An observational study in Edema Leg and Pain, sponsored by Karamanoğlu Mehmetbey University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Karamanoğlu Mehmetbey University · Observational
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.
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.
2,219 studies on the registry are indexed under Pain; 915 are open to participants now.
This study's planned enrollment of 125 is above the median of 107 across 270 observational studies indexed under Pain.
Browse Pain studies →Karamanoğlu Mehmetbey University is the lead sponsor of 65 studies on the registry; 18 are open to participants now.
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Patients who applied to Karaman Training and Research Hospital Orthopedics and Traumatology Polyclinic and were planned for unilateral knee arthroplasty
Exclusion Criteria:
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
Time frame: 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
Time frame: 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
Time frame: 2-3 days
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
Time frame: 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
Time frame: 203 days
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Karamanoğlu Mehmetbey University