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| Name | Class |
|---|---|
| Hoag Memorial Hospital Presbyterian | OTHER |
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The goal of this clinical trial is to examine a low-intensity, low-risk cranial PEMF device and its effectiveness with helping cancer patients manage neuropathy symptoms from chemotherapy. Eligible patients are individuals who have been diagnosed with chemotherapy-induced peripheral neuropathy or are experiencing pain due to chemotherapy and are eighteen to sixty. The main questions the study aims to answer are:
To examine whether the application of low intensity, low frequency PEMF (by the System for Heterogeneous Integrated magnetic Field Transmission (SHIFT)) results in a significant decrease in neuropathic pain intensity.
To examine if SHIFT results in a decrease of pain related interference and associated symptoms of CIPN.
Researchers will compare an active, treatment arm to a placebo, SHAM arm. Participants will be required to use the device once daily, fill out daily, weekly, and monthly surveys. They will have to do one blood draw at the beginning of the study and one at the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Device | Experimental |
| |
| Sham Device | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHIFT | Device | SHIFT is a low intensity PEMF cranial device. It has been designated as a Non-Significant Risk device by the FDA. |
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| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Neuropathic Pain Intensity | Measured through scores in the Neuropathy Pain Scale. The Neuropathy Pain Scale uses a range a 0 to 10, with 0 being no pain/sensation and 10 being the most intense pain/sensation imaginable. | 12 weeks |
| Decrease in Numeric Pain Rating. | Measured through Numeric Pain Rating surveys. The numeric pain rating scale uses a range of 0 to 10, with 0 being no pain and 10 being the worst pain possible. | 12 weeks |
| Improvement in Neuropathic Pain Symptoms | Measured in weekly scores in the Neuropathic Pain Symptom Inventory. The inventory uses a scale of 1 to 10, with 1 being the no symptom and 10 being the worst symptom imaginable. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of pain-related interference | Examine if SHIFT results in a decrease of pain related interferences on a weekly basis. The PEG scale assesses how much pain interferes with weekly abilities on a scale of 0 to 10, with 0 being no interference/pain and ten being complete interference/worst pain imaginable. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Spine Institute | Newport Beach | California | 92663 | United States |
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| Decrease of pain-related stress |
Examine if SHIFT results in a decrease of perceived stress related to pain on a weekly basis, using the perceived stress scale. The PSS examines how well patients have been able to sleep on a scale of 0 to 4 (0 being never and 4 being very often). |
| 12 weeks |
| Decrease of pain-related anxiety | Examine if SHIFT results in a decrease of anxiety related to pain as measured by the GAD-7. The GAD 7 uses a scale of 0 (not at all) to 3 (nearly every day) to measure how often a patient feels anxiety. | 12 weeks |
| Decrease of pain-related inflammatory markers | Examine if SHIFT results in a decrease of inflammatory markers in the blood, specifically a decrease in the presence of IL-6. | 12 weeks |