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

NCT05470244 | Completed

• 1 other identifier: TKR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthoplasty; Knee Pain

Keywords

Total Knee Arthoplasty; Knee Pain; Post-operative; Transcutaneous electrical nerve stimulation; Intra-venous; Analgesics requirement; Recovery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Length of Hospital Stay

  It will be measured from the time of randomization till the time of discharge from hospital upto ten days

Study Arms (2)

Therapeutic Exercise Group

ACTIVE COMPARATOR

This group will receive Routine Physical therapy protocol along with prescribed intra-venous regimen.

Other: Routine Physical Therapy and Intra-venous analgesic regimen

TENS Plus Therapeutic Exercise Group

EXPERIMENTAL

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

Interventions

Routine Physical Therapy and Intra-venous analgesic regimen OTHER

ROM Exercises will be performed and analgesics including the NSAIDs and narcotics as per prescription of surgeon/physician will be given to all subjects

Therapeutic Exercise Group

Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimen OTHER

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

TENS Plus Therapeutic Exercise Group

Eligibility Criteria

• Age: 31 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Study Officials

• Prof. Dr. Ashfaq Ahmed, PhD

  University of Lahore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be unaware of the treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 22, 2022
• Study Start: July 13, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending on 36th month

Locations

PA (1)