Electromyographic Response to TsDcs in CNSLBP

NCT06712992 · tracked via the Priya Life Science Egypt tracker

Sponsor

German International University

Phase

Not applicable

Started

2024-05-16

Last updated

2025-03-12

Condition(s) studied

Low Back Pain

Investigational drug(s) / intervention(s)

Trans-spinal Direct Current StimulationConventional ExercisesSHAM Trans-spinal Direct current stimulation

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.

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

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 .

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

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

Primary outcome measure(s)

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

Trial sites (2)

Facility	City	Region	Status
Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Sixth of October	Giza Governorate
Outpatient clinical of faculty of physical therapy, Ahram Canadian University	Sixth of October	Giza Governorate

More German International University trials in Egypt

Shock Wave Versus Traditional Physical Therapy for Adult Chronic Knee Osteoarthritis Recruiting

Other trials for the same condition

the Role of MRI in Evaluation of Low Back Pain Recruiting

Effect of Manual Therapy on Low Back Pain in Osteopenic Postmenopausal Women Recruiting

The Effect of Sensory Motor Training on Postural Stability in Post-menopausal Women With Non-specific Low Back Pain Starting soon

Effect of Acupressure Versus Kinesotape on Low Back Pain in Women Who Use Intrauterine Device Starting soon

Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06712992 on ClinicalTrials.gov ↗ ← All trials in Egypt