Clinical trial NCT06153277: Does Edema Affect the Adjustment of TENS Amplitude
Official title: Does Edema After Knee Arthroplasty Affect the Adjustment of TENS Amplitude
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Edema Leg
Pain
Keywords: Transcutaneous electrical nerve stimulation
Amplitude adjustment
Arthroplasty
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
Collaborators: name: Karaman Training and Research Hospital
First posted: 2023-12-01
Enrollment: 125
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The difference in amplitudes of the conventional TENS mode between pre- and post-arthroplasty measurements
timeFrame: 2-3 days
measure: The difference in amplitudes of the high frequency TENS mode between pre- and post-arthroplasty measurements
timeFrame: 2-3 days
measure: The difference in amplitudes of the low frequency TENS mode between pre- and post-arthroplasty measurements
timeFrame: 2-3 days
Secondary outcomes:
measure: The effect of the amount of edema on the amplitudes of TENS modes
timeFrame: 2-3 days
measure: The effect of the type of anesthesia applied on the amplitudes of TENS modes
timeFrame: 203 days
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Aynur Basaran, MD,Prof
role: PRINCIPAL_INVESTIGATOR
References: