An interventional study of acupuncture in Acupuncture, Knee Osteoarthritis and Randomized Controlled Trial, sponsored by West China Hospital. Completed. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-07-19.
Sponsored by West China Hospital · Not applicable, Interventional, and Treatment
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 36 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.
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Exclusion Criteria:
Patients will be excluded if they:
acupuncture on 5 most sensitized points/ acupoints
Other: acupuncture
acupuncture on 5 least low/non-sensitized points
Other: acupuncture
a stimulation of the body or auricular points
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
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Expected adverse events (AEs) of the acupuncture interventions include bleeding, nausea/vomiting, fainting, bruising at needle sites, feeling hot/burning, and transient pain at needle sites. We defined serious adverse events (SAEs) as: death, hospitalization, significant disability or incapacity, any life-threatening situations or any other medically significant events that were potentially related to the trial procedures or acupuncture treatments. The AEs or SAEs were identified by the certified treating acupuncturists.
Time frame: Assessments will be conducted at 4 weeks after the acupuncture treatment and followed at 8, 12 and 16 weeks
No study locations are listed for this record.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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West China Hospital