## Protocol Section
### Identification Module
**NCT ID:** NCT06426251

**Brief Title:** Photobiomodulation Therapy in Patients Receiving Total Knee Arthroplasty

**Official Title:** A Randomized Trial of Photobiomodulation Effect in Patients Receiving Total Knee Arthroplasty

#### Organization Study ID Info
**ID:** 111-036-F
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan University Hospital Hsin-Chu Branch
### Status Module
#### Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-02
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Taiwan University Hospital Hsin-Chu Branch

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Inflammation

- Osteoarthritis

- Post Operative Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 15

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Photobiomodulation

**Label:** intervention group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Device: Photobiomodulation

**Label:** control group

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- control group

- intervention group

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

**Name:** Photobiomodulation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** bioimpedance of the surgical site will be measured for evaluation of swelling change

**Measure:** the change of bioimpedance

**Time Frame:** the bioimpedance measured once daily since post operative day1 to day6 and at 2 weeks

#### Secondary Outcomes

**Description:** patient reported pain score, from 0 to 100 points

**Measure:** pain score (visual analogue score)

**Time Frame:** once daily since post operative day1 to day6

**Description:** active range of motion of knee

**Measure:** active range of motion of knee

**Time Frame:** once daily since post operative day1 to day6

**Description:** the distance that the patient could walk within 2 minutes

**Measure:** 2 minute walk test

**Time Frame:** once daily since post operative day1 to day6

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* total knee arthroplasty

Exclusion Criteria:

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

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** thungjay2@gmail.com

**Name:** Hsiang-Chieh Hsieh

**Phone:** 886972654075

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hsinchu

**Contacts:**

***Contact 1:***

- **Email:** thungjay2@gmail.com

- **Name:** Hsiang-Chieh Hsieh

- **Phone:** +886972654075

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** National Taiwan University Hospital, Hsin-Chu Branch

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** National Taiwan University Hospital Hsin-Chu Branch

**Name:** Hsiang-Chieh Hsieh

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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:** 34800495

**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.

**PMID:** 32186975

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Post Operative Pain

- ID: M12926

- Name: Osteoarthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007249

- Term: Inflammation

- ID: D000010149

- Term: Pain, Postoperative

### Misc Info Module

- Version Holder: 2024-05-31
