Use of Transcutaneous Electrical Nerve Stimulation (TENS) in the Treatment of Pain Syndromes in Patients With Lower Limb Ischemia

This study evaluates whether transcutaneous electrical nerve stimulation (TENS), a non-pharmacological and non-invasive method of pain relief, can reduce pain in patients with lower limb ischemia. Peripheral artery disease may lead to severe chronic pain that significantly reduces quality of life and often requires multiple analgesic medications. Participants hospitalized at the Central Clinical Hospital of the Medical University of Warsaw with ischemic lower limb pain will be randomly assigned to receive either active TENS therapy or a sham (placebo) stimulation. During the procedure, electrodes will be placed on the skin near the painful area without breaking the skin. The stimulation session will last 30 minutes. Pain intensity, quality of life, and neuropathic pain features will be assessed s before the intervention, immediately after, and during follow-up at 72 hours and 2 weeks. Standard pharmacological pain treatment will not be modified. The study aims to determine whether TENS can safely reduce pain and improve quality of life, potentially limiting the need for additional analgesic medications.

Inclusion Criteria: * Hospitalization at UCK CSK WUM * Provision of written informed consent * Age ≥18 years * Lower limb pain NRS ≥4 * Lower limb ischemia stage ≥IIb according to the Fontaine classification * Consent to telephone follow-up after therapy Exclusion Criteria: * Lack of informed consent * Hemodynamic instability * Implanted cardiac electrotherapy device or other implanted electronic devices * Inflammation at the electrode application site * Traumatic lower limb amputation * Malignancy at the electrode application site * Previous TENS therapy * Pregnancy * Regional anesthesia, spinal anesthesia, or general anesthesia within the last 24 hours * Impaired consciousness * Limited communication with the patient