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

NCT04483128 | Completed

• 1 other identifier: CIFSNA2020
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain; Chronic Pain; Autonomic Imbalance

Keywords

electrical stimulation; interferential current; autonomic balance; chronic low back pain

Outcome Measures

Primary Outcomes (14)

• 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.

  Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.

• 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.

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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 Outcomes (4)

• Roland Morris Questionnaire (RMQ-a)

  Evaluation before intervention (basal): 15 minutes before intervention.

• Roland Morris Questionnaire (RMQ-b)

  Evaluation immediately after treatment session.

• Scale for Personal Psychological Apprehension (SPPA)

  Evaluation before intervention (basal): 15 minutes before intervention.

• Dosimetry achieved with electrical stimulation

  Recorded immediately after treatment session.

Study Arms (2)

Sham IFC therapy: Control group

SHAM COMPARATOR

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

IFC therapy: Experimental group

EXPERIMENTAL

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

Interventions

Electrical stimulation: Interferential Current (IFC): Experimental Group DEVICE

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

IFC therapy: Experimental group

Electrical stimulation: Interferential Current (IFC): Control Group DEVICE

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

Sham IFC therapy: Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Manuel Albornoz Cabello

Seville, Spain

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Physiotherapy (PhD)

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 23, 2020
• Study Start: June 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 10, 2020
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)