Total Knee ReplacementNCT05115565
The Effects of Transcutaneous Electrical Nerve Stimulation in Patients With Total Knee Replacement
A study testing TENS (Transcutaneous Electrical Nerve Stimulation) Application in people with Total Knee Replacement and Transcutaneous Electrical Nerve Stimulation, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
Total Knee Replacement (TDP) is considered the best treatment option available when conservative methods such as anti-inflammatory or physical therapy fail. However, TDP surgeries are also a serious trauma that causes severe pain in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement, Transcutaneous Electrical Nerve Stimulation, Total Knee Replacement Surgery
- What is being tested?
- TENS (Transcutaneous Electrical Nerve Stimulation) Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Not have had knee replacement surgery before,
- Having unilateral prosthesis surgery,
- Not having a pacemaker or arrhythmia,
- Not having neurological deficit,
- Absence of sensory loss, paresthesia or hyporeflexia,
- Not having local or systemic infection,
Show all 19Show fewer
- Not using opioids or TENS before surgery,
- Not having history of chronic pain,
- Not having history of alcohol or drug use,
- Not having a psychiatric history,
- Not having been done to apply epidural analgesia in the postoperative period,
- Not having serious complications after surgery,
- Not having a history of neurological disease (SVO, epilepsy, dementia, etc.),
- Not having active tumor or cancer,
- Not having fractures or dislocations,
- Absence of signs of venous thromboembolism,
- Having an ASA score of I and II,
- Agree to participate in the research and
- Know how to read and write
Who cannot join
- Undergoing previous knee replacement surgery,
- Having double-sided prosthesis surgery,
- Having a pacemaker and arrhythmia,
- Having a neurological deficit,
- Having loss of sensation, paresthesia or hyporeflexia,
- Having local or systemic infection,
Show all 19Show fewer
- Having been used opioids and or TENS before surgery,
- Having a history of chronic pain,
- Having a history of alcohol or drug use,
- Having a psychiatric history,
- Administering epidural analgesia in the postoperative period,
- Developing serious complications after surgery,
- Having a history of neurological disease (SVO, epilepsy, dementia, etc.),
- Having an active tumor or cancer,
- Having fracture or dislocation,
- Having symptoms of venous thrombosis,
- Not having ASA score I or II,
- Not agreeing to participate in the study,
- Illiteracy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yozgat Bozok University Research and Application Hospital
Yozgat, Merkez, 66100
Nilgün Özbaş, Assist Prof, +90-354- 314- 14- 15 ext. 1049, nilgun.ozbas06@gmail.com
Murat Korkmaz, Professor, +90-532-303-47-72, doktormuratkorkmaz@hotmail.com
About this study
Official title: The Effect of Transcutaneous Electrical Nerve Stimulation on Pain, Functionality and Quality of Life in Patients With Total Knee Replacement
Total Knee Replacement (TDP) is considered the best treatment option available when conservative methods such as anti-inflammatory or physical therapy fail. However, TDP surgeries are also a serious trauma that causes severe pain in patients. Uncontrollable pain exacerbates the stress response and causes morbidity and mortality by causing negative changes in the neuroendocrine, respiratory, cardiovascular, gastrointestinal, renal and immune systems. Therefore, the relief of pain has very important effects on the patient's recovery process, functional status and quality of life. Transcutaneous Electrical Nerve Stimulation (TENS) is one of the non-pharmacological methods for pain relief in TDP surgeries. This study was planned as a randomized controlled trial to examine the effects of TENS after TDP on acute pain, functionality and quality of life.
Read the detailed description
Nowadays, it is seen that the results of an increasing number of TDP surgeries increase patient satisfaction and have satisfactory results. However, TDP surgery is a serious trauma that causes pain in patients.
TENS is an easy-to-apply, inexpensive, noninvasive, noninvasive method that uses electrical current to activate nerves with therapeutic effects in the treatment of acute and chronic pain. It is also seen as a promising practice in patients undergoing total knee replacement surgery by the American Society of Regional Anesthesia and Pain Medicine (ASRA) and the European Society of Regional Anaesthesia and Pain Therapy (ESRA).
The study was planned as a randomized controlled study to examine the effect of TENS on acute pain, functionality and quality of life after TDP. The hypotheses of the study; H1a- TENS applied after TDP positively affects the level of pain in patients. H1b- TENS applied after TDP affects the improvement in functional status in patients.
