Data from the Clinical Trial Testing the Efficiency of the Magicramp Cushion
Version 7.0
Neto, Sodré GB, 2024, “Data from the Clinical Trial Testing the Efficiency of the Magicramp Cushion”, https://doi.org/10.7910/DVN/QUS94U, Harvard Dataverse, V7Cite Dataset
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| Description | Data Availability Statement of Magigramp Trial Clinical (2023) |
|---|---|
| Subject | Medicine, Health and Life Sciences |
| Keyword | cramps, magicramp |
| Related Publication | https://osf.io/preprints/osf/923zm preprint DOI https://doi.org/10.31219/osf.io/923zm |
| Notes | Excel spreadsheet of patients tested with the Magicramp cramp reducer pad. |
| License/Data Use Agreement |  CC0 1.0 |
| 1 to 6 of 6 Files | Edit Files Download | |
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| SKM_C654e22111614360.pdfAdobe PDF – 3.3 MBPublished May 6, 20240 DownloadsMD5: 8b6…1e4 | Preview “SKM_C654e22111614360.pdf”Access FileFile Options | |
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| SKM_C654e22111614363.pdfAdobe PDF – 1.2 MBPublished May 6, 20240 DownloadsMD5: a54…2aa | Preview “SKM_C654e22111614363.pdf”Access FileFile Options | |
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| trial clinical complete .docxEvaluation of the Efficiency of the Magicramp/MS Word – 166.0 KBPublished May 6, 20240 DownloadsMD5: a87…1a2 Evaluation of the Efficiency of the Magicramp® Device for Reducing Cramps Resulting from Oncological Treatments: “Double-blind, Randomized Clinical Trial” | Access FileFile Options | |
| Trial Clinical Magicramp complete.docEvaluation of the Efficiency of the Magicramp Device for Reducing Cramps Resulting from Oncological Treatments Double-blind Randomized Clinical Trial/MS Word – 545.0 KBPublished May 10, 20240 DownloadsMD5: a0b…bfd 3. Results The study involved 40 participants using the Magicramp® MECRC cushion device, where 11 (27.5%) discontinued the research process, divided into four categories: 1) Loss of communication; 2) change in treatment; 3) treatment interruption; and 4) death. In addition to communication loss, for patients who dropped out due to a change in treatment, it was observed that changing the chemotherapy method reduced cramps, making the use of MECRC unnecessary. Of the patients who discontinued chemotherapy treatment, they were automatically no longer available to continue using the product, mainly due to withdrawal, claiming they no longer needed the product since they no longer suffered from cramps. There was a treatment discontinuation caused by the death of a 55-year-old female patient, with non-small cell lung cancer who had been treated with weekly monochemotherapy with CBP+PTX (Carboplatin AUC 2 + Paclitaxel), Cimetidine 300mg/2ml Injectable, Dexamethasone 10mg/2.5ml IV, Docetaxel: 75 mg/m² Ondansetron 8mg/4ml IV, Gemcitabine 1 Gr Inj.). Of the remaining twenty-nine (29) participants, 13 were randomized to the treatment group (TG), and 16 were in the control group (CG); 11 individuals out of 13 who received the true cushion in the TG showed a true positive result (84%), demonstrating the product’s efficacy in reducing cramps, while two (2) out of 13, or 16%, demonstrated the product’s inefficacy. Fourteen (14) individuals in the CG, out of 16 who received placebo, had false-negative results, indicating the absence of the placebo effect in 87.5% of cases. Two (2) participants in the CG reported improvements, even though they received the placebo, resulting in a false-positive rate (12.5%), indicating, in these cases, the prevalence of partially hidden positive effects on the disease/symptom under research. The Predictive Value (PV) is the ability of a test or predictive model to correctly identify true positives and true negatives regarding a certain event or condition. The analysis of the Predictive Value of tests in patients who used MECRC revealed a PPV of 84.6% and an NPV of 12.5%. This indicates that 84.6% experienced a real reduction in cramps when using the product, while 12.5% did not observe this reduction when using MECRC. If we consider each modality, in those who used the active ingredient device, 84% obtained a positive result, and in those who used placebo, only 12.5% obtained a positive result, that is, 87.5% obtained the expected negative result. We did not obtain clear results regarding pain/medication distinction, attributed to the Hospital Araújo Jorge of ACCG in Goiás, Brazil, being rich in medicinal innovations, with numerous clinical trials employing new drugs. Additionally, patient records exhibited a wide variety of new oncological medications. Thus, for our small sample size, establishing causal relationships was unfeasible. Moreover, each participant reported various types of pain from the extensive McGill questionnaire, making it challenging to correlate specific types of pain with their respective medications among the 29 remaining patients with diverse interventions. Figure 1. Absolute General Values of Clinical Trials 4. Conclusions and Importance The efficiency of the MECRC product in the double-blind, randomized clinical trial was assessed based on the analysis of the Predictive Value (PV). The Positive Predictive Value (PPV) of 84.6% indicates that the majority of patients who used the product experienced a real reduction in cramps, confirming its effectiveness. However, the Negative Predictive Value (NPV) of 12.5% reveals the presence of false negatives and 16% of true negatives, indicating that the product may not be effective for all patients. | Access FileFile Options |