Chronic Pain Clinical Trial
Official title:
Effects of Transcranial Direct Current Stimulation (tDCS) on Pain Associated With Diabetic Neuropathy
The purpose of this study is to investigate the effects of anodal transcranial direct current stimulation (tDCS) on pain intensity associated with diabetic neuropathy. The investigators will conduct real tDCS or sham, over the left dorsolateral prefrontal cortex (DLPFC) during 6 separated days. They will evaluate pain intensity, sleep quality, quality of life and anxiety and depression symptoms via clinical validated scales. The research question is whether tDCS can lessen neuropathic pain and improve sleep, psychological status and quality of life in patients with diabetic neuropathy. It is hypothesized, that less neuropathic pain and improved sleep, psychological status and quality of life after the tDCS sessions.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | September 1, 2022 |
Est. primary completion date | June 6, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patient diagnosed with painful diabetic peripheral neuropathy (PDPN) components with DN4 score = 4/10, and chronic pain with an intensity of at least VAS> 4/10. - Onset of neuropathic PDPN pain for at least 6 months. - Pain intensity as measured by VAS> 4/10 in the week preceding inclusion in the study. - drug-resistant patients who have no pain reduction of 50% or an improvement of at least 2 points in the Patient Global Impression of Change, having used all the classes of drugs indicated as a first, second or third line. - Absence of glycemic de-compensation with HbA1c values <9% in the previous 6 months. - Stability of glycemic control with changes in HbA1c in the last 6 months of less than 2%. Exclusion Criteria - Neurological comorbidities. - Presence of contraindications to the use of electrotherapy (pacemaker, epilepsy, etc ...). - Pregnancy. - Previous neurosurgical interventions. - psychiatric conditions. - Cognitive impairments ( Mini-Mental Status exam (MMSE) <24). - Presence of red flags for pain: tumors, spine fractures, non-neuropathic pain difficult to distinguish from that of the PDPN, neuropathic pain from a cause other than the PDPN. - Severe comorbidities such as advanced renal failure, heart failure, respiratory failure. |
Country | Name | City | State |
---|---|---|---|
Italy | Prof. Silvia Natoli | Roma | Lazio |
Lead Sponsor | Collaborator |
---|---|
University of Rome Tor Vergata |
Italy,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Pain severity | Changes in Pain severity will be measured by Brief Pain Inventory (BPI) to determine the effect of anodal Transcranial direct current stimulation (tDCS) in reducing pain of subjects with pain associated with diabetic neuropathy. | Measured at baseline and immediately after the intervention | |
Secondary | Changes in Depression severity | Changes in depression severity will be measured by Hamilton Depression scale (HAM-D) to determine the effect of anodal Transcranial direct current stimulation (tDCS) in reducing depression severity of subjects with pain associated with diabetic neuropathy. | Measured at baseline and immediately after the intervention | |
Secondary | Changes in Anxiety severity | Changes in Anxiety severity will be measured by Hamilton Anxiety scale (HAM-A) to determine the effect of anodal Transcranial direct current stimulation (tDCS) in reducing anxiety severity of subjects with pain associated with diabetic neuropathy. | Measured at baseline and immediately after the intervention | |
Secondary | Changes in sleep quality | Changes in Sleep quality will be measured by Pittsburgh sleep quality index (PSQI) to determine the effect of anodal Transcranial direct current stimulation (tDCS) in improving sleep quality of subjects with pain associated with diabetic neuropathy. | Measured at baseline and immediately after the intervention | |
Secondary | Changes in Quality of Life | Changes in quality of life will be measured by SF-36 to determine the effect of anodal Transcranial direct current stimulation (tDCS) in improving quality of life of subjects with pain associated with diabetic neuropathy. | Measured at baseline and immediately after the intervention | |
Secondary | Changes in Pain related to disability | The investigators will use the Pain Disability Index (PDI) to assess changes in pain related to disability. | Measured at baseline and immediately after the intervention | |
Secondary | Changes in Pain Catastrophizing | The investigators will use the Pain Catastrophizing Scale (PCS) to assess changes in pain Catastrophizing. | Measured at baseline and immediately after the intervention | |
Secondary | Changes in Neuropathic Pain Symptom | Changes in neuropathic pain symptoms will be measured by Neuropathic Pain Symptom Inventory (NPSI) to determine the effect of anodal Transcranial direct current stimulation (tDCS) in improving and/or reducing neuropathic pain symptom of subjects with pain associated with diabetic neuropathy. | Measured at baseline and immediately after the intervention |
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