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

NCT07155837 | Enrolling By Invitation

• 1 other identifier: ÇukurovaACAR001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Replacement

Keywords

TENS

Outcome Measures

Primary Outcomes (1)

• Initial 24-hour pain assessment with the Revised American Pain Society Patient Outcomes Questionnaire (GGAADHSA).

  This questionnaire measures multidimensional patient outcomes such as pain intensity, impact of pain on daily life (mobilization, sleep, coughing, etc.), and satisfaction with analgesia.

  12 ay

Study Arms (1)

Kontrol Grubu

EXPERIMENTAL

Device: TENS group

Interventions

TENS group DEVICE

The intervention group received TENS twice a day.

Kontrol Grubu

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Adana Şehir Eğitim ve Araştırma Hastanesi

Adana, Adana, 01030, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: September 4, 2025
• Study Start: December 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: September 15, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

TU (1)