Total Knee Replacement Clinical Trial
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04040985 -
Legion Primary Safety and Efficacy
|
N/A | |
Recruiting |
NCT05279092 -
Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study
|
Phase 2 | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Not yet recruiting |
NCT04594447 -
Physica System KR vs Physica System CR (K-20)
|
N/A | |
Completed |
NCT02413996 -
Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty
|
N/A | |
Completed |
NCT01500252 -
Patellar Resurfacing Versus Patellar Retention in Total Knee Arthroplasty - A Randomized Clinical Trial
|
Phase 4 | |
Completed |
NCT04081493 -
The Efficacy of Low-load Blood Flow Restricted Resistance Before TKR
|
N/A | |
Active, not recruiting |
NCT03339557 -
Comparison of Three Knee Replacements
|
N/A | |
Enrolling by invitation |
NCT04513145 -
Adductor Canal Block
|
Phase 2/Phase 3 | |
Completed |
NCT06045078 -
Aromatherapy in Total Knee Replacement
|
N/A | |
Completed |
NCT02468934 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System
|
N/A | |
Completed |
NCT02914210 -
Virtual vs. Traditional Physical Therapy Following Total Knee Replacement
|
N/A | |
Withdrawn |
NCT01523418 -
Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)
|
N/A | |
Completed |
NCT00795223 -
Comparative Pain Control Between 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for FNB After TKA
|
Phase 4 | |
Completed |
NCT01307202 -
Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment
|
N/A | |
Completed |
NCT01515449 -
Predictors of Poor Outcomes in 1038 Sigma Knees
|
N/A | |
Completed |
NCT01522781 -
10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis
|
N/A | |
Completed |
NCT04166539 -
Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty
|
||
Completed |
NCT03454256 -
Virtual Reality Rehabilitation in Patients With Total Knee Replacement
|
N/A | |
Enrolling by invitation |
NCT06118073 -
Effect of Mindfulness on Pain After Total Knee Arthroplasty
|
N/A |