Effect of Trans-Spinal Direct Current Stimulation in the Management of Non-Specific Chronic Low Back Pain: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Trans-spinal Direct Current Stimulation
- Conditions
- Low Back Pain
- Sponsor
- German International University
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Changes in NPRS from baseline to four weeks
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Ahmed Medhat Mahfouz Elgamal
Principal invistigator
Cairo University
Eligibility Criteria
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
- •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.
Arms & Interventions
Trans-spinal direct current stimulation group
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.
Intervention: Trans-spinal Direct Current Stimulation
Trans-spinal direct current stimulation group
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.
Intervention: Conventional Exercises
Sham Trans-spinal direct current stimulation group
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.
Intervention: Conventional Exercises
Sham Trans-spinal direct current stimulation group
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.
Intervention: SHAM Trans-spinal Direct current stimulation
Outcomes
Primary Outcomes
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
- 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)