Photobiomodulation Therapy in Patients Receiving Total Knee Arthroplasty

Not Applicable

Recruiting

• Conditions: Osteoarthritis; Inflammation; Post Operative Pain
• Interventions: Device: Photobiomodulation

• Registration Number: NCT06426251
• Lead Sponsor: National Taiwan University Hospital Hsin-Chu Branch

Brief Summary

Photobiomdoulation is the use of near-infrared light to relieve pain, stimulate healing and reduce inflammation. Swelling and inflammation is a common condition after orthopedics surgeries over extremity and spine. This study aim to evaluate the effect of photobiomodulation over patients after Total Knee Arthroplasty.

Detailed Description

Patients aged over 20 after Total Knee Arthroplasty in our institution would be candidate for recruitment. The patients will be randomized to receive routine post operative care or photobiomodulation therapy. The swelling extent and subjective outcome will be recorded.

Study Timeline

• Study First Submitted: 2022-08-02
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-17
• Study Start: 2024-05-20
• Study First Posted: 2024-05-23
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2027-09-01
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• total knee arthroplasty

Exclusion Criteria

• open injury
• pregnancy
• wound without primary closure
• infection
• previous surgery over surgical site
• skin defect

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Photobiomodulation	This group of patient will have photobiomodulation pads on the body surface as intervention group, but the machine will not emit near-infrared light.
intervention group	Photobiomodulation	This group of patient will receive photobiomodulation pads on the part of surgical site and the machine will emit near-infrared light.

Primary Outcome Measures

Name	Time	Method
the change of bioimpedance	the bioimpedance measured once daily since post operative day1 to day6 and at 2 weeks	bioimpedance of the surgical site will be measured for evaluation of swelling change

Secondary Outcome Measures

Name	Time	Method
pain score (visual analogue score)	once daily since post operative day1 to day6	patient reported pain score, from 0 to 100 points
active range of motion of knee	once daily since post operative day1 to day6	active range of motion of knee
2 minute walk test	once daily since post operative day1 to day6	the distance that the patient could walk within 2 minutes

Trial Locations

Locations (1)

National Taiwan University Hospital, Hsin-Chu Branch; 🇨🇳 Hsinchu, Taiwan