Does Edema Affect the Adjustment of TENS Amplitude

Does Edema After Knee Arthroplasty Affect the Adjustment of TENS Amplitude

The goal of this pre-post clinical trial is to compare the amplitude settings of three different frequency TENS modes (Conventional TENS, LF TENS, HF TENS) in patients who had undergone total knee arthroplasty, both with the preoperative state and with the contralateral knee. The main question it aims to answer is: Can the electrical resistance of edematous tissue be affected and change the TENS amplitude setting? Participants will be evaluated before and after surgery. For each TENS modulation the amplitude at which tingling is felt, the current is clearly felt, and is maximum tolerated and/or muscle contraction occurred, will be documented. TENS amplitudes for all three TENS modes will be compared, both with the preoperative state and with the contralateral knee.

Study Overview

• Status: Recruiting
• Conditions: Pain; Edema Leg

Detailed Description

Transcutaneous Electrical Nerve Stimulation (TENS) is used for the treatment of various acute and chronic pain conditions. It has been shown to increase participation by providing pain control in the rehabilitation of patients undergoing surgery. Evidence is accumulating that it improves patient comfort and reduces the use of analgesic medication in the early postoperative period, so TENS is included in postoperative pain management guidelines.

On the other hand, peripheral blocks have become the preferred method of anesthesia in order to avoid the complications of general anesthesia. When adjusting TENS amplitude for postoperative pain control in these patients, either low amplitudes are preferred or for the amplitude adjustment as a reference, the contralateral side without block is used.

Cautious application is recommended in patients with sensory impairment, impaired cognitive functions, and pediatric patients. In such cases, it is preferable to use TENS at low amplitudes to avoid complications in daily practice. However, using the contralateral extremity as a reference may cause undesirable results as the electrical resistance of the edematous tissue may change.

In this study, it was aimed to compare the amplitude settings of three different frequency TENS modes (Conventional TENS, LF TENS, HF TENS) in patients who had undergone total knee arthroplasty, both in the preoperative state and with the contralateral knee.

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Aynur Basaran, MD, Prof; Phone Number: +90 338 226 3225; Email: aynurbasaran@gmail.com
• Study Contact Backup: Name: Yurdagul Bahran Mustu, MD; Email: yurdagulbahran@gmail.com

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Recruiting
    • Karaman Training and Research Hospital
    • Contact: Aynur Basaran; Phone Number: +90 338 226 3225; Email: aynurbasaran@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who applied to Karaman Training and Research Hospital Orthopedics and Traumatology Polyclinic and were planned for unilateral knee arthroplasty

Description

Inclusion Criteria:

• Age ≥ 40 years
• Patients undergoing unilateral total knee arthroplasty

Exclusion Criteria:

• Patients with scars in any of both knee areas
• Patients who have previously had surgery on the control leg
• Patients undergoing surgery due to trauma or cancer
• Patients with sensory impairments
• Patients with excessive effusion and edema in the knee joints before the surgery (eg. Inflammatory arthropathy, gonarthrosis exacerbation, etc.)
• Mental impairment, or poor general health status that would interfere with assessments during TENS application.
• Any contraindication for TENS (allergy to the TENS electrodes, skin conditions or skin sensation impairment in the areas where the electrodes will be placed, pacemaker or other implanted electrical device, epilepsy, pregnancy)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in amplitudes of the conventional TENS mode between pre- and post-arthroplasty measurements	Univariate statistical analyses will be performed to calculate differences in amplitudes of the conventional TENS mode between pre- and post-arthroplasty measurements on both knees and between knees	2-3 days
The difference in amplitudes of the high frequency TENS mode between pre- and post-arthroplasty measurements	Univariate statistical analyses will be performed to calculate differences in amplitudes of the high frequency TENS mode between pre- and post-arthroplasty measurements on both knees and between knees	2-3 days
The difference in amplitudes of the low frequency TENS mode between pre- and post-arthroplasty measurements	Univariate statistical analyses will be performed to calculate differences in amplitudes of the low frequency TENS mode between pre- and post-arthroplasty measurements on both knees and between knees	2-3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of the amount of edema on the amplitudes of TENS modes	Primary study results found to be significant in univariate analysis will be checked for correlation with the amount of edema in the operated knee	2-3 days
The effect of the type of anesthesia applied on the amplitudes of TENS modes	Primary study results found to be significant in univariate analysis will be tested with post-hoc analysis whether the type of anesthesia applied has any effect	203 days

Collaborators and Investigators

• Sponsor: Karamanoğlu Mehmetbey University
• Collaborators: Karaman Training and Research Hospital
• Investigators: Principal Investigator: Aynur Basaran, MD,Prof, Karaman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2023
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Arthroplasty; Transcutaneous electrical nerve stimulation; Amplitude adjustment
• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: E-11095095-050.01.04-154037

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No