Electromyographic Response to TsDcs in CNSLBP

NCT ID: NCT06712992

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-16
• Study Completion Date: 2025-04-10

Brief Summary

The purpose of this randomized, double-blinded, sham-controlled study is to investigate the efficacy of trans-spinal direct current stimulation on pain level, quality of life, and electromyographic nociceptive flexion reflex in patients with non-specific chronic low back pain.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Trans-spinal direct current stimulation group

Patients in this group will receive Conventional Exercises in addition to tsDCS. We will apply a current density of 0.035 mA/cm2 and will deliver a total charge density of 42.8 mC/cm2, below the threshold values reported for tissue damage. For tsDcs, At the onset of tsDCS, the current will be increased for 30 s, and at the offset, it will be decreased for 30 s in a ramp-like manner. Participants will receive three sessions of treatment per week for four weeks, with a total of twelve sessions.

Group Type: EXPERIMENTAL

Trans-spinal Direct Current Stimulation

Intervention Type: DEVICE

Physiomed- IONOSON-Expert, Germany will be used to deliver SHAM direct current, The Physiomed- IONOSON-Expert, Germany is Two-channel electrotherapy including 21 currents, including direct current. The tsDCS electrodes will be rectangular pieces of saline-soaked synthetic sponge (7 × 8 cm, 56 cm2), to minimize chemical reactions at the electrode-skin interface. The anode will be placed over the spinous process of the eighth thoracic vertebra (T8) and the cathode will be placed on the second lumbar vertebra (L2) according to a modeling study which demonstrated that this configuration had a relevant impact on the distribution of the induced electric field (EF) in the lumbosacral spinal cord for the efficacy of tsDCS.

Conventional Exercises

Intervention Type: OTHER

1. Isometric exercises of spine

• Hollowing in abdominals.
• Isometric for back extensors.

2. Bridging exercises.

3. Graded active flexion exercises of spine

4. Graded active extension exercises of spine

Sham Trans-spinal direct current stimulation group

Patients in this group will receive Conventional Exercises in addition to SHAM tsDCS. For a sham tsDCS, the current will be ramped up for 30 seconds turned on for 5 s and then turned off in a ramp shaped fashion, thus inducing skin sensations indistinguishable from anodal tsDCS. This method was shown to achieve a good level of blinding among sessions. Participants will receive three sessions of treatment per week for four weeks, with a total of twelve sessions.

Group Type: SHAM_COMPARATOR

Conventional Exercises

Intervention Type: OTHER

1. Isometric exercises of spine

• Hollowing in abdominals.
• Isometric for back extensors.

2. Bridging exercises.

3. Graded active flexion exercises of spine

4. Graded active extension exercises of spine

SHAM Trans-spinal Direct current stimulation

Intervention Type: DRUG

For a sham tsDCS, the current will be ramped up for 30 seconds turned on for 5 s and then turned off in a ramp shaped fashion, thus inducing skin sensations indistinguishable from anodal tsDCS. This method was shown to achieve a good level of blinding among sessions.

These parameters for sham stimulation were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade usually out in the first 30 s of TsDcs .

Interventions

Trans-spinal Direct Current Stimulation

Physiomed- IONOSON-Expert, Germany will be used to deliver SHAM direct current, The Physiomed- IONOSON-Expert, Germany is Two-channel electrotherapy including 21 currents, including direct current. The tsDCS electrodes will be rectangular pieces of saline-soaked synthetic sponge (7 × 8 cm, 56 cm2), to minimize chemical reactions at the electrode-skin interface. The anode will be placed over the spinous process of the eighth thoracic vertebra (T8) and the cathode will be placed on the second lumbar vertebra (L2) according to a modeling study which demonstrated that this configuration had a relevant impact on the distribution of the induced electric field (EF) in the lumbosacral spinal cord for the efficacy of tsDCS.

Intervention Type: DEVICE

Conventional Exercises

1. Isometric exercises of spine

• Hollowing in abdominals.
• Isometric for back extensors.

2. Bridging exercises.

3. Graded active flexion exercises of spine

4. Graded active extension exercises of spine

Intervention Type: OTHER

SHAM Trans-spinal Direct current stimulation

For a sham tsDCS, the current will be ramped up for 30 seconds turned on for 5 s and then turned off in a ramp shaped fashion, thus inducing skin sensations indistinguishable from anodal tsDCS. This method was shown to achieve a good level of blinding among sessions.

These parameters for sham stimulation were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade usually out in the first 30 s of TsDcs .

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Individuals of both sexes.
• Age 18-60 years old.
• Chronic non-specific low back pain according to the most recent guidelines for the diagnosis and management of NSLPB come from the American College of Physicians and was published in 2017. According to these guidelines, the diagnosis of chronic NSLBP should be made based on the following criteria:
• Chronic low back pain, defined as pain lasting for more than 12 weeks.
• No specific identifiable cause of pain(e.g. infection, malignancy, fracture, inflammatory disorder).
• No radicular symptoms(e.g. pain radiating down the leg).
• No significant neurological deficits or findings on physical examination(e.g. loss of reflexes or muscle strength).

Exclusion Criteria

• Previous fractures and/or surgery in the vertebral spine.
• Neuropathic pain extending along the lower limb due to nerve root compression.
• History of spine trauma or fracture.
• Implanted pacemakers.
• Pregnancy.
• Malignancy.
• Systemic musculoskeletal diseases.
• Epilepsy.
• History of psychiatric disorders.
• Obesity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German International University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Medhat Mahfouz Elgamal

Principal invistigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Sixth of October, Giza Governorate, Egypt

Outpatient clinical of faculty of physical therapy, Ahram Canadian University

Sixth of October, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

P.T/REC/2024.10021

Identifier Type: -

Identifier Source: org_study_id