The Effectiveness of Adding Pulsed Electromagnetic Field Therapy to a Tailored Exercise Program for Patients Suffering From Chemotherapy-induced Neuropathy Related to Breast Cancer: a Controlled, Double-blind Clinical Trial.

Material and Methods Design A randomized controlled comparative double-blind trial was conducted to assess the effectiveness of various interventions for female participants experiencing lower limb CHIN associated with breast cancer. In this study, both participants and assessors were blinded to group assignments to eliminate bias. A total of eighty female participants were screened and randomly assigned to two groups: the study group, which received a combination of PEMF therapy and TEP, and the control group, which received only TEP. Both groups followed their respective treatment protocols three times a week for six weeks. Assessments measuring postural stability, pain intensity, functional status, and NCV were conducted at three intervals: prior to the interventions, after the six-week treatment period, and again eight weeks post-treatment as a follow- up to evaluate the long-term effects of the interventions.

Participants For the analysis, participants were recruited from the registry files of patients diagnosed with lower limb CHIN associated with breast cancer at the outpatient clinic of the Department of Neurology at Kasr Elaini Hospital, Cairo University. They were examined and diagnosed by a qualified medical practitioner or neurologist. The study required participants to be adults, typically aged 40 or older, and to present with moderate to severe neuropathic symptoms, including pain, numbness, or tingling in the lower limbs (16). It was essential for participants to be willing to adhere to the treatment protocol. Additionally, informed consent was required, ensuring that participants understood the nature of the therapy, along with its potential risks and benefits. Certain conditions excluded individuals from participating in PEMF therapy, including those with implanted medical devices like pacemakers or defibrillators, as well as pregnant individuals. Participants with active infections, open wounds, or severe skin conditions in the treatment area were also disqualified. Individuals with significant cardiovascular issues or other serious health conditions were deemed unsuitable for PEMF therapy. Furthermore, patients who had recently undergone surgery in the targeted area were excluded. Lastly, individuals who were unlikely to comply with the treatment protocol or follow-up assessments were also excluded from the study. All participants ceased the use of any medications intended for the treatment of neuropathy during the treatment protocol.

Sample size A power analysis was conducted to establish the required sample size for the study. This analysis utilized VAS data based on a pilot study, which reported a mean of 7 and a standard deviation of 1.5. With a two-sided significance level set at 0.05 and a desired power of 80%, the effect size was determined to be 1. The calculations indicated that a total of 72 patients would be necessary for the study. To account for a potential dropout rate of 10%, the enrollment was adjusted to 40 patients in each group, leading to a total of 80 participants. All processes involving human subjects complied with the ethical guidelines established by the relevant institutional and national research committees, following the principles outlined in the 1964 Declaration of Helsinki and its later revisions. The Research Ethics Committee of the Faculty of Physical Therapy at Benha University oversaw these standards and approved the study (---------------------------). Participants were thoroughly informed about the study design, both verbally and in writing, and all individuals provided signed informed consent to participate.

Measures To accumulate desired data for the analysis, for all subjects, the BBS was used for the measurement of postural stability, pain intensity was measured by VAS, FACT-Ntx) for evaluating functional status. furthermore, NCV was performed to objectively assess nerve function. Each assessment method was conducted at the beginning of the treatment to establish a baseline, again after six weeks of intervention, and finally eight weeks later for follow-up after the completion of the interventions.

BBS BBS- SD (950-440 with version 4.X software was utilized as an objective assessment tool to evaluate postural stability in this study. This device, equipped with version 4.X software, is specifically designed to measure and train postural stability on both stable and unstable surfaces. The system features a mobile platform that can tilt up to 20 degrees in all directions and offers 12 levels of difficulty. The Stability Index of the BBS is a key metric used in various studies to assess postural stability, focusing on a patient's ability to maintain their center of balance. The system calculated several parameters, including the overall sway index (OSWI), and the overall stability index (OSI), which reflect the degree of tilt across the anterior-posterior (AP) and medial-lateral (ML) dimensions. A lower score on this assessment indicated better stability, as it represents fewer deviations from the center. To conduct the Postural Stability Test, several steps were followed to ensure accurate measurements. Initially, the support handles and display settings were adjusted for patient comfort. The patient's name and height were entered into the system. The platform's stability was set to static for the initial trial and adjusted to level 4 for the final assessment. The patient was positioned to align their center of gravity with the system's axis, and their foot placements were recorded. After initiating the test, data collection commenced with a three-second countdown, followed by multiple trials to assess stability. Upon completion, results were displayed, allowing for further analysis and documentation of the patient's postural stability performance. BBS was conducted at three intervals: prior to the interventions, after the six-week treatment period, and again eight weeks post-treatment as a follow- up to evaluate the long-term effects of the interventions (17).