NCT05115565

The Effects of Transcutaneous Electrical Nerve Stimulation in Patients With Total Knee Replacement

The Effect of Transcutaneous Electrical Nerve Stimulation on Pain, Functionality and Quality of Life in Patients With Total Knee Replacement

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Bozok University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Knee Replacement
• Transcutaneous Electrical Nerve Stimulation
• Total Knee Replacement Surgery

Interventions

Type	Name	Description
DEVICE	TENS (Transcutaneous Electrical Nerve Stimulation) Application	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.

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-08-30
• Completion: 2022-11-30
• First posted: 2021-11-10
• Last updated: 2021-11-10

Locations

1 site across 1 country: Turkey (Türkiye)