Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

Phase 3

• Conditions: Knee Osteoarthritis
• Interventions: Device: Acupuncture treatment

• Registration Number: NCT02948218
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-16
• Study First Submitted QC: 2016-10-26
• Last Update Submitted: 2016-10-26
• Study First Posted: 2016-10-28
• Last Update Posted: 2016-10-28
• Study Start: 2017-01
• Primary Completion: 2020-01
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shanghai Guanghua hospital	Acupuncture treatment	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.
Shanghai Yueyang Integrated hospital	Acupuncture treatment	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.
Shanghai Longhua hospital	Acupuncture treatment	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.
Huadong hospital of Fudan University	Acupuncture treatment	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.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale	12 weeks	Visual analogue scale assessed for 12 weeks

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster university of orthopedic index	12weeks	Western Ontario and McMaster university of orthopedic index assessed for 12 weeks.
Lequesne index	12 weeks	Lequesne index assessed for 12 weeks.
Adverse Event	12 weeks	Adverse Event assessed for 12 weeks.
The Medical Outcomes Study short form health survey-36	12 weeks	The Medical Outcomes Study short form health survey-36 assessed for 12 weeks.

Trial Locations

Locations (1)

Longhua Hospital; 🇨🇳 Shanghai, Shanghai, China