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Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis

Primary Purpose

Knee Arthritis Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
physiotherapy
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthritis Osteoarthritis focused on measuring Osteoarthritis, MRI, Cartilage, Acupuncture

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically diagnosed as knee osteoarthritis according to the OA criteria proposed by American College of Rheumatology in 1995.

Exclusion Criteria:

  • Acute knee injury
  • Had ever accepted therapy as hormone or injection in articulation cavity
  • Had ever accepted treatment as oral medicine, physiotherapy, acupuncture or massage during the passed three months
  • Had planted cardiac pacemaker or any metal matter in body
  • Other severe diseases such as heart, lung, liver, kidney or cerebrum failure, tumors, gastrointestinal hemorrhage and so on
  • Pregnant or lactating woman
  • Anyone unable to tolerate or cooperate with treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    acupuncture group

    physiotherapy group

    Arm Description

    Acupuncture treatment was given once every other day and 20min each time for four weeks.

    Physiotherapy treatment was given five times a week and 30min each time for four weeks.

    Outcomes

    Primary Outcome Measures

    WOMAC scores
    T2 Values

    Secondary Outcome Measures

    Full Information

    First Posted
    May 6, 2015
    Last Updated
    May 13, 2015
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02446756
    Brief Title
    Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis
    Official Title
    Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    February 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To observe the therapeutic effect of acupuncture on osteoarthritis(OA) and its efficacy on cartilage restoration,acupuncture and physiotherapy treatment were respectively given to two random groups. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.
    Detailed Description
    To observe the therapeutic effect of acupuncture on osteoarthritis and its efficacy on cartilage restoration,one hundred knees of 50 patients with knee osteoarthritis were randomly divided into acupuncture group and physiotherapy group which were respectively received acupuncture and physiotherapy treatment for four weeks. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Arthritis Osteoarthritis
    Keywords
    Osteoarthritis, MRI, Cartilage, Acupuncture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    acupuncture group
    Arm Type
    Experimental
    Arm Description
    Acupuncture treatment was given once every other day and 20min each time for four weeks.
    Arm Title
    physiotherapy group
    Arm Type
    Active Comparator
    Arm Description
    Physiotherapy treatment was given five times a week and 30min each time for four weeks.
    Intervention Type
    Other
    Intervention Name(s)
    acupuncture
    Intervention Type
    Other
    Intervention Name(s)
    physiotherapy
    Primary Outcome Measure Information:
    Title
    WOMAC scores
    Time Frame
    up to 24 months
    Title
    T2 Values
    Time Frame
    up to 30 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinically diagnosed as knee osteoarthritis according to the OA criteria proposed by American College of Rheumatology in 1995. Exclusion Criteria: Acute knee injury Had ever accepted therapy as hormone or injection in articulation cavity Had ever accepted treatment as oral medicine, physiotherapy, acupuncture or massage during the passed three months Had planted cardiac pacemaker or any metal matter in body Other severe diseases such as heart, lung, liver, kidney or cerebrum failure, tumors, gastrointestinal hemorrhage and so on Pregnant or lactating woman Anyone unable to tolerate or cooperate with treatment.

    12. IPD Sharing Statement

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