About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 40 years
Patients undergoing unilateral total knee arthroplasty
Disqualifiers
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
Trial population
Patients who applied to Karaman Training and Research Hospital Orthopedics and Traumatology Polyclinic and were planned for unilateral knee arthroplasty
Trial design
Case-crossover
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
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
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
Secondary outcomes
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
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
Sponsors and contacts
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Karamanoğlu Mehmetbey University
Lead sponsor
Karaman Training and Research Hospital
Collaborator