Clinical trial NCT05115565: The Effects of Transcutaneous Electrical Nerve Stimulation in Patients With Total Knee Replacement
Official title: The Effect of Transcutaneous Electrical Nerve Stimulation on Pain, Functionality and Quality of Life in Patients With Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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,
* 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

Exclusion Criteria:

* 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,
* 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

Primary outcomes:
measure: Visual Analogue Scale (VAS) Change
timeFrame: 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:
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Change
timeFrame: 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
measure: The Quality of Life Scale (SF-36) Change
timeFrame: 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
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Yozgat Bozok University Research and Application Hospital
state: Merkez
Study officials:
affiliation: Bozok University
name: Nilgün Özbaş, Assist. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Bozok University
name: Emre Ersoy, Assist. Prof
role: STUDY_CHAIR
affiliation: Bozok University
name: Hacı Ali Olçar, Doctor
role: STUDY_CHAIR
References: