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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • The University of Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Therapeutic Exercise Group; This group will receive Routine Physical therapy protocol along with prescribed intra-venous regimen.	Other: Routine Physical Therapy and Intra-venous analgesic regimen; ROM Exercises will be performed and analgesics including the NSAIDs and narcotics as per prescription of surgeon/physician will be given to all subjects
Experimental: TENS Plus Therapeutic Exercise Group; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Study Director: Prof. Dr. Ashfaq Ahmed, PhD, The University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Knee Pain; Recovery; Post-operative; Transcutaneous electrical nerve stimulation; Total Knee Arthoplasty; Intra-venous; Analgesics requirement
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: TKR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: it will be shared immediately after publication
• IPD Sharing Time Frame: Beginning 9 months and ending on 36th month
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No