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

Not Applicable

Completed

• Conditions: Low-level Laser Acupuncture in Patients With Total Knee Arthroplasty
• Interventions: Device: Sham laser; Device: low-level laser

• Registration Number: NCT03995446
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-04-24
• Primary Completion: 2019-01-21
• Study Completion: 2019-04-21
• Study First Submitted: 2019-05-19
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-21
• Last Update Submitted: 2019-06-21
• Study First Posted: 2019-06-24
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham laser acupuncture treatment	Sham laser	received the same manner except for joule.
low-level laser therapy	low-level laser	808nM wavelength, power density of 300mW

Primary Outcome Measures

Name	Time	Method
The Numerical Rating Scale (NRS)	the first 72 hours after the surgery	NRS was assessed pain intensity, ranging from 0 (no pain) to 10 (worst pain imaginable).higher scores, higher pain.
Brief Pain Inventory (BPI)	the first 72 hours after the surgery	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).

Trial Locations

Locations (1)

Taipei Veteran General Hospital : Taipei City, Taiwan 11217, R.O.C.; 🇨🇳 Taipei, Taiwan