Total Knee ReplacementNCT07155837
The Effect of TENS on Early Patient Outcomes After Total Knee Arthroplasty
A study testing TENS group in people with Total Knee Replacement, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of TENS on Early Outcomes in Incisional Wounds After Total Knee Replacement Incisional wounds heal within 3 to 4 weeks, consistent with the normal healing process. However, pain is experienced during the wound healing phase, which can negatively impact patients' recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- TENS group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 15 Sep 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are over 18 years of age, A first-time total knee arthroplasty, No psychological distress, Able to communicate effectively, No history of chronic pain, Oriented to person, place, and time, Physician-approved, and have no contraindications to TENS (no pacemaker, no arrhythmia, no epilepsy, etc.), Agree to participate in the study.
Who cannot join
- Patients with metastatic disease, Alcohol, drug, or substance abuse, Have other incisions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Adana Şehir Eğitim ve Araştırma Hastanesi
Adana, Adana, 01030
About this study
The Effect of TENS on Early Outcomes in Incisional Wounds After Total Knee Replacement Incisional wounds heal within 3 to 4 weeks, consistent with the normal healing process.
However, pain is experienced during the wound healing phase, which can negatively impact patients' recovery. Pharmacological and non-pharmacological methods are used to control pain in the early postoperative period. TENS, in particular, is notable as a non-invasive method, aiming to alleviate pain with low-voltage electrical currents. Studies report that TENS significantly reduces postoperative incisional wound pain. However, the literature demonstrates a limited number of studies on comprehensive pain assessment of incisional wounds using TENS. However, because postoperative incision pain negatively impacts patient outcomes (e.g., pain, mobilization, coughing, sleep), the effectiveness of the analgesia method must be measured. Early pain should be comprehensively assessed to plan effective treatments and improve patient recovery. In this context, the aim of the study was to evaluate the effect of TENS on early pain management in incisional wounds after total knee replacement. The study was designed as a randomized controlled trial. Patients meeting the study's sample criteria will be included. Data collection tools will be a Personal Information Form and the Revised American Pain Society Patient Outcomes Questionnaire (GGAADHSA), which measures the patient's pain assessment in the first 24 hours. TENS will be applied twice (12 hours apart) for 30 minutes each time within the first 24 hours after surgery to the experimental group, while the control group will receive standard treatment. The GGAADHSA questionnaire will be administered once to both groups 24 hours later. The study will evaluate the effect of TENS on early patient outcomes in incisional wounds and contribute to clinical practice in terms of postoperative recovery.
- Conditions
- Total Knee Replacement
- Being tested
- TENS group
- Keywords
- TENS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS groupDevice
The intervention group received TENS twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Kontrol Grubu | Experimental | Not described Receives: Device: TENS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial 24-hour pain assessment with the Revised American Pain Society Patient Outcomes Questionnaire (GGAADHSA).
This questionnaire measures multidimensional patient outcomes such as pain intensity, impact of pain on daily life (mobilization, sleep, coughing, etc.), and satisfaction with analgesia.
Measured: 12 ay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Dec 2024
- Primary completion1 Jan 2025
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdurrahman ACAR, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155837
- Sponsor's protocol ID
- ÇukurovaACAR001
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 4 Sep 2025
- 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of TENS on Early Patient Outcomes After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07155837
- Acronym / sponsor ID
- ÇukurovaACAR001
- Conditions
- Total Knee Replacement
- Keywords
- TENS
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 4 Sep 2025 (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 Effect of TENS on Early Outcomes in Incisional Wounds After Total Knee Replacement Incisional wounds heal within 3 to 4 weeks, consistent with the normal healing process.
However, pain is experienced during the wound healing phase, which can negatively impact patients' recovery. Pharmacological and non-pharmacological methods are used to control pain in the early postoperative period. TENS, in particular, is notable as a non-invasive method, aiming to alleviate pain with low-voltage electrical currents. Studies report that TENS significantly reduces postoperative incisional wound pain. However, the literature demonstrates a limited number of studies on comprehensive pain assessment of incisional wounds using TENS. However, because postoperative incision pain negatively impacts patient outcomes (e.g., pain, mobilization, coughing, sleep), the effectiveness of the analgesia method must be measured. Early pain should be comprehensively assessed to plan effective treatments and improve patient recovery. In this context, the aim of the study was to evaluate the effect of TENS on early pain management in incisional wounds after total knee replacement. The study was designed as a randomized controlled trial. Patients meeting the study's sample criteria will be included. Data collection tools will be a Personal Information Form and the Revised American Pain Society Patient Outcomes Questionnaire (GGAADHSA), which measures the patient's pain assessment in the first 24 hours. TENS will be applied twice (12 hours apart) for 30 minutes each time within the first 24 hours after surgery to the experimental group, while the control group will receive standard treatment. The GGAADHSA questionnaire will be administered once to both groups 24 hours later. The study will evaluate the effect of TENS on early patient outcomes in incisional wounds and contribute to clinical practice in terms of postoperative recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kontrol Grubu | Experimental | Device: TENS group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are over 18 years of age, A first-time total knee arthroplasty, No psychological distress, Able to communicate effectively, No history of chronic pain, Oriented to person, place, and time, Physician-approved, and have no contraindications to TENS (no pacemaker, no arrhythmia, no epilepsy, etc.), Agree to participate in the study.
Key exclusion criteria (1 listed)
- Patients with metastatic disease, Alcohol, drug, or substance abuse, Have other incisions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENS groupThe intervention group received TENS twice a day. | Device | Kontrol Grubu |
Primary outcome
Initial 24-hour pain assessment with the Revised American Pain Society Patient Outcomes Questionnaire (GGAADHSA).
Time frame: 12 ay
This questionnaire measures multidimensional patient outcomes such as pain intensity, impact of pain on daily life (mobilization, sleep, coughing, etc.), and satisfaction with analgesia.
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 4 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS group in people with Total Knee Replacement, run by Cukurova 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 4 Sep 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial 24-hour pain assessment with the Revised American Pain Society Patient Outcomes Questionnaire (GGAADHSA). (time frame: 12 ay). 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 4 Sep 2025.