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Completed

NCT Number: NCT03633097

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

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

Completed

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Key information

Conditions

Knee Replacement Acupuncture

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic Kwandong University International St. Mary'S Hospita, Incheon, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Acupuncture and Usual care

Other

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

Usual Care

Drug

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

Primary outcomes

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

    Time frame: Screening, day 11, day 21

    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

Secondary outcomes

  1. Change from baseline in Numeric rating scale

    Time frame: Screening, baseline, day 5, 11, 21, 28, 84

    NRS range was 0-10 with 0 being no pain and 10 the worst pain possible.

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

    Time frame: Screening, day 11, day 84

    mobility (5 meters walking test at comfortable speed - 5mWT) (meters/second)

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

    Time frame: Screening, day 11, day 84

    endurance (Sit-to-stand test - STS) (seconds)

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

    Time frame: Screening, day 11, day 84

    a functional test evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).

  5. Change from baseline in Alternative-Step Test at every visit

    Time frame: Screening, day 11, day 84

    a functional test measuring clinical balance performance, and it has been shown to predict fall risk among elderly subjects (seconds)

  6. Change from baseline in Range of motion

    Time frame: Screening, baseline, day 5, 11, 28, 84

    Compare flexion and extension angle using long arm goniometer between experimental and comparator group

Sponsors and collaborators

Lead sponsor

Gachon University Gil Oriental Medical Hospital

Other

Collaborators

  • Korea Health Industry Development Institute

Registry information

Official study title

Efficacy and Safety of Acupuncture Treatment as an Adjunctive Therapy After Knee Replacement - Single-center, Pragmatic, Randomized, Assessor Blinded, Pilot Study-

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Aug 16, 2018
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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