Photobiomodulation Therapy in Patients Receiving Total Knee Arthroplasty

May 28, 2024 updated by: National Taiwan University Hospital Hsin-Chu Branch

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Hsinchu, Taiwan
        • Recruiting
        • National Taiwan University Hospital, Hsin-Chu Branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • total knee arthroplasty

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
This group of patient will receive photobiomodulation pads on the part of surgical site and the machine will emit near-infrared light.
Device: Photobiomodulation
Photobiomodulation therapy will be given daily start on the first day after surgery to post operative day 6
Sham Comparator: 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.
Device: Photobiomodulation
Photobiomodulation therapy will be given daily start on the first day after surgery to post operative day 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change of bioimpedance
Time Frame: 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
the bioimpedance measured once daily since post operative day1 to day6 and at 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score (visual analogue score)
Time Frame: once daily since post operative day1 to day6
patient reported pain score, from 0 to 100 points
once daily since post operative day1 to day6
active range of motion of knee
Time Frame: 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
Time Frame: once daily since post operative day1 to day6
the distance that the patient could walk within 2 minutes
once daily since post operative day1 to day6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital Hsin-Chu Branch

Investigators

  • Study Chair: Hsiang-Chieh Hsieh, National Taiwan University Hospital Hsin-Chu Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 2, 2022

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111-036-F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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