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

Knee Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05470244
• Other study ID #: TKR
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Knee Pain

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