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

Low-level Laser Acupuncture in Patients With Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995446
• Other study ID #: 2018-02-007BCF
• Status: Completed
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: April 21, 2019

Study information

• Verified date: June 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 21, 2019
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Low-level Laser Acupuncture in Patients With Total Knee Arthroplasty
• Pain, Postoperative

Intervention

Device:
• low-level laser
low level laser emission on specific acupuncture points
• Sham laser
Sham laser

Locations

Country	Name	City	State
Taiwan	Taipei Veteran General Hospital : Taipei City, Taiwan 11217, R.O.C.	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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