Photobiomodulation Therapy in Patients Receiving Total Knee Arthroplasty

NCT ID: NCT06426251

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Inflammation Osteoarthritis Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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intervention group

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

Group Type EXPERIMENTAL

Photobiomodulation

Intervention Type DEVICE

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

control group

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

Group Type SHAM_COMPARATOR

Photobiomodulation

Intervention Type DEVICE

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

Interventions

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Photobiomodulation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* total knee arthroplasty

Exclusion Criteria

* open injury
* pregnancy
* wound without primary closure
* infection
* previous surgery over surgical site
* skin defect
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hsiang-Chieh Hsieh

Role: STUDY_CHAIR

National Taiwan University Hospital Hsin-Chu Branch

Locations

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National Taiwan University Hospital, Hsin-Chu Branch

Hsinchu, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsiang-Chieh Hsieh

Role: CONTACT

886972654075

Facility Contacts

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Hsiang-Chieh Hsieh

Role: primary

+886972654075

References

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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.

Reference Type BACKGROUND
PMID: 34800495 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32186975 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39786308 (View on PubMed)

Other Identifiers

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111-036-F

Identifier Type: -

Identifier Source: org_study_id

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