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

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Completed
CT.gov ID
NCT03995446
Collaborator
(none)
82
1
2
11.9
6.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: low-level laser
  • Device: Sham laser
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Low-level Laser Acupuncture Reduces Postoperative Pain and Morphine-related Side Effects in Patients With Total Knee Arthroplasty: A Randomized Controlled Trial
Actual Study Start Date :
Apr 24, 2018
Actual Primary Completion Date :
Jan 21, 2019
Actual Study Completion Date :
Apr 21, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: low-level laser therapy

808nM wavelength, power density of 300mW

Device: low-level laser
low level laser emission on specific acupuncture points

Sham Comparator: Sham laser acupuncture treatment

received the same manner except for joule.

Device: Sham laser
Sham laser

Outcome Measures

Primary Outcome Measures

  1. The Numerical Rating Scale (NRS) [the first 72 hours after the surgery]

    NRS was assessed pain intensity, ranging from 0 (no pain) to 10 (worst pain imaginable).higher scores, higher pain.

  2. Brief Pain Inventory (BPI) [the first 72 hours after the surgery]

    The patients answered or pointed their pain on 0-to-10 scales (0=no pain, 10=extreme pain) at the time of responding to the BPI(current pain), and also at the items of "the most severe pain", "the least pain", and "the average pain" in the last 24 hours. Using the BPI, patients were also asked to rate pain-related interference in daily activities, including general activity, mood, walking ability, normal work, relations with other people, sleeping, and enjoyment of life. The anchor points, in each items of interference scale, were 11-point NRSs (0=no interference, 10=interferes completely).

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Veteran General Hospital : Taipei City, Taiwan 11217, R.O.C. Taipei Taiwan 11217

Sponsors and Collaborators

  • Taipei Veterans General Hospital, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT03995446
Other Study ID Numbers:
  • 2018-02-007BCF
First Posted:
Jun 24, 2019
Last Update Posted:
Jun 24, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Taipei Veterans General Hospital, Taiwan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 24, 2019