Chemotherapy-induced peripheral neuropathy
Conditions
Interventions
The study consists of a 1-week baseline phase with standard physical therapy alone, a 1-month intervention phase with dysesthesia-matched TENS combined with standard physical therapy, and a 1-month fo
Sponsors
Nagasaki University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Outpatients with chemotherapy-induced peripheral neuropathy in the hands and/or feet; 2) age under 80 years; 3) at least 3 months after completion of chemotherapy; 4) diagnosis of chemotherapy-induced peripheral neuropathy by a physician; 5) numbness or pain intensity of 3/10 or higher on the Numerical Rating Scale; 6) ability to provide written informed consent; and 7) permission for electrical stimulation therapy from the attending physician.
Exclusion criteria
Exclusion criteria: 1) Cognitive impairment defined as a Mini-Mental State Examination score of 24 or lower; 2) peripheral neuropathy before chemotherapy, such as neuropathy due to diabetes or central nervous system disease; 3) implanted electrical devices such as a pacemaker; 4) refusal by the participant or family to continue participation during the study; and 5) worsening physical condition or other conditions judged to make continuation of assessment or intervention inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the subjective intensity of numbness assessed using the Numerical Rating Scale. Specifically, changes in NRS before and after each dysesthesia-matched TENS session during the intervention phase and daily changes in NRS across the baseline, intervention, and follow-up phases will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include pain intensity assessed using the Brief Pain Inventory intensity scale, pain interference assessed using the Brief Pain Inventory interference scale, pain distribution assessed using pain drawings, severity of chemotherapy-induced peripheral neuropathy assessed using the Patient Neurotoxicity Questionnaire, neuropathic pain symptoms assessed using the Neuropathic Pain Symptom Inventory, quantitative assessment of the fineness and intensity of dysesthesia using electrical stimulation, vibration sense and superficial sensation as quantitative sensory testing, central sensitization-related symptoms assessed using the CSI-9, pain catastrophizing assessed using the PCS-6, anxiety assessed using the GAD-2, depression assessed using the PHQ-2, balance function assessed using the Berg Balance Scale, physical activity assessed using the Global Physical Activity Questionnaire, and adverse events. | — |
Countries
Japan
Contacts
Public ContactYuki Nishi
Nagasaki university Biomedical Sciences (Health Sciences)
Outcome results
None listed