Photobiomodulation Therapy in Patients Receiving Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

A Randomized Trial of Photobiomodulation Effect in Patients Receiving Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06426251
• Other study ID #: 111-036-F
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: Hsiang-Chieh Hsieh
• Phone: 886972654075
• Email: thungjay2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• total knee arthroplasty

Exclusion Criteria:

• open injury

• pregnancy

• wound without primary closure

• infection

• previous surgery over surgical site

• skin defect

Related Conditions & MeSH terms

• Inflammation
• Osteoarthritis
• Pain, Postoperative
• Post Operative Pain

Intervention

Device:
• Photobiomodulation
Photobiomodulation therapy will be given daily start on the first day after surgery to post operative day 6

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Hsin-Chu Branch	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

de Rezende MU, Varone BB, Martuscelli DF, Ocampos GP, Freire GMG, Pinto NC, de Sousa MVP. Pilot study of the effect of therapeutic photobiomodulation on postoperative pain in knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):159-161. doi: 10.1016/j.bjane.2021.07.040. Epub 2021 Nov 17. — View Citation

Vassao PG, Renno AC, Smith BN, Bennett GB, Murphy M, Liebert A, Chow R, Laakso EL. Pre-Conditioning and Post-Operative Photobiomodulation Therapy by a Novel Light Patch System for Knee Arthroplasty: A Protocol for a Phase 1 Study. Photobiomodul Photomed Laser Surg. 2020 Apr;38(4):206-214. doi: 10.1089/photob.2019.4751. Epub 2020 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of bioimpedance	bioimpedance of the surgical site will be measured for evaluation of swelling change	the bioimpedance measured once daily since post operative day1 to day6 and at 2 weeks
Secondary	pain score (visual analogue score)	patient reported pain score, from 0 to 100 points	once daily since post operative day1 to day6
Secondary	active range of motion of knee	active range of motion of knee	once daily since post operative day1 to day6
Secondary	2 minute walk test	the distance that the patient could walk within 2 minutes	once daily since post operative day1 to day6