H1c- TENS applied after TDP reduces the analgesia consumption of patients. H1d- TENS applied after TDP positively affects the quality of life of patients. Type of Study: Randomized controlled trial. Method: 52 patients (26 controls, 26 interventions) who underwent total knee replacement surgery will be randomized and divided into two groups as intervention and control groups. TENS will be applied to the intervention group in addition to the routine treatment and care in the clinic, on the other hand, no intervention will be made to the control group other than routine treatment and care. Data will be collected with Patient identification form, Pain Evaluation Form, Visual Analogue Scale (VAS), Analgesic Drug Tracking Form, Joint Range of Motion (ROM) Follow-up Form, Western Ontario and McMaster Universities Arthritis Index (WOMAC), Quality of Life Scale (SF-36).
While evaluating the data, it is planned to be analyzed as randomized.It is planned to use multiple completion methods when there are missing data.Statistical analyzes are planned to be evaluated with the SPSS-24 package program. It is planned to use frequency charts and descriptive statistics in order to interpret the data, parametric techniques for normal distributions and non-parametric techniques for non-normal distributions.
- Conditions
- Total Knee Replacement, Transcutaneous Electrical Nerve Stimulation, Total Knee Replacement Surgery
- Being tested
- TENS (Transcutaneous Electrical Nerve Stimulation) Application
- Keywords
- Total knee replacement, Transcutaneous Electrical Nerve Stimulation, Pain, Nursing, Quality of life
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS (Transcutaneous Electrical Nerve Stimulation) ApplicationDevice
Conventional (traditional) TENS will be applied to the patients. The frequency will be 100 Hz, the pulse width (time) will be 150 μs, the current intensity (amplitude) will be 30 mA. In addition to routine care and treatment, TENS will be applied to intervention group patients.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | When the patients are admitted to the clinic, the patient identification form and the SF-36 Quality of Life Scale will be filled by face-to-face interview method. On the morning of the operation, before the operation, the GCS, EHA and WOMAC index will be filled. After the operation, the pain during rest and movement (24., 48., 72., 96. hours and 15. days) will be evaluated with VAS. The total amount of analgesics used by the patients will be recorded by looking at the nurse observation form records where the nurses recorded the drugs they administered at the 24th, 48th, 72nd, and 96th hours after the surgery, and by asking the patients on the 15th day after discharge. The WOMAC Index will be re-administered at discharge and on the 15th day, and the VCS, ROM, and the SF-36 Quality of Life Scale on the 15th day. |
| Intervention group | Experimental | Unlike the control group, the patients in the intervention group will be informed about TENS and the application will be made. The electrodes of TENS will be placed 2 cm below and 2 cm above the incision site. TENS settings Frequency: 100 Hz; Pulse width (duration): 150 μs; Flow Intensity (Amplitude): By adjusting it to be 30 mA, TENS will be applied 3 times a day (09.00, 13.00, 17.00) for 20 minutes during the time the patients stay in the clinic (3 days).It is planned to start the TENS application the day after the surgery. Receives: Device: TENS (Transcutaneous Electrical Nerve Stimulation) Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) Change
The Visual Analogue Scale (VAS) is a scale where the pain is evaluated between 0-10 (0; no pain, 10; unbearable pain) on a ruler that can be used horizontally or vertically, on which the patient can mark his or her own pain.The length of the distance from the point where there is no pain to the point marked by the patient is measured in centimeters and the numerical value found shows the severity of the patient's pain. It is used in various populations, including patients with total knee replacement, to evaluate both the severity of pain and the effectiveness of treatment/intervention on pain.
Measured: 1st day of admission to the clinic change VAS score at before intervention, 24th postoperative hour change from baseline VAS score before the intervention, postoperative 48th, 72th and 96th hours,15th day change from baseline VAS score after intervention
Secondary outcomes (2)
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Change
WOMAC is planned to be used to assess functionality in patients.The score to be taken from the scale is between 0-100. An increase in score indicates deterioration in physical function.
The WOMAC index is a valid and reliable index that is widely used for the evaluation of patients with osteoarthritis. The index consists of three parts and 24 questions in which pain, stiffness and physical function are questioned. Each question was scored according to the Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. The score of each section is calculated in itself and the total score varies between 0 and 100. High scores indicate an increase in pain and stiffness, and deterioration in physical function.
