Low-level Laser Acupuncture Reduces Postoperative Pain and Morphine-related Side Effects in Patients With Total Knee Arthroplasty:

Study Overview
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Brief Summary
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Total knee arthroplasty is a common and effective surgical procedure for patients with end-stage knee osteoarthritis, and wound pain is still a problem for many of the patients.

Detailed Description
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Therefore, the purpose of this study was to apply low level laser therapy Measured variables included postoperative pain intensity, patient-controlled analgesia requirements, side effects caused by morphine, knee stiffness and wound pain in the daily activities of patients undergoing total knee arthroplasty. Data were collected between April 2018 and January 2019. Eighty-two knee osteoarthritis patients receiving total knee arthroplasty were recruited from one hospital and randomly, equally assigned to the laser acupuncture or control group. The LA group received the low-level laser therapy with 3 joules at each acupuncture point at Hour 2, Hour 6, Hour 10, Hour 24, Hour 48, and Hour 72 after surgery; whereas the control group received the same manner except for joule.

Official Title
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Low-level Laser Acupuncture Reduces Postoperative Pain and Morphine-related Side Effects in Patients With Total Knee Arthroplasty: A Randomized Controlled Trial

Conditions
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Low-level Laser Acupuncture in Patients With Total Knee Arthroplasty

Intervention / Treatment
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* Device: low-level laser
* Device: Sham laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 60 years or older American Sociological Association (ASA) class I-III spinal anesthesia, consent to patient-controlled analgesia (PCA) and peripheral nerve block (PNB) return to the ward directly from the anesthesia recovery room. Exclusion Criteria: cutaneous lesions at the application sites use of taking immunosuppressive agents received intra-articular steroid treatment opiate dependence sensitive to light epilepsy clinically significant cardiovascular diseases cancer systemic lupus erythematosus.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-level laser therapy<br>808nM wavelength, power density of 300mW | Device: low-level laser<br>* low level laser emission on specific acupuncture points<br>|
| Sham Comparator: Sham laser acupuncture treatment<br>received the same manner except for joule. | Device: Sham laser<br>* Sham laser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Numerical Rating Scale (NRS) | NRS was assessed pain intensity, ranging from 0 (no pain) to 10 (worst pain imaginable).higher scores, higher pain. | the first 72 hours after the surgery | 
| Brief Pain Inventory (BPI) | The patients answered or pointed their pain on 0-to-10 scales (0=no pain, 10=extreme pain) at the time of responding to the BPI(current pain), and also at the items of the most severe pain, the least pain, and the average pain in the last 24 hours. Using the BPI, patients were also asked to rate pain-related interference in daily activities, including general activity, mood, walking ability, normal work, relations with other people, sleeping, and enjoyment of life. The anchor points, in each items of interference scale, were 11-point NRSs (0=no interference, 10=interferes completely). | the first 72 hours after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture points, low-level laser, postoperative pain, total knee arthroplasty