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NCT Number: NCT06712992

Electromyographic Response to TsDcs in CNSLBP

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic of faculty of physical therapy, Ahram Canadian University, Sixth of October, Giza Governorate, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

conventional exercises

Other
  • Isometric exercises of spine
  • Hollowing in abdominals.
  • Isometric for back extensors.
  • Bridging exercises.
  • Graded active flexion exercises of spine
  • Graded active extension exercises of spine

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 .

Primary outcomes

  1. Changes in NPRS from baseline to four weeks

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

German International University

Other

Registry information

Official study title

Effect of Trans-Spinal Direct Current Stimulation in the Management of Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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