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Enrolling by invitation NCT07155837

The Effect of TENS on Early Patient Outcomes After Total Knee Arthroplasty

No phase Interventional Total Knee Replacement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TENS group.
Who it may be relevant to
Registry conditions: Total Knee Replacement. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The Effect of TENS on Early Outcomes in Incisional Wounds After Total Knee Replacement Incisional wounds heal within 3 to 4 weeks, consistent with the normal healing process. However, pain is experienced during the wound healing phase, which can negatively impact patients' recovery. Pharmacological and non-pharmacological methods are used to control pain in the early postoperative period. TENS, in particular, is notable as a non-invasive method, aiming to alleviate pain with low-voltage electrical currents. Studies report that TENS significantly reduces postoperative incisional wound pain. However, the literature demonstrates a limited number of studies on comprehensive pain assessment of incisional wounds using TENS. However, because postoperative incision pain negatively impacts patient outcomes (e.g., pain, mobilization, coughing, sleep), the effectiveness of the analgesia method must be measured. Early pain should be comprehensively assessed to plan effective treatments and improve patient recovery. In this context, the aim of the study was to evaluate the effect of TENS on early pain management in incisional wounds after total knee replacement. The study was designed as a randomized controlled trial. Patients meeting the study's sample criteria will be included. Data collection tools will be a Personal Information Form and the Revised American Pain Society Patient Outcomes Questionnaire (GGAADHSA), which measures the patient's pain assessment in the first 24 hours. TENS will be applied twice (12 hours apart) for 30 minutes each time within the first 24 hours after surgery to the experimental group, while the control group will receive standard treatment. The GGAADHSA questionnaire will be administered once to both groups 24 hours later. The study will evaluate the effect of TENS on early patient outcomes in incisional wounds and contribute to clinical practice in terms of postoperative recovery.

Interventions

  • Device TENS group
    The intervention group received TENS twice a day.

Primary outcome measures

  • Initial 24-hour pain assessment with the Revised American Pain Society Patient Outcomes Questionnaire (GGAADHSA). [Time frame: 12 ay]

Eligibility criteria

Inclusion criteria

\- Patients who are over 18 years of age, A first-time total knee arthroplasty, No psychological distress, Able to communicate effectively, No history of chronic pain, Oriented to person, place, and time, Physician-approved, and have no contraindications to TENS (no pacemaker, no arrhythmia, no epilepsy, etc.), Agree to participate in the study.

Exclusion criteria

\- Patients with metastatic disease, Alcohol, drug, or substance abuse, Have other incisions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Adana Şehir Eğitim ve Araştırma Hastanesi — Adana

Identifiers

NCT: NCT07155837 · ÇukurovaACAR001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