Use of Transcutaneous Electrical Nerve Stimulation (TENS) in the Treatment of Pain Syndromes in Patients With Lower Limb Ischemia
NCT07925060, Not applicable, Active not recruiting, Medical University of Warsaw
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Use of Transcutaneous Electrical Nerve Stimulation (TENS) in the Treatment of Pain Syndromes in Patients With Lower Limb Ischemia | ClinicalTrials.gov |
| NCT number | NCT07925060 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 150 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Medical University of Warsaw | ClinicalTrials.gov |
| Conditions | Ischemic Pain of the Lower Extremity, Neuropathic Pain | ClinicalTrials.gov |
| Interventions | TENS, Sham TENS | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Numeric Rating Scale (NRS) pain score | Immediately before TENS stimulation, immediately after TENS stimulation, 30 minutes after TENS stimulation, 72 hours after TENS stimulation, and 2 weeks after TENS stimulation. | 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. | ClinicalTrials.gov |
| Secondary | 36-Item Short Form Health Survey (SF-36) - Physical Functioning score | Immediately before TENS stimulation, and 2 weeks after TENS stimulation | 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. | ClinicalTrials.gov |
| Secondary | Douleur Neuropathique en 4 Questions (DN4) score | Immediately before TENS stimulation and 2 weeks after TENS stimulation. | 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. | ClinicalTrials.gov |
| Secondary | Systolic blood pressure | Immediately before TENS stimulation, immediately after TENS stimulation, 30 minutes after TENS stimulation, and 72 hours after TENS stimulation. | Systolic blood pressure measured at each assessment time point, expressed in millimeters of mercury (mmHg) | ClinicalTrials.gov |
| Secondary | Diastolic blood pressure | Immediately before TENS stimulation, immediately after TENS stimulation, 30 minutes after TENS stimulation, and 72 hours after TENS stimulation. | Diastolic blood pressure measured at each assessment time point, expressed in millimeters of mercury (mmHg) | ClinicalTrials.gov |
| Secondary | Heart rate | Immediately before TENS stimulation, immediately after TENS stimulation, 30 minutes after TENS stimulation, and 72 hours after TENS stimulation. | Heart rate measured at each assessment time point, expressed as beats per minute. | ClinicalTrials.gov |
| Secondary | Respiratory rate | Immediately before TENS stimulation, immediately after TENS stimulation, 30 minutes after TENS stimulation, and 72 hours after TENS stimulation. | Respiratory rate measured at each assessment time point, expressed as breaths per minute. | ClinicalTrials.gov |
| Secondary | Number of Analgesic Administrations per Participant | 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 | 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 | ClinicalTrials.gov |
| Secondary | Opioid Consumption in Oral Morphine Milligram Equivalents (MME) | 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 | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)