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

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

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.

Study Overview

• Status: Completed
• Conditions: Low-level Laser Acupuncture in Patients With Total Knee Arthroplasty
• Intervention / Treatment: Device: low-level laser; Device: Sham laser

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veteran General Hospital : Taipei City, Taiwan 11217, R.O.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: low-level laser therapy; 808nM wavelength, power density of 300mW	Device: low-level laser; low level laser emission on specific acupuncture points
SHAM_COMPARATOR: Sham laser acupuncture treatment; received the same manner except for joule.	Device: Sham laser; Sham laser

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• Huang CH, Yeh ML, Chen FP, Wu D. Low-level laser acupuncture reduces postoperative pain and morphine consumption in older patients with total knee arthroplasty: A randomized placebo-controlled trial. J Integr Med. 2022 Jul;20(4):321-328. doi: 10.1016/j.joim.2022.04.002. Epub 2022 Apr 9.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 24, 2018
• Primary Completion (ACTUAL): January 21, 2019
• Study Completion (ACTUAL): April 21, 2019

Study Registration Dates

• First Submitted: May 19, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (ACTUAL): June 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 21, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Acupuncture points, low-level laser, postoperative pain, total knee arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2018-02-007BCF

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