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Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02948218
Enrollment
400
Registered
2016-10-28
Start date
2017-01-31
Completion date
2020-07-31
Last updated
2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

DEVICEAcupuncture 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.

Sponsors

Shanghai University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue scale12 weeksVisual analogue scale assessed for 12 weeks

Secondary

MeasureTime frameDescription
Western Ontario and McMaster university of orthopedic index12weeksWestern Ontario and McMaster university of orthopedic index assessed for 12 weeks.
Lequesne index12 weeksLequesne index assessed for 12 weeks.
Adverse Event12 weeksAdverse Event assessed for 12 weeks.
The Medical Outcomes Study short form health survey-3612 weeksThe Medical Outcomes Study short form health survey-36 assessed for 12 weeks.

Countries

China

Contacts

Primary ContactYongjun Wang, Ph.D, M.D
yjwang8888@126.com8618917763018
Backup ContactHao Xu, Ph.D, M.D
hoxu@163.com8613788951086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026