Clinical trial NCT05263856: The Effect of Laser Acupuncture Intervention to the Prognosis After TKR Surgery
Official title: The Effect of Laser Acupuncture Intervention to the Prognosis After Total Knee Replacement (TKR) Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Total Knee Replacement
Keywords: laser acupuncture
low level laser therapy
total knee replacement
myofascial trigger point
auricular acupuncture
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study protocol is mainly focus on the patients, who suffer pain, swelling, or range of motion limitation after total knee replacement (TKR) surgery procedure,would be relieved by use non-invasive laser acupuncture to stimuli on 1) the reflection areas of ear acupuncture point associated knee and pain mechanism; 2) muscle trigger points around knee joint with adequate frequency and energy power to stimuli.

Detailed description: Traditional Chinese acupuncture has a history of several thousand years. The World Health Organization has published guidelines describing the efficacy of acupuncture in the cure or relief of 64 different symptoms and conditions as one of the most representative intangible cultural heritage of humanity. However, for the need of patients and the gradual progress of technology, the applications of laser acupuncture become widespread. Laser acupuncture (LA) is not only applicated to stimuli specific areas in need, but also one of non-invasive intervention technic with hurtless intervention, no hematoma, bleeding or swelling unpleasant feeling after intervention, which could be more accepted by children, weakness people, and patients who afraid of acupuncture. To the area that traditional Chinese acupuncture could not stimuli easily of some area reflect to brain precisely, laser acupuncture is comparably convenient to supply adaptive energy input.

The goals of this study protocol is focus on the patients who accept total knee replacement (TKR), who usually suffer pain, swelling, or range of motion limitation after TKR surgery procedure, and the investigators want to use non-invasive LA to stimuli on 1) the reflection areas of ear acupuncture point associated knee and pain mechanism; 2) myofascial trigger points around knee joint, which may affect functional performance and prognosis after TKR procedure, with adequate frequency and energy power to stimuli, to observe the efficacy of LA on pain relief, swelling decline, and range of motion in knee joint improvement. One the one side, the investigators want to shorten the period of recovery, accelerate the function performance, and enhance the quality of life of patients after TKR procedure by LA intervention,on the other side, the investigators also want to confirm the value and curative effect of LA on clinical application and to evoke new idea for further development to traditional Chinese acupuncture.

Eligibility criteria: Inclusion Criteria:

* Inpatients who completed total knee replacement (TKR) during hospitalization
* Understands and obeys conventional treatment instructions
* Subjects who are willing to receive laser acupuncture treatment

Exclusion Criteria:

* There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant and lactated women.
* There has been a history of drug abuse (including excess alcohol) that affects pain assessment.
* Infection, ulcer or injury on the local skin surface at the intervention site
* Aphasia, inability to answer questions
* Cognitive impairment, unable to cooperate with the experiment

Primary outcomes:
measure: Changes from Visual Analog Scale for myofascial trigger points
timeFrame: The 1 day Before the first laser acupuncture and the 1 day after the last laser acupuncture intervention
measure: Changes from WOMAC scale of Knee (modified in Chinese)
timeFrame: Baseline (Before surgery), 1 month after surgery, and 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beigang
country: Taiwan
facility: China Medical University Beigang Hospital
state: Yunlin
Study officials:
affiliation: China Medical University Beigang Hospital
name: Yi-Chuan Chang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: