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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05470244
Other study ID # TKR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 13, 2022
Est. completion date December 15, 2022

Study information

Verified date April 2023
Source University of Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 15, 2022
Est. primary completion date December 15, 2022
Accepts healthy volunteers No
Gender All
Age group 31 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Pakistan The University of Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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
Primary 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 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
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