Individualized acupuncture randomized trials in patients with osteoarthritisof the knee: -Design and protocols1)Kim Yong-Suk, 2)Lee Seung-Deok, 2)Seo Jung-Chul, 2)Lee Sang-Hoon, 3)Choi Sun-Mi, 2)KimSun-Woong, 4)Takahashi Norihito, 4)Sumiya Eiji, 4)Shichidou Toshiyuki, 4)Kawakita Kenji1)Kyung Hee University, Korea,

2) KAMS (Korean Acupuncture and Moxibustion Society),

Oriental Medicine, Korea,
4) JSAM (Japan Society of Acupuncture and Moxibustion)3) Korea Institute ofOver the last thirty years, a variety of clinical trials have been conducted to define theeffectiveness of acupuncture. Unfortunately, these outcomes are far from the real outcomesof practice where many patients and doctors actually experience the effectiveness ofacupuncture. Researchers evaluating acupuncture have little guidance in selecting
appropriate interventions for their studies because treatments in actual practice areindividualized to the needs of patients. Acupuncture studies should be planned ontheoretical basis of Oriental Medical systems and designed to allow divergent approaches as
in clinical practice and to compare these systems with treatment using fixed acupuncture
points.
In order to develop protocols for the individualized acupuncture, some obstacles such as
the pattern identification, selection of acupuncture points, period of time to retain needles,
number of needles practiced, elicitation of de qi, depth of insertion, types of needle
manipulation must be overcome in rigorous way. In order to make a consensus concerning
acupuncture prescription, we conducted e-mail and telephone survey questionnaires, andfollowed up with face-to-face interviews with acupuncture practitioner. Similar survey will
be conducted in Japanese acupuncturists.
We, Koran-Japan
EBM working group, will investigate whether individualizedacupuncture provides greater pain relief and more improvement of quality of life among
patients with osteoarthritis of the knee in Korea and Japan than standardized acupuncture.
This randomized clinical trial will recruit 126 participants with osteoarthritis of the knee.
This study consists of a screening visit, baseline assessment visit, a treatment period, and athree-month follow-up visit. Following screening, eligible participants will be randomized to
one of two groups: individualized and standardized acupuncture. For individualized
acupuncture, acupuncture points will be tailored to each participant. For standardized
acupuncture we will use a pre-specified set of acupuncture points. Acupuncture treatment
will be delivered twice a week for 6 weeks. Each patient will participate in this study for
maximum of 5 months. The primary outcome measure is the difference between baseline
and the end of the 6-week treatment period in the pain intensity as measured by a visual
analogue scale (VAS; 0-100 mm). The secondary outcome measures are as follows: Western
Ontario and McMaster University (WOMAC) osteoarthritis score, quality of life (QOL) andLequensne Functional Index Score. All main analyses will be made by intention to treat(ITT). Some modifications of the protocol will be made, and preliminary results of theindividualized acupuncture trials will be presented for the discussion.