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

Primary Purpose

Knee Osteoarthritis, Total Knee Replacement

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
laser acupuncture
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring laser acupuncture, low level laser therapy, total knee replacement, myofascial trigger point, auricular acupuncture

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University Beigang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser acupuncture intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes from Visual Analog Scale for myofascial trigger points
A Visual Analog Scale consists of a line, often 10 cm long, with verbal anchors at either end, on left of line, zero, meant no pain otherwise on right, 10, meant strong pain. The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.
Changes from WOMAC scale of Knee (modified in Chinese)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Knee and other osteoarthritis. This modified version is a self-administered questionnaire consisting into 4 subscales and mainly focus on functional performance: pain and ability to walk, pain and ability to go up and down stairs, knee swelling, and the range of motion of knee flexion.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2022
Last Updated
March 1, 2022
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05263856
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 7, 2022 (Anticipated)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Total Knee Replacement
Keywords
laser acupuncture, low level laser therapy, total knee replacement, myofascial trigger point, auricular acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser acupuncture intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
laser acupuncture
Other Intervention Name(s)
low level laser therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from Visual Analog Scale for myofascial trigger points
Description
A Visual Analog Scale consists of a line, often 10 cm long, with verbal anchors at either end, on left of line, zero, meant no pain otherwise on right, 10, meant strong pain. The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.
Time Frame
The 1 day Before the first laser acupuncture and the 1 day after the last laser acupuncture intervention
Title
Changes from WOMAC scale of Knee (modified in Chinese)
Description
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Knee and other osteoarthritis. This modified version is a self-administered questionnaire consisting into 4 subscales and mainly focus on functional performance: pain and ability to walk, pain and ability to go up and down stairs, knee swelling, and the range of motion of knee flexion.
Time Frame
Baseline (Before surgery), 1 month after surgery, and 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Chuan Chang, M.D.
Phone
+886-5-7837901
Ext
1229
Email
d5715@mail.bh.cmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Chuan Chang, M.D.
Organizational Affiliation
China Medical University Beigang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Beigang Hospital
City
Beigang
State/Province
Yunlin
ZIP/Postal Code
651012
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Chuan Chang, M.D.
Phone
+886-5-7837901
Ext
1229
Email
d5715@mail.bh.cmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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