TENS in Post-operative Total Knee Arthroplasty Recovery and Intra-venous Analgesics Requirement

Study Overview
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Brief Summary
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Total knee arthroplasty (TKA) is among the major advancements for the treatment of knee pain and improvement of physical function when conservative management fails to comply with. The success of this arthoplasty results in more functional mobility and better quality of life. However, management of pain after TKA in post-operative period is a big challenge to deal.

Detailed Description
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Transcutaneous electrical nerve stimulation is a cost effective, non-invasive electrotherapeutic modality used in alleviating pain in both acute and chronic conditions affecting neuromusculoskeletal system of the body.

Official Title
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Effects of Transcutaneous Electrical Nerve Stimulation in Post-operative Total Knee Arthroplasty Recovery and Intra-venous Analgesics Requirement

Conditions
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Total Knee Arthoplasty, Knee Pain

Intervention / Treatment
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* Other: Routine Physical Therapy and Intra-venous analgesic regimen
* Other: Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both male and female Aged between 31-70 years Total Knee Arthoplasty, who had been diagnosed with knee osteoarthritis, inflammatory arthritis, trauma, fracture result in total knee arthoplasty. Exclusion Criteria: Any allergic condition of skin Chronic consumption of opioids History of dysplasia or malignancy to knee joint Any major bone operation of lower limb BMI higher than 35 kg m-2 History of mental disorder Neurological illness e.g. Alzheimer which might interfere with assessment process.

Ages Eligible for Study
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Minimum Age: 31 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Therapeutic Exercise Group<br>This group will receive Routine Physical therapy protocol along with prescribed intra-venous regimen. | Other: Routine Physical Therapy and Intra-venous analgesic regimen<br>* ROM Exercises will be performed and analgesics including the NSAIDs and narcotics as per prescription of surgeon/physician will be given to all subjects<br>|
| Experimental: TENS Plus Therapeutic Exercise Group<br>This group will receive high frequency Transcutaneous Electrical Nerve Stimulation with routine physical therapy and prescribed intra-venous regimen. | Other: Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimen<br>* High frequency stimulations via Transcutaneous Electrical Nerve Simulator will be applied. ROM Exercises will be performed and analgesics including the NSAIDs and narcotics as per prescription of surgeon/physician will be given to all subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Pain intensity will be measured using Visual Analogue Scale | Pain intensity will be measured at baseline,and change in pain intensity will be measured from baseline to 24 hour, 48 hour and 72 hours. | 
| Rang of Motion | Knee Rang of Motion will be measured using Universal Goniometer | Knee Range of Motion will be measured at baseline, and Change in Knee Range of Motion will be measured from baseline to 24 hour, 48 hour and 72 hours | 
| Intra-venous analgesic requirement | Dose and frequency of intravenous analgesic requirement will be observed through Patient's file | Analgesics requirement will be observed at first post-operative day, at second post-operative day, at third post-operative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay | Length of Hospital Stay of patient | It will be measured from the time of randomization till the time of discharge from hospital upto ten days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthoplasty, Knee Pain, Post-operative, Transcutaneous electrical nerve stimulation, Intra-venous, Analgesics requirement, Recovery