electrical stimulation than in the experimental group but with no intensity. This group will get too instructions to perform core strengthening exercises at home (after variable collection) and follow General Practitioner indications about pharmacology.
Masking
Participant
Masking Description
Randomization process will be masked by opaques envelopes with numbers. Participants choose one random envelope, unaware the number and group relation. Later, a researcher will associate participants, groups and numbers.
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham IFC therapy: Control group
Arm Type
Sham Comparator
Arm Description
This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC). IFC parameters: Carrier frequency of 4000 Hz Amplitude modulated frequency of 65 Hz (AMF) Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique. NO intensity (0 mA) Session duration: 25 minutes
Arm Title
IFC therapy: Experimental group
Arm Type
Experimental
Arm Description
This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC). IFC parameters: Carrier frequency of 4000 Hz Amplitude modulated frequency of 65 Hz (AMF) Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique. Intensity will depend on subjet's tolerance but without generating visible muscle twitches. Session duration: 25 minutes
Intervention Type
Device
Intervention Name(s)
Electrical stimulation: Interferential Current (IFC): Experimental Group
Intervention Description
Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters: Carrier frequency of 4000 Hz Amplitude modulated frequency of 65 Hz (AMF) Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique. Intensity will depend on subjet's tolerance but without generate visible muscle twitches. Session duration: 25 minutes
Intervention Type
Device
Intervention Name(s)
Electrical stimulation: Interferential Current (IFC): Control Group
Intervention Description
Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters: Carrier frequency of 4000 Hz Amplitude modulated frequency of 65 Hz (AMF) Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique. NO intensity (0 mA) Session duration: 25 minutes
Primary Outcome Measure Information:
Title
Heart Rate variability (HRV-a)
Description
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.
Time Frame
Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Title
Heart Rate variability (HRV-b)
Description
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.
Time Frame
Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
Title
Root-mean-square differences of successive heartbeat intervals (RMSSD-a)
Description
RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.
Time Frame
Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Title
Root-mean-square differences of successive heartbeat intervals (RMSSD-b)
Description
RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.
Time Frame
Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
Title
Standard Deviation 1 (SD1-a)
Description
SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Time Frame
Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Title
Standard Deviation 1 (SD1-b)
Description
SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Time Frame
Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
Title
Standard Deviation 2 (SD2-a)
Description
SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Time Frame
Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Title
Standard Deviation 2 (SD2-b)
Description
SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Time Frame
Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
Title
Stress Index (SS-a)
Description
SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.
Time Frame
Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Title
Stress Index (SS-b)
Description
SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.
Time Frame
Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
Title
Sympathetic / Parasympathetic Ratio (S/PS Ratio-a)
Description
S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.
Time Frame
Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Title
Sympathetic / Parasympathetic Ratio (S/PS Ratio-b)
Description
S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.
Time Frame
Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
Title
Numeric Pain Rating Scale (NPRS-a)
Description
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).
Time Frame
Evaluation before intervention (basal): 15 minutes before intervention.
Title
Numeric Pain Rating Scale (NPRS-b)
Description
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).
Time Frame
Evaluation immediately after treatment session.
Secondary Outcome Measure Information:
Title
Roland Morris Questionnaire (RMQ-a)
Description
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).
Time Frame
Evaluation before intervention (basal): 15 minutes before intervention.
Title
Roland Morris Questionnaire (RMQ-b)
Description
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).
Time Frame
Evaluation immediately after treatment session.
Title
Scale for Personal Psychological Apprehension (SPPA)
Description
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.
Time Frame
Evaluation before intervention (basal): 15 minutes before intervention.
Title
Dosimetry achieved with electrical stimulation
Description
Maximal dosimetry reached during the session will be recorded in mA.
Time Frame
Recorded immediately after treatment session.

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Manuel Albornoz Cabello
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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