Electromyographic Response to TsDcs in CNSLBP

NCT06712992 | Active Not Recruiting

• 1 other identifier: P.T/REC/2024.10021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Changes in NPRS from baseline to four 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

  Baseline and 4 weeks

Secondary Outcomes (2)

• Changes in Nociceptive Flexion Reflex (NFR) Threshold and area from baseline to 4 weeks

  Baseline and 4 weeks

• Changes in PROMIS Global Health - 10 Survey from baseline to 4 weeks

  Baseline and 4 weeks

Study Arms (2)

Trans-spinal direct current stimulation group

EXPERIMENTAL

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.

Device: Trans-spinal Direct Current Stimulation; Other: Conventional Exercises

Sham Trans-spinal direct current stimulation group

SHAM COMPARATOR

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.

Other: Conventional Exercises; Drug: SHAM Trans-spinal Direct current stimulation

Interventions

Trans-spinal Direct Current Stimulation 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.

Trans-spinal direct current stimulation group

Conventional Exercises 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; Trans-spinal direct current stimulation group

SHAM Trans-spinal Direct current stimulation 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 .

Sham Trans-spinal direct current stimulation group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• German International University: lead

Study Sites (2)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Sixth of October, Giza Governorate, 12611, Egypt

Location

Outpatient clinical of faculty of physical therapy, Ahram Canadian University

Sixth of October, Giza Governorate, 12611, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal invistigator

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 3, 2024
• Study Start: May 16, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 10, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)