The Effect of Transcutaneous Electrical Nerve Stimulation on Pain, Functionality and Quality of Life in Patients With Total Knee Replacement
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Total Knee Replacement
- Sponsor
- Bozok University
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale (VAS) Change
- Last Updated
- 4 years ago
Overview
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.
Investigators
Nilgun Ozbas
Assistant Professor
Bozok University
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,
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,
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) Change(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(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)