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

NCT ID: NCT05470244

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-13
• Study Completion Date: 2022-12-15

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.

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.

Conditions

Total Knee Arthoplasty; Knee Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Therapeutic Exercise Group

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

Group Type: ACTIVE_COMPARATOR

Routine Physical Therapy and Intra-venous analgesic regimen

Intervention Type: 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

TENS Plus Therapeutic Exercise Group

This group will receive high frequency Transcutaneous Electrical Nerve Stimulation with routine physical therapy and prescribed intra-venous regimen.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 31 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Ayesha Jamil

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof. Dr. Ashfaq Ahmed, PhD

Role: STUDY_DIRECTOR

University of Lahore

Locations

The University of Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

TKR

Identifier Type: -

Identifier Source: org_study_id