The investigators plan to investigate the effectiveness of acupuncture at highly sensitive points, compared with lowly/non-sensitive points or no acupuncture (waiting-list), in improving pain, joint function and quality of life, among patients with KOA. The safety of acupuncture will also be assessed during the study period.
Participants in the high sensitization group receive acupuncture treatment at the five highly sensitive points; Participants in the low/non-sensitization group receive acupuncture treatment at the five low/non-sensitive points and all other treatment settings will be the same as in the high sensitization group. Patients in the waiting-list group will receive standard acupuncture treatment after the study is completed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
666
a stimulation of the body or auricular points
the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China
Wuhan Integrated Traditional Chinese Medicine and Western Medicine Hospital
Wuhan, Hubei, China
Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University
Chengdu, Sichuan, China
the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks
It consists of 24 items assessing the knee osteoarthritis patients pain, stiffness, and physical function. Each of the 24 items will be graded on a visual analog scale ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function.
Time frame: Assessments will be conducted at baseline and 16 weeks after randomization
The change of Short Form (SF)-12 health survey score from baseline to 16 weeks
It includes 12 items: 2 items on physical functioning, 2 items on role limitations because of physical health problems, 1 item on bodily pain, 1 item on general health perceptions, 1 item on vitality (energy/fatigue), 1 item on social functioning, 2 items on role limitations because of emotional problems, and 2 items on general mental health (psychological distress and psychological well-being).
Time frame: Assessments will be conducted at baseline and 16 weeks after randomization
The changes of knee ranges of motion (ROMs) from baseline to 16 weeks
The knee ROMs will be assessed both actively and passively by using a standard goniometer. It will include flexion, extension, internal rotation and external rotation.
Time frame: Assessments will be conducted at baseline and 16 weeks after randomization
The changes of pressure-pain threshold of the five selected acupuncture points from baseline to 16 weeks
The pressure-pain threshold of the five selected acupuncture points will be measured using the electronic von Frey detector.
Time frame: Assessments will be conducted at baseline and 16 weeks after randomization
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