The Effect of Laser Acupuncture Intervention to the Prognosis After TKR Surgery

NCT ID: NCT05263856

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2022-10-31

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.

Conditions

Knee Osteoarthritis; Total Knee Replacement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser acupuncture intervention

In this arm, subjects will receive laser acupuncture (LA) intervention during hospitalization after total knee replacement (TKR) surgery until discharge once a day. LA will stimulate on the 1) bilateral reflection areas of ear associated knee and pain mechanism, including Knee, Sympathetic Autonomic, Zero, Thalamus, Master Cerebral, Master Sensorial points, with 6 points unilaterl and 12 points in total, and 2) myofascial trigger point around knee joint, which may affect function performance and prognosis after TKR, including quadriceps, tensor fascia lata,adductor major,sartorius, hamstrings, gastrocnemius muscles, with 10 points in total.

Group Type: EXPERIMENTAL

laser acupuncture

Intervention Type: DEVICE

The parameter setting of 810nm wavelength laser acupuncture device in 1) ear were irradiated with a 4mm probe, adjusted to Nogier A frequency for acute treatment, and the pulsed mode was irradiated with an emission frequency of 200mW for 10seconds, each acupoint provided 1 joule of energy with total of 12joules,and 2) myofascial trigger point were irradiated with a 10mm probe, adjusted to Nogier C frequency for muscle treatment, and the pulsed mode was irradiated with an emission frequency of 500mW for 20 seconds, each acupoint provided 5 joule of energy with total of 50 joules, providing a total of 62 joules of one intervention session.

Interventions

laser acupuncture

The parameter setting of 810nm wavelength laser acupuncture device in 1) ear were irradiated with a 4mm probe, adjusted to Nogier A frequency for acute treatment, and the pulsed mode was irradiated with an emission frequency of 200mW for 10seconds, each acupoint provided 1 joule of energy with total of 12joules,and 2) myofascial trigger point were irradiated with a 10mm probe, adjusted to Nogier C frequency for muscle treatment, and the pulsed mode was irradiated with an emission frequency of 500mW for 20 seconds, each acupoint provided 5 joule of energy with total of 50 joules, providing a total of 62 joules of one intervention session.

Intervention Type: DEVICE

Other Intervention Names

low level laser therapy

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Chuan Chang, M.D.

Role: PRINCIPAL_INVESTIGATOR

China Medical University Beigang Hospital

Locations

China Medical University Beigang Hospital

Beigang, Yunlin, Taiwan

Countries

Taiwan

Central Contacts

Yi-Chuan Chang, M.D.

Role: CONTACT

d5715@mail.bh.cmu.edu.tw

+886-5-7837901 ext. 1229

Facility Contacts

Yi-Chuan Chang, M.D.

Role: primary

d5715@mail.bh.cmu.edu.tw

+886-5-7837901 ext. 1229

Other Identifiers

1-CMUBHR109-005

Identifier Type: OTHER

Identifier Source: secondary_id

CMUH111-REC2-026

Identifier Type: -

Identifier Source: org_study_id