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Completed

NCT Number: NCT05470244

TENS 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.

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Key information

Conditions

Total Knee Arthoplasty Knee Pain

Age range

31 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Pain Intensity

    Time frame: 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

  2. Rang of Motion

    Time frame: 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

  3. Intra-venous analgesic requirement

    Time frame: 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 outcomes

  1. Length of Hospital Stay

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2022
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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