Measured: 1st day of admission to the clinic change WOMAC score at before intervention, change from baseline the WOMAC score at 4th postoperative day, 15th postoperative day change from baseline WOMAC score
The Quality of Life Scale (SF-36) Change
The Quality of Life Scale (SF-36), one of the most used scales to measure quality of life; It is a self-assessment scale that can be filled in a short time and is highly sensitive.While applying the scale, individuals are asked to answer considering the last 4 weeks. The scale consists of 36 questions and 8 sub-parameters (body pain, limitation due to physical problems, limitation due to mental problems, mental well-being, fatigue, general health perception, social function and physical function). In scoring, each parameter is evaluated between 0 and 100 points. A score of 0 indicates poor health, and a score of 100 indicates good health. The higher the score, the higher the quality of life.
Measured: 1st day of admission to the clinic change quality of life score at before intervention, 15th postoperative day change from baseline quality of life score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start15 Nov 2021 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Nov 2022 (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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgun Ozbas, Bozok University
- Investigators
- Nilgün Özbaş, Assist. Prof, Principal investigator, Bozok UniversityEmre Ersoy, Assist. Prof, Study chair, Bozok UniversityHacı Ali Olçar, Doctor, Study chair, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115565
- Sponsor's protocol ID
- 2017-KAEK-189_2021.09.22_05
- Status last verified
- Oct 2021
- First submitted
- 5 Sep 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Nerve Stimulation on Pain, Functionality and Quality of Life in Patients With Total Knee Replacement
- ClinicalTrials.gov ID
- NCT05115565
- Acronym / sponsor ID
- 2017-KAEK-189_2021.09.22_05
- Conditions
- Total Knee Replacement, Transcutaneous Electrical Nerve Stimulation, Total Knee Replacement Surgery
- Keywords
- Total knee replacement, Transcutaneous Electrical Nerve Stimulation, Pain, Nursing, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 10 Nov 2021 (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.
Total Knee Replacement (TDP) is considered the best treatment option available when conservative methods such as anti-inflammatory or physical therapy fail. However, TDP surgeries are also a serious trauma that causes severe pain in patients. Uncontrollable pain exacerbates the stress response and causes morbidity and mortality by causing negative changes in the neuroendocrine, respiratory, cardiovascular, gastrointestinal, renal and immune systems. Therefore, the relief of pain has very important effects on the patient's recovery process, functional status and quality of life. Transcutaneous Electrical Nerve Stimulation (TENS) is one of the non-pharmacological methods for pain relief in TDP surgeries. This study was planned as a randomized controlled trial to examine the effects of TENS after TDP on acute pain, functionality and quality of life.
Detailed description
Nowadays, it is seen that the results of an increasing number of TDP surgeries increase patient satisfaction and have satisfactory results. However, TDP surgery is a serious trauma that causes pain in patients.
TENS is an easy-to-apply, inexpensive, noninvasive, noninvasive method that uses electrical current to activate nerves with therapeutic effects in the treatment of acute and chronic pain. It is also seen as a promising practice in patients undergoing total knee replacement surgery by the American Society of Regional Anesthesia and Pain Medicine (ASRA) and the European Society of Regional Anaesthesia and Pain Therapy (ESRA).
The study was planned as a randomized controlled study to examine the effect of TENS on acute pain, functionality and quality of life after TDP. The hypotheses of the study; H1a- TENS applied after TDP positively affects the level of pain in patients. H1b- TENS applied after TDP affects the improvement in functional status in patients.
H1c- TENS applied after TDP reduces the analgesia consumption of patients. H1d- TENS applied after TDP positively affects the quality of life of patients. Type of Study: Randomized controlled trial. Method: 52 patients (26 controls, 26 interventions) who underwent total knee replacement surgery will be randomized and divided into two groups as intervention and control groups. TENS will be applied to the intervention group in addition to the routine treatment and care in the clinic, on the other hand, no intervention will be made to the control group other than routine treatment and care. Data will be collected with Patient identification form, Pain Evaluation Form, Visual Analogue Scale (VAS), Analgesic Drug Tracking Form, Joint Range of Motion (ROM) Follow-up Form, Western Ontario and McMaster Universities Arthritis Index (WOMAC), Quality of Life Scale (SF-36).
