NCT03633097

Brief Summary

Efficacy and Safety of Acupuncture Treatment as an Adjunctive Therapy After Knee Replacement

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

2.1 years

First QC Date

July 31, 2018

Last Update Submit

July 7, 2021

Conditions

Knee ReplacementAcupuncture

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Korean version of Western Ontario and McMaster Universities Arthritis Index

    K-WOMAC is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales

    Screening, day 11, day 21

Secondary Outcomes (6)

  • Change from baseline in Numeric rating scale

    Screening, baseline, day 5, 11, 21, 28, 84

  • Change from baseline in Physical Condition related with mobility at every visit

    Screening, day 11, day 84

  • Change from baseline in Physical Condition related with endurance at every visit

    Screening, day 11, day 84

  • Change from baseline in Timed Up and Go Test at every visit

    Screening, day 11, day 84

  • Change from baseline in Alternative-Step Test at every visit

    Screening, day 11, day 84

  • +1 more secondary outcomes

Study Arms (2)

Acupuncture + Usual care

EXPERIMENTAL

Acupuncture with Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet

Other: Acupuncture and Usual care

Usual care

ACTIVE COMPARATOR

Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet

Drug: Usual care

Interventions

Acupuncture and Usual careOTHER

patients after surgery receive usual care(Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet) as well as acupuncture treatment as an adjunctive therapy

Acupuncture + Usual care
Usual careDRUG

patients after surgery receive usual care alone(Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet)

Usual care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has a diagnosis of osteoarthritis and listed for an unilateral total knee replacement.
  • Subject has a normal cognitive function
  • Subject is willing and able to give informed consent for participation in the study.

You may not qualify if:

  • Those who have undergone total knee arthroplasty due to gout
  • Those who have had total knee arthroplasty due to trauma
  • Those who have had total knee arthroplasty due to autoimmune related diseases such as rheumatoid arthritis
  • Those who are participating in other clinical trials
  • Those who have a history of participating in other clinical trials within one month
  • Those who are difficult to write a research consent form
  • Those who are judged to be inappropriate for the clinical study by the researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Catholic Kwandong University International St. Mary'S Hospital

Incheon, 22711, South Korea

Location

Catholic Kwandong University International St. Mary'S Hospita

Incheon, 22761, South Korea

Location

Related Publications (1)

  • Park TY, Kim HJ, Lee JH, Sunwoo YY, Do KS, Han SN, Song YK, Chae DS. Efficacy and safety of acupuncture treatment as an adjunctive therapy after knee replacement: Single-center, pragmatic, randomized, assessor blinded, pilot study. Medicine (Baltimore). 2021 Mar 12;100(10):e24941. doi: 10.1097/MD.0000000000024941.

    PMID: 33725856DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Yun Kyung Song, PhD

    Gachon university of Gil oriental hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
single blinded, outcome assessor blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sponsor-principle investigator

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 16, 2018

Study Start

November 30, 2018

Primary Completion

December 30, 2020

Study Completion

May 30, 2021

Last Updated

July 8, 2021

Record last verified: 2021-07

Locations

KR(2)