Effect of Trans-Spinal Direct Current Stimulation in the Management of Non-Specific Chronic Low Back Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in NPRS from baseline to four weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Trans-spinal Direct Current Stimulation (Device)
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.
干预措施: Conventional Exercises (Other)
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.
干预措施: Conventional Exercises (Other)
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.
干预措施: SHAM Trans-spinal Direct current stimulation (Drug)
结局指标
主要结局
Changes in NPRS from baseline to four weeks
时间窗: 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
次要结局
- 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)
研究者
Ahmed Medhat Mahfouz Elgamal
Principal invistigator
Cairo University