InflammationNCT06426251
Photobiomodulation Therapy in Patients Receiving Total Knee Arthroplasty
A study testing Photobiomodulation in people with Inflammation and Osteoarthritis, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Inflammation, Osteoarthritis, Post Operative Pain
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- total knee arthroplasty
Who cannot join
- open injury
- pregnancy
- wound without primary closure
- infection
- previous surgery over surgical site
- skin defect
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital, Hsin-Chu Branch
Hsinchu
Hsiang-Chieh Hsieh, +886972654075, thungjay2@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Inflammation, Osteoarthritis, Post Operative Pain
- Being tested
- Photobiomodulation
- Medical subject headings
- Inflammation, Osteoarthritis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Photobiomodulation therapy will be given daily start on the first day after surgery to post operative day 6
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of bioimpedance
bioimpedance of the surgical site will be measured for evaluation of swelling change
Measured: the bioimpedance measured once daily since post operative day1 to day6 and at 2 weeks
Secondary outcomes (3)
pain score (visual analogue score)
patient reported pain score, from 0 to 100 points
Measured: once daily since post operative day1 to day6
active range of motion of knee
active range of motion of knee
Measured: once daily since post operative day1 to day6
2 minute walk test
the distance that the patient could walk within 2 minutes
Measured: once daily since post operative day1 to day6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start20 May 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiang-Chieh Hsieh, Study chair, National Taiwan University Hospital Hsin-Chu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426251
- Sponsor's protocol ID
- 111-036-F
- Status last verified
- May 2024
- First submitted
- 2 Aug 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34800495Vassao 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.
PubMed 32186975Chia 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.
PubMed 39786308
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Photobiomodulation Effect in Patients Receiving Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06426251
- Acronym / sponsor ID
- 111-036-F
- Conditions
- Inflammation, Osteoarthritis, Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: PhotobiomodulationThis group of patient will receive photobiomodulation pads on the part of surgical site and the machine will emit near-infrared light. |
| control group | Sham comparator | Device: PhotobiomodulationThis group of patient will have photobiomodulation pads on the body surface as intervention group, but the machine will not emit near-infrared light. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- total knee arthroplasty
Key exclusion criteria (6 listed)
- open injury
- pregnancy
- wound without primary closure
- infection
- previous surgery over surgical site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationPhotobiomodulation therapy will be given daily start on the first day after surgery to post operative day 6 | Device | control group, intervention group |
Primary outcome
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
3 secondary outcomes
pain score (visual analogue score)
Time frame: once daily since post operative day1 to day6
active range of motion of knee
Time frame: once daily since post operative day1 to day6
2 minute walk test
Time frame: once daily since post operative day1 to day6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 34800495de 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.
- Background: PubMed 32186975Vassao 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.
- Derived from this study: PubMed 39786308Chia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hsiang-Chieh Hsieh study chair
National Taiwan University Hospital Hsin-Chu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Inflammation and Osteoarthritis, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiang-Chieh Hsieh (886972654075, thungjay2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of bioimpedance (time frame: the bioimpedance measured once daily since post operative day1 to day6 and at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06426251, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.