A Pilot Trial of Acupuncture for Knee Osteoarthritis With Differential Functional Status of Acupoints

Sichuan University

Status

Completed

Conditions

Randomized Controlled Trial

Acupuncture

Knee Osteoarthritis

Treatments

Other: acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT03008668

201681590955

Details and patient eligibility

About

The investigators plan to undertake a rigorous multicentre randomised controlled trial, comparing acupuncture on sensitized acupoints with low/non-sensitive points or no acupuncture (waiting-list), to test if acupuncture on sensitized acupoints may result in improved treatment outcomes in patients with Knee osteoarthritis (KOA).The current pilot study aimed to assess the feasibility of performing the definitive randomised controlled trial.

Full description

Patients in the intervention group received acupuncture treatment on the 5 most sensitized points/ acupoints.Patients in the control group received acupuncture treatment on the 5 least /non-sensitized points. All other treatment settings were the same as in the intervention group.

Enrollment

36 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Eligible patients are those aged 40 years or older who are diagnosed with KOA and have signed the informed consent.
The diagnosis of KOA will follow the diagnostic criteria according to the Chinese Guidelines for the Medical Management of Osteoarthritis:
refractory knee pain for most days in the last month;
joint space narrowing, sclerosis or cystic change in subchondral bone (as indicated by X-ray);
laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count < 2000/mm3;
age 40 years or older;
morning stiffness continues less than 30 minutes;
bone sound exists when joints was taking flexion and/or extension. A person is confirmed to be diagnosed with KOA if meeting the either of the three criteria set: (1 and 2), or (1,3 and 5), or (1,4,5 and 6).

Exclusion criteria

Patients will be excluded if they:

Can not adhere to the study protocol in the future 6 months;
Are diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of knee/bone joint, rheumatoid arthritis;
Have sprain or other trauma;
Are unable to walk properly due to foot deformity or pain;
Are present with mental disorders;
Have comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus or blood disorder;
Females who are pregnant or lactating;
Were using physiotherapy treatments for osteoarthritis knee pain;
Had used intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months;
Received knee-replacement surgery;
Were participating or had participated in the other clinical trials.