Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

Study Overview
=================
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.

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.

Official Title
-----------------
Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: Acupuncture treatment


Participation Criteria
=================
Eligibility 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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Shanghai Longhua hospital<br>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<br>* 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.<br>|
| Active Comparator: Shanghai Guanghua hospital<br>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<br>* 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.<br>|
| Active Comparator: Huadong hospital of Fudan University<br>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<br>* 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.<br>|
| Active Comparator: Shanghai Yueyang Integrated hospital<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | Visual analogue scale assessed for 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster university of orthopedic index | Western Ontario and McMaster university of orthopedic index assessed for 12 weeks. | 12weeks | 
| Lequesne index | Lequesne index assessed for 12 weeks. | 12 weeks | 
| Adverse Event | Adverse Event assessed for 12 weeks. | 12 weeks | 
| The Medical Outcomes Study short form health survey-36 | The Medical Outcomes Study short form health survey-36 assessed for 12 weeks. | 12 weeks |