Low-level Laser Acupuncture Reduces Postoperative Pain and Morphine-related Side Effects in Patients With Total Knee Arthroplasty:
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2019
CompletedFirst Submitted
Initial submission to the registry
May 19, 2019
CompletedFirst Posted
Study publicly available on registry
June 24, 2019
CompletedJune 24, 2019
June 1, 2019
9 months
May 19, 2019
June 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
low-level laser therapy
EXPERIMENTAL808nM wavelength, power density of 300mW
Sham laser acupuncture treatment
SHAM COMPARATORreceived the same manner except for joule.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Veteran General Hospital : Taipei City, Taiwan 11217, R.O.C.
Taipei, 11217, Taiwan
Related Publications (1)
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.
PMID: 35459599DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2019
First Posted
June 24, 2019
Study Start
April 24, 2018
Primary Completion
January 21, 2019
Study Completion
April 21, 2019
Last Updated
June 24, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share