Low-level Laser Acupuncture Reduces Postoperative Pain and Morphine-related Side Effects in Patients With Total Knee Arthroplasty:

NCT ID: NCT03995446

Last Updated: 2019-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-24

Study Completion Date

2019-04-21

Brief Summary

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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.

Detailed Description

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Therefore, the purpose of this study was to apply low level laser therapy Measured variables included postoperative pain intensity, patient-controlled analgesia requirements, side effects caused by morphine, knee stiffness and wound pain in the daily activities of patients undergoing total knee arthroplasty. Data were collected between April 2018 and January 2019. Eighty-two knee osteoarthritis patients receiving total knee arthroplasty were recruited from one hospital and randomly, equally assigned to the laser acupuncture or control group. The LA group received the low-level laser therapy with 3 joules at each acupuncture point at Hour 2, Hour 6, Hour 10, Hour 24, Hour 48, and Hour 72 after surgery; whereas the control group received the same manner except for joule.

Conditions

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Low-level Laser Acupuncture in Patients With Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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low-level laser therapy

808nM wavelength, power density of 300mW

Group Type EXPERIMENTAL

low-level laser

Intervention Type DEVICE

low level laser emission on specific acupuncture points

Sham laser acupuncture treatment

received the same manner except for joule.

Group Type SHAM_COMPARATOR

Sham laser

Intervention Type DEVICE

Sham laser

Interventions

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low-level laser

low level laser emission on specific acupuncture points

Intervention Type DEVICE

Sham laser

Sham laser

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Veteran General Hospital : Taipei City, Taiwan 11217, R.O.C.

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 35459599 (View on PubMed)

Other Identifiers

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2018-02-007BCF

Identifier Type: -

Identifier Source: org_study_id

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