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Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02948218
Recruitment Status : Not yet recruiting
First Posted : October 28, 2016
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

Brief Summary:
Knee osteoarthritis (KOA) is a major public health problem among the elderly and is associated with considerable disability. A recent analysis of data indicated that about 35% of women and men aged 60 years and above had radiographic knee OA.Despite the high prevalence rate of OA, the treatment of OA is far from satisfactory. Acupuncture may be a promising treatment option for knee OA due to the effectiveness of the pain relief and the rarity of adverse effects. In order to get some more reliable data to confirm acupuncture effectiveness on KOA, a long-term follow up interventional study will be started to confirm the effects of long term for acupuncture treatment.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Acupuncture treatment Phase 3

Detailed Description:
Knee osteoarthritis (KOA) is a major public health problem among the elderly and is associated with considerable disability. A recent analysis of data from the National Health and Nutrition Examination Survey III indicated that about 35% of women and men aged 60 years and above had radiographic knee OA. Although the cause of OA can be many factors, such as previous injury, abnormal limb development and so on, its main symptom is a complex chronic pain condition. Previous studies have demonstrated central sensitization in OA patients. Despite the high prevalence rate of OA, the treatment of OA is far from satisfactory. Acupuncture could be a promising treatment option for knee OA due to the effectiveness of the pain relief and the rarity of adverse effects. In order to get some more reliable data to confirm acupuncture effectiveness on KOA, a long-term follow up interventional study with clear design, standard criteria, control group, will be started to confirm the effects of long term for acupuncture treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Shanghai Longhua hospital
Acupuncture treatments will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
Device: Acupuncture treatment
Acupuncture treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.

Active Comparator: Shanghai Guanghua hospital
Acupuncture treatments will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
Device: Acupuncture treatment
Acupuncture treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.

Active Comparator: Huadong hospital of Fudan University
Acupuncture treatments will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
Device: Acupuncture treatment
Acupuncture treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.

Active Comparator: Shanghai Yueyang Integrated hospital
Acupuncture treatments will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
Device: Acupuncture treatment
Acupuncture treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.




Primary Outcome Measures :
  1. Visual analogue scale [ Time Frame: 12 weeks ]
    Visual analogue scale assessed for 12 weeks


Secondary Outcome Measures :
  1. Western Ontario and McMaster university of orthopedic index [ Time Frame: 12weeks ]
    Western Ontario and McMaster university of orthopedic index assessed for 12 weeks.

  2. Lequesne index [ Time Frame: 12 weeks ]
    Lequesne index assessed for 12 weeks.

  3. Adverse Event [ Time Frame: 12 weeks ]
    Adverse Event assessed for 12 weeks.

  4. The Medical Outcomes Study short form health survey-36 [ Time Frame: 12 weeks ]
    The Medical Outcomes Study short form health survey-36 assessed for 12 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients who have knee OA diagnosed according to the American College of Rheumatology classification criteria (with at least one osteophyte in the tibiofemoral joint and with a Kellgren-Lawrence grade of more than 2).
  • Male and female patients who have had a history of moderate or greater knee pain of more than 3 months' duration and have reported moderate or greater, clinically significant, knee pain during most days of the last month before the interview.
  • Male and female patients who have given their consent to participate in the study.
  • Patients will be selected among those who are not on the waiting list for total knee arthroplasty by the traumatology unit of our hospital.

Exclusion Criteria:

  • Patients with any of the following will be excluded from the study: a history of any secondary OA associated with any systemic arthropathy (i.e., rheumatoid arthritis or gouty arthritis);
  • Any knee treatment with steroids, methotrexate, or azathioprine; recent traumatisms caused by acupunctured insertion;
  • A history of bleeding disorders or any disease related to acupuncture contraindications;
  • A history of any knee injection in the previous 6 months (e.g., cortisone and hyaluronic acid); a history of morphine or morphine derivative use.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948218


Contacts
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Contact: Yongjun Wang, Ph.D, M.D 8618917763018 yjwang8888@126.com
Contact: Hao Xu, Ph.D, M.D 8613788951086 hoxu@163.com

Locations
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China, Shanghai
Longhua Hospital Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Yongjun Wang, Ph.D,M.D    18917763018    yjwang8888@126.com   
Contact: Hao Xu, Ph.D,M.D    13788951086    hoxu@163.com   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
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Study Director: Yongjun Wang, Ph.D, M.D Shanghai Longhua Hospital

Publications of Results:

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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02948218     History of Changes
Other Study ID Numbers: MCRATKO
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: individual participant data (IPD) available

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases