An interventional study of TENS and Sham TENS in Ischemic Pain of the Lower Extremity and Neuropathic Pain, sponsored by Medical University of Warsaw. Active, not recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment
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.
This is a prospective, randomized, patient-blinded clinical trial designed to evaluate the analgesic efficacy of transcutaneous electrical nerve stimulation (TENS) in patients with lower limb ischemic pain.
Adult patients (≥18 years) hospitalized at the Central Clinical Hospital of the Medical University of Warsaw with Fontaine stage ≥IIb ischemia and pain intensity ≥4 on the Numeric Rating Scale (NRS) will be enrolled after providing written informed consent. Participants will be randomized in a 1:1 ratio using a computer-generated algorithm to receive either active TENS or sham stimulation.
In both groups, electrodes will be placed above and below the painful area along the course of the nerve supplying the region. TENS will be used (initial parameters: 100 Hz, pulse duration 150 μs). In the active group, stimulation intensity-electrical current- will be increased until strong but comfortable paresthesia is achieved. In the control group, stimulation parameters will not be further increased. Each session will last 30 minutes. Patients will be blinded to group allocation and device settings. Baseline analgesic therapy will remain unchanged.
Assessments will include:
pain intensity (NRS), neuropathic pain features (DN4), quality of life (SF-36), vital signs (blood pressure, heart rate, respiratory rate).
Measurements will be performed at baseline, immediately after the intervention, 30 minutes after the intervention, and during follow-up at 72 hours and 2 weeks (telephone assessment).
The primary endpoint is the change in NRS pain score after TENS therapy. Secondary endpoints include correlations between stimulation intensity and pain reduction, changes in vital signs, the relationship between DN4 and SF-36 scores and analgesic response, and changes in analgesic consumption..
The study is expected to demonstrate that TENS is a safe and effective non-pharmacological method for reducing ischemic lower limb pain and may contribute to reducing polypharmacy.
1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.
This study's planned enrollment of 150 is above the median of 52 across 831 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single 30-minute session of active TENS. Stimulation intensity will be increased until strong but comfortable paresthesia is achieved. Electrodes will be placed above and below the painful area along the course of the corresponding nerve.
Device: TENS
Participants will receive a single 30-minute session of sham TENS. Electrodes will be placed in the same way as in the active group, but stimulation intensity will not be increased to a therapeutic level.
Device: Sham TENS
Transcutaneous Electrical Nerve Stimulation (TENS) will be administered using surface electrodes placed above and below the painful area of the lower limb along the course of the affected nerve. In the active intervention group, stimulation will be delivered using TENS (with an initial frequency of 100 Hz and pulse duration of 150 microseconds and current intensity of 1mA). Current intensity will be gradually increased until strong but comfortable paresthesia is achieved. Each session will last 30 minutes.
In the control (sham) group, identical electrode placement and initial parameters (100 Hz, 150 microseconds and current intensity of 1mA) will be applied; however, stimulation intensity will not be increased to therapeutic levels. Each session will last 30 minutes.
Numeric Rating Scale (NRS) pain score
Pain intensity assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Time frame: Immediately before TENS stimulation, immediately after TENS stimulation, 30 minutes after TENS stimulation, 72 hours after TENS stimulation, and 2 weeks after TENS stimulation.
36-Item Short Form Health Survey (SF-36) - Physical Functioning score
Quality of life assessed using the 36-Item Short Form Health Survey (SF-36). The Physical Functioning domain is scored from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Immediately before TENS stimulation, and 2 weeks after TENS stimulation
Douleur Neuropathique en 4 Questions (DN4) score
Neuropathic pain assessed using the Douleur Neuropathique en 4 Questions (DN4) questionnaire. The total score ranges from 0 to 10 points, with higher scores indicating a greater likelihood of neuropathic pain. A score of 4 or higher is considered suggestive of neuropathic pain.
Time frame: Immediately before TENS stimulation and 2 weeks after TENS stimulation.
Systolic blood pressure
Systolic blood pressure measured at each assessment time point, expressed in millimeters of mercury (mmHg)
Time frame: Immediately before TENS stimulation, immediately after TENS stimulation, 30 minutes after TENS stimulation, and 72 hours after TENS stimulation.
Diastolic blood pressure
Diastolic blood pressure measured at each assessment time point, expressed in millimeters of mercury (mmHg)
Time frame: Immediately before TENS stimulation, immediately after TENS stimulation, 30 minutes after TENS stimulation, and 72 hours after TENS stimulation.
Heart rate
Heart rate measured at each assessment time point, expressed as beats per minute.
Time frame: Immediately before TENS stimulation, immediately after TENS stimulation, 30 minutes after TENS stimulation, and 72 hours after TENS stimulation.
Respiratory rate
Respiratory rate measured at each assessment time point, expressed as breaths per minute.
Time frame: Immediately before TENS stimulation, immediately after TENS stimulation, 30 minutes after TENS stimulation, and 72 hours after TENS stimulation.
Number of Analgesic Administrations per Participant
Total number of analgesic medication administrations per participant within each assessment window. All analgesic drugs are counted together regardless of drug, drug class, route or dose; each single administration of any analgesic counts as one administration. Data will be collected from medical records (during hospitalization) and from a structured telephone interview (after discharge). The result is reported as a single value: the number of administrations per participant. Unit of Measure: administrations per participant
Time frame: 72 hours before the TENS session (baseline), 0-72 hours after the TENS session, and from 72 hours to 2 weeks after the TENS session
Opioid Consumption in Oral Morphine Milligram Equivalents (MME)
otal opioid dose received per participant within each assessment window. All opioids (e.g., morphine, oxycodone) will be converted to oral morphine milligram equivalents using standard equianalgesic conversion factors and summed to give a single value per participant. Non-opioid analgesics are not included in this measure; they are captured in the count of analgesic administrations (Secondary Outcome 3). Data will be collected from medical records and a structured telephone interview. Unit of Measure: mg of oral morphine equivalents
Time frame: 72 hours before the TENS session (baseline), 0-72 hours after the TENS session, and from 72 hours to 2 weeks after the TENS session
Plan to share: No
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