Electromyographic Response to TsDcs in CNSLBP

German International University

Status: Active, not recruiting

Conditions: Low Back Pain

Treatments: Other: Conventional Exercises; Device: Trans-spinal Direct Current Stimulation; Drug: SHAM Trans-spinal Direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06712992

P.T/REC/2024.10021

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Trans-spinal direct current stimulation group

Experimental group

Description:

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.

Treatment:

Device: Trans-spinal Direct Current Stimulation

Other: Conventional Exercises

Sham Trans-spinal direct current stimulation group

Sham Comparator group

Description:

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.

Treatment:

Drug: SHAM Trans-spinal Direct current stimulation

Other: Conventional Exercises