NCT06426251

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
May 2024Dec 2027

First Submitted

Initial submission to the registry

August 2, 2022

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

3.3 years

First QC Date

August 2, 2022

Last Update Submit

May 28, 2024

Conditions

InflammationOsteoarthritisPost Operative Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • pain score (visual analogue score)

    once daily since post operative day1 to day6

  • active range of motion of knee

    once daily since post operative day1 to day6

  • 2 minute walk test

    once daily since post operative day1 to day6

Study Arms (2)

intervention group

EXPERIMENTAL

This group of patient will receive photobiomodulation pads on the part of surgical site and the machine will emit near-infrared light.

Device: Photobiomodulation

control group

SHAM COMPARATOR

This group of patient will have photobiomodulation pads on the body surface as intervention group, but the machine will not emit near-infrared light.

Device: Photobiomodulation

Interventions

PhotobiomodulationDEVICE

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

control groupintervention group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • total knee arthroplasty

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, Hsin-Chu Branch

Hsinchu, Taiwan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 34800495BACKGROUND

  • 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.

    PMID: 32186975BACKGROUND

  • Chia WT, Wong TH, Jaw FS, Hsieh HC. The Impact of Photobiomodulation Therapy on Swelling Reduction and Recovery Enhancement in Total Knee Arthroplasty: A Randomized Clinical Trial. Photobiomodul Photomed Laser Surg. 2025 Feb;43(2):65-72. doi: 10.1089/photob.2024.0120. Epub 2025 Jan 9.

    PMID: 39786308DERIVED

MeSH Terms

Conditions

InflammationOsteoarthritisPain, Postoperative

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPostoperative ComplicationsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Hsiang-Chieh Hsieh

    National Taiwan University Hospital Hsin-Chu Branch

    STUDY CHAIR

Central Study Contacts

Hsiang-Chieh Hsieh

CONTACT

886972654075thungjay2@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2022

First Posted

May 23, 2024

Study Start

May 20, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)