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

NCT ID: NCT04483128

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-12-10

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:

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.

Conditions

Chronic Low-back Pain; Chronic Pain; Autonomic Imbalance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: SHAM_COMPARATOR

Electrical stimulation: Interferential Current (IFC): Control Group

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Electrical stimulation: Interferential Current (IFC): Experimental Group

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Dr. Manuel Albornoz Cabello

Doctor in Physiotherapy (PhD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Manuel Albornoz Cabello

Seville, , Spain

Countries

Spain

Other Identifiers

CIFSNA2020

Identifier Type: -

Identifier Source: org_study_id