Does Edema Affect the Adjustment of TENS Amplitude

Pain Clinical Trial

Official title:

Does Edema After Knee Arthroplasty Affect the Adjustment of TENS Amplitude

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153277
• Other study ID #: E-11095095-050.01.04-154037
• Status: Recruiting
• Start date: December 7, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Karamanoglu Mehmetbey University
• Contact: Aynur Basaran, MD, Prof
• Phone: +90 338 226 3225
• Email: aynurbasaran[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Edema
• Edema Leg
• Pain

Locations

Country	Name	City	State
Turkey	Karaman Training and Research Hospital	Karaman

Sponsors (2)

Lead Sponsor	Collaborator
Karamanoglu Mehmetbey University	Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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