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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Nociceptive Flexion Reflex (NFR) Threshold and area from baseline to 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient clinic of faculty of physical therapy, Ahram Canadian University | Sixth of October | Giza Governorate | 12611 | Egypt | ||
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Conventional Exercises | Other |
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| 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 . |
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| Baseline and 4 weeks |
| Changes in PROMIS Global Health - 10 Survey from baseline to 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. | Baseline and 4 weeks |
| Outpatient clinical of faculty of physical therapy, Ahram Canadian University |
| Sixth of October |
| Giza Governorate |
| 12611 |
| Egypt |
| D013568 |
| Pathological Conditions, Signs and Symptoms |