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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483128
• Other study ID #: CIFSNA2020
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 10, 2020

Study information

• Verified date: June 2021
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 10, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Imbalance
• Back Pain
• Chronic Low-back Pain
• Chronic Pain
• Low Back Pain

Intervention

Device:
• Electrical stimulation: Interferential Current (IFC): Experimental Group
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
• Electrical stimulation: Interferential Current (IFC): Control Group
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

Locations

Country	Name	City	State
Spain	Manuel Albornoz Cabello	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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).	Evaluation before intervention (basal): 15 minutes before intervention.
Secondary	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).	Evaluation immediately after treatment session.
Secondary	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.	Evaluation before intervention (basal): 15 minutes before intervention.
Secondary	Dosimetry achieved with electrical stimulation	Maximal dosimetry reached during the session will be recorded in mA.	Recorded immediately after treatment session.