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

NCT05263856 | Unknown

• 2 other identifiers: CMUH111-REC2-0261-CMUBHR109-005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Total Knee Replacement

Keywords

laser acupuncture; low level laser therapy; total knee replacement; myofascial trigger point; auricular acupuncture

Outcome Measures

Primary Outcomes (2)

• 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.

  The 1 day Before the first laser acupuncture and the 1 day after the last laser acupuncture intervention

• 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.

  Baseline (Before surgery), 1 month after surgery, and 3 months after surgery

Study Arms (1)

Laser acupuncture intervention

EXPERIMENTAL

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.

Device: laser acupuncture

Interventions

laser acupuncture 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.

Also known as: low level laser therapy

Laser acupuncture intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Beigang Hospital

Beigang, Yunlin, 651012, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Yi-Chuan Chang, M.D.

  China Medical University Beigang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Chuan Chang, M.D.

CONTACT

+886-5-7837901; d5715@mail.bh.cmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 3, 2022
• Study Start: March 7, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-03

Locations

TW (1)