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

Not Applicable

Completed

• Conditions: Knee Pain; Total Knee Arthoplasty
• Interventions: Other: Routine Physical Therapy and Intra-venous analgesic regimen; Other: Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimen

• Registration Number: NCT05470244
• Lead Sponsor: University of Lahore

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-07-12
• Study Start: 2022-07-13
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Both male and female
2. Aged between 31-70 years
3. Total Knee Arthoplasty, who had been diagnosed with knee osteoarthritis, inflammatory arthritis, trauma, fracture result in total knee arthoplasty.

Exclusion Criteria

1. Any allergic condition of skin
2. Chronic consumption of opioids
3. History of dysplasia or malignancy to knee joint
4. Any major bone operation of lower limb
5. BMI higher than 35 kg m-2
6. History of mental disorder
7. Neurological illness e.g. Alzheimer which might interfere with assessment process.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic Exercise Group	Routine Physical Therapy and Intra-venous analgesic regimen	This group will receive Routine Physical therapy protocol along with prescribed intra-venous regimen.
TENS Plus Therapeutic Exercise Group	Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimen	This group will receive high frequency Transcutaneous Electrical Nerve Stimulation with routine physical therapy and prescribed intra-venous regimen.

Primary Outcome Measures

Name	Time	Method
Pain Intensity	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.	Pain intensity will be measured using Visual Analogue Scale
Rang of Motion	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	Knee Rang of Motion will be measured using Universal Goniometer
Intra-venous analgesic requirement	Analgesics requirement will be observed at first post-operative day, at second post-operative day, at third post-operative day	Dose and frequency of intravenous analgesic requirement will be observed through Patient's file

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	It will be measured from the time of randomization till the time of discharge from hospital upto ten days	Length of Hospital Stay of patient

Trial Locations

Locations (1)

The University of Lahore; 🇵🇰 Lahore, Punjab, Pakistan