While evaluating the data, it is planned to be analyzed as randomized.It is planned to use multiple completion methods when there are missing data.Statistical analyzes are planned to be evaluated with the SPSS-24 package program. It is planned to use frequency charts and descriptive statistics in order to interpret the data, parametric techniques for normal distributions and non-parametric techniques for non-normal distributions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –When the patients are admitted to the clinic, the patient identification form and the SF-36 Quality of Life Scale will be filled by face-to-face interview method. On the morning of the operation, before the operation, the GCS, EHA and WOMAC index will be filled. After the operation, the pain during rest and movement (24., 48., 72., 96. hours and 15. days) will be evaluated with VAS. The total amount of analgesics used by the patients will be recorded by looking at the nurse observation form records where the nurses recorded the drugs they administered at the 24th, 48th, 72nd, and 96th hours after the surgery, and by asking the patients on the 15th day after discharge. The WOMAC Index will be re-administered at discharge and on the 15th day, and the VCS, ROM, and the SF-36 Quality of Life Scale on the 15th day. |
| Intervention group | Experimental | Device: TENS (Transcutaneous Electrical Nerve Stimulation) ApplicationUnlike the control group, the patients in the intervention group will be informed about TENS and the application will be made. The electrodes of TENS will be placed 2 cm below and 2 cm above the incision site. TENS settings Frequency: 100 Hz; Pulse width (duration): 150 μs; Flow Intensity (Amplitude): By adjusting it to be 30 mA, TENS will be applied 3 times a day (09.00, 13.00, 17.00) for 20 minutes during the time the patients stay in the clinic (3 days).It is planned to start the TENS application the day after the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Not have had knee replacement surgery before,
- Having unilateral prosthesis surgery,
- Not having a pacemaker or arrhythmia,
- Not having neurological deficit,
- Absence of sensory loss, paresthesia or hyporeflexia,
Key exclusion criteria (19 listed)
- Undergoing previous knee replacement surgery,
- Having double-sided prosthesis surgery,
- Having a pacemaker and arrhythmia,
- Having a neurological deficit,
- Having loss of sensation, paresthesia or hyporeflexia,
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 (Transcutaneous Electrical Nerve Stimulation) ApplicationConventional (traditional) TENS will be applied to the patients. The frequency will be 100 Hz, the pulse width (time) will be 150 μs, the current intensity (amplitude) will be 30 mA. In addition to routine care and treatment, TENS will be applied to intervention group patients. | Device | Intervention group |
Primary outcome
Visual Analogue Scale (VAS) Change
Time frame: 1st day of admission to the clinic change VAS score at before intervention, 24th postoperative hour change from baseline VAS score before the intervention, postoperative 48th, 72th and 96th hours,15th day change from baseline VAS score after intervention
The Visual Analogue Scale (VAS) is a scale where the pain is evaluated between 0-10 (0; no pain, 10; unbearable pain) on a ruler that can be used horizontally or vertically, on which the patient can mark his or her own pain.The length of the distance from the point where there is no pain to the point marked by the patient is measured in centimeters and the numerical value found shows the severity of the patient's pain. It is used in various populations, including patients with total knee replacement, to evaluate both the severity of pain and the effectiveness of treatment/intervention on pain.
2 secondary outcomes
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Change
Time frame: 1st day of admission to the clinic change WOMAC score at before intervention, change from baseline the WOMAC score at 4th postoperative day, 15th postoperative day change from baseline WOMAC score
The Quality of Life Scale (SF-36) Change
Time frame: 1st day of admission to the clinic change quality of life score at before intervention, 15th postoperative day change from baseline quality of life score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nilgün Özbaş, Assist. Prof principal investigator
Bozok University
Emre Ersoy, Assist. Prof study chair
Bozok University
Hacı Ali Olçar, Doctor study chair
Bozok University
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 (Transcutaneous Electrical Nerve Stimulation) Application in people with Total Knee Replacement and Transcutaneous Electrical Nerve Stimulation, run by Bozok 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 19 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 10 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nilgün Özbaş, Assist Prof (+90-354- 314- 14- 15 ext. 1049, nilgun.ozbas06@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) Change (time frame: 1st day of admission to the clinic change VAS score at before intervention, 24th postoperative hour change from baseline VAS score before the intervention, postoperative 48th, 72th and 96th hours,15th day change from baseline VAS score after intervention). 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 10 Nov 2021.