Pulsed Electromagnetic Field Therapy to a Tailored Exercise Program for Patients Suffering From Chemotherapy-induced Neuropathy Related to Breast Cancer

NCT06947577 | Completed Phase 4

• 1 other identifier: PT.BU.EC.17
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This research studied the usefulness of a targeted intervention designed to manage chemotherapy-induced symptoms, particularly focusing on pain relief, balance deviations and functional improvements. Eighty participants were randomly allocated to either an experimental group, which received a combination of pulsed electromagnetic field (PEMF) therapy and a tailored exercise program (TEP), or a control one that only received the TEP. The study employed several primary measures, including the Visual Analog Scale (VAS) for pain assessment, the Functional Assessment of Cancer Therapy (FACT-Ntx) for evaluating functional status, the Biodex balance system (BBS) for assessing overall sway and stability indices, and nerve conduction velocity (NCV) assessments.

Conditions

Neuropathic

Keywords

Chemotherapy-Induced Symptoms; Pain Management; Functional Outcomes

Outcome Measures

Primary Outcomes (1)

• visual analogue scale

  VAS is a commonly used instrument for evaluating pain intensity, offering a straightforward and effective way for patients to express their pain levels. Typically, the VAS features a straight line, usually measuring 10 centimeters in length, with one end marked "no pain" and the other "worst pain imaginable." Patients are asked to indicate a point on the line that reflects their current pain level, enabling a subjective assessment of pain intensity. The distance measured in millimeters from the "no pain" end to the patient's chosen mark is then converted into a numerical score that ranges from 0 to 10.

  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

Secondary Outcomes (3)

• NCV

  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

• The Functional Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionnaire

  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.

• BBS

  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

Study Arms (2)

experimental group

EXPERIMENTAL

an experimental group, which received a combination of pulsed electromagnetic field (PEMF) therapy and a tailored exercise program (TEP)

Other: pulsed electromagnetic field (PEMF) therapy and a tailored exercise program (TEP); Other: Tailored Exercise Program

control group

ACTIVE COMPARATOR

control group that received a tailored exercise program (TEP)

Other: Tailored Exercise Program

Interventions

pulsed electromagnetic field (PEMF) therapy and a tailored exercise program (TEP) OTHER

pulsed electromagnetic field (PEMF) therapy for addressing chemotherapy-induced peripheral neuritis in the lower limb, patients were first prepared by ensuring they were in a relaxed state, free from distractions, and instructed to remove any metallic items while wearing comfortable clothing. The treatment utilized the ASA Easy Terza series PEMF device from Italy, with each patient positioned comfortably in a supine posture. The device was connected to a 220 V electrical supply, and the solenoid was placed over the lower leg, operating at a frequency of 50 Hz and an intensity of 20 G for a duration of 20 minutes. Patients were situated in a position between sitting and lying, with their lower legs and feet positioned within the solenoid. The setup adhered to the manufacturer's guidelines to ensure effective delivery of the magnetic oscillations, with treatment parameters meticulously adjusted

experimental group

Tailored Exercise Program OTHER

This TEP has been meticulously designed to address the rehabilitation needs of patients dealing with lower limb issues. The program encompasses a comprehensive approach, integrating various types of exercises aimed at enhancing strength, functional mobility, balance, coordination, flexibility, and pain management. The sequence of exercises begins with strengthening exercises targeting key muscle groups such as the gastrocnemius and tibialis anterior, followed by functional training activities that simulate daily movements. This is complemented by balance and coordination drills, coordination drills that challenge stability, and flexibility and stretching exercises to improve range of motion. Additionally, pain management techniques and therapeutic modalities like hot packs are incorporated to alleviate discomfort and enhance relaxation. Finally, the program concludes with low-impact aerobics, such as walking programs, to promote cardiovascular fitness. Prior to commencing the exercise

control group; experimental group

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .
• It was essential for participants to be willing to adhere to the treatment protocol.

You may not qualify if:

• 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.
• 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 - individuals who were unlikely to comply with the treatment protocol or follow-up assessments

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy, Cairo University

Cairo, P.O.Box 11432, Egypt

Location

Related Publications (1)

• Elfahl AM, Abd El Baky AM, Yousef MT, Elgohary HM. High Versus Low Frequency Transcutaneous Electric Nerve Stimulation On Chronic Venous Lower Limb Ulceration Randomized Controlled Trial. Int J Low Extrem Wounds. 2025 Jun;24(2):376-382. doi: 10.1177/15347346221093860. Epub 2022 Apr 14.

  PMID: 35422171 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: assessors were blinded to group assignments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized controlled comparative double-blind trial

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 27, 2025
• Study Start: May 1, 2024
• Primary Completion: May 8, 2024
• Study Completion: December 30, 2024
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)