Edema LegNCT06153277
Does Edema Affect the Adjustment of TENS Amplitude
An observational study of Edema Leg and Pain, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Dec 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who applied to Karaman Training and Research Hospital Orthopedics and Traumatology Polyclinic and were planned for unilateral knee arthroplasty
Who may be able to join
- Age ≥ 40 years
- Patients undergoing unilateral total knee arthroplasty
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yurdagul Bahran Mustu, MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karaman Training and Research Hospital
Karaman, 70200
Aynur Basaran, +90 338 226 3225, aynurbasaran@gmail.com
About this study
Official title: 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.
Read the 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.
- Keywords
- Transcutaneous electrical nerve stimulation, Amplitude adjustment, Arthroplasty
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 2-3 days
Secondary outcomes (2)
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
Measured: 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
Measured: 203 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start7 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edema LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Responsible party
- Principal investigator, Aynur Başaran, Karamanoğlu Mehmetbey University
- Investigators
- Aynur Basaran, MD,Prof, Principal investigator, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153277
- Sponsor's protocol ID
- 09-2023/01
- Status last verified
- Aug 2026
- First submitted
- 22 Nov 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Edema After Knee Arthroplasty Affect the Adjustment of TENS Amplitude
- ClinicalTrials.gov ID
- NCT06153277
- Acronym / sponsor ID
- 09-2023/01
- Keywords
- Transcutaneous electrical nerve stimulation, Amplitude adjustment, Arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who applied to Karaman Training and Research Hospital Orthopedics and Traumatology Polyclinic and were planned for unilateral knee arthroplasty
Key inclusion criteria (2 listed)
- Age ≥ 40 years
- Patients undergoing unilateral total knee arthroplasty
Key exclusion criteria (7 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference in amplitudes of the conventional TENS mode between pre- and post-arthroplasty measurements
Time frame: 2-3 days
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
Time frame: 2-3 days
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
Time frame: 2-3 days
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 secondary outcomes
The effect of the amount of edema on the amplitudes of TENS modes
Time frame: 2-3 days
The effect of the type of anesthesia applied on the amplitudes of TENS modes
Time frame: 203 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yurdagul Bahran Mustu, MD contact
Aynur Basaran, MD,Prof principal investigator
Karaman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edema Leg and Pain, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aynur Basaran, MD, Prof (+90 338 226 3225, aynurbasaran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in amplitudes of the conventional TENS mode between pre- and post-arthroplasty measurements (time frame: 2-3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.