Electromyographic Response to TsDcs in CNSLBP

Not Applicable

Active, not recruiting

• Conditions: Low Back Pain
• Interventions: Device: Trans-spinal Direct Current Stimulation; Other: Conventional Exercises; Drug: SHAM Trans-spinal Direct current stimulation

• Registration Number: NCT06712992
• Lead Sponsor: German International University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-16
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-30
• Study First Posted: 2024-12-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trans-spinal direct current stimulation group	Trans-spinal Direct Current Stimulation	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.
Trans-spinal direct current stimulation group	Conventional Exercises	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.
Sham Trans-spinal direct current stimulation group	Conventional Exercises	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.
Sham Trans-spinal direct current stimulation group	SHAM Trans-spinal Direct current stimulation	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.

Primary Outcome Measures

Name	Time	Method
Changes in NPRS from baseline to four weeks	Baseline and 4 weeks	An 11-point Numerical Pain Rating Scale (NPRS; 0= no pain, 10= maximum pain) will be used to assess the patients' pre and post treatment levels of back pain. The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion. Scores range from 0-10 points, with higher scores indicating greater pain intensity

Secondary Outcome Measures

Name	Time	Method
Changes in Nociceptive Flexion Reflex (NFR) Threshold and area from baseline to 4 weeks	Baseline and 4 weeks	The NFR threshold will be assessed as an objective measure of spinal nociceptive processing in adults with chronic non-specific low back pain (CNSLBP). The NFR threshold will be defined as the lowest stimulus intensity that elicits an NFR response.The NFR threshold and NFR area will be assessed before and after 4 weeks of trans-spinal direct current stimulation (tsDCS) plus exercise or sham stimulation plus exercise.
Changes in PROMIS Global Health - 10 Survey from baseline to 4 weeks	Baseline and 4 weeks	The Patient-Reported Outcomes Measurement Information System (PROMIS) is a comprehensive instrument designed to assess health-related quality of life across various domains. PROMIS GH-10, specifically, is tailored to measure global physical and mental health. It encompasses a range of items that evaluate general health perceptions, physical function, pain, fatigue, emotional distress, and social health. PROMIS GH-10 has been demonstrated to be reliable and valid for use in the general population and various specific conditions, such as low back pain.

Trial Locations

Locations (2)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University; 🇪🇬 Sixth of October, Giza, Egypt

Outpatient clinical of faculty of physical therapy, Ahram Canadian University; 🇪🇬 sixth of October, Giza, Egypt