Efficacy of Moxibustion Treatment as Adjunctive
Therapy in Osteoarthritis (OA) of the Knee:
A Randomized Controlled Clinical Trial
Ling Zhao1 Fan Wu1 Lizhen Wang1 Haimeng Zhang1 Haiping Deng1,2
Ke Cheng1,2 Lixing Lao 1,3 Xueyong Shen1
1 Shanghai University of Traditional Chinese Medicine, Shanghai, China
2 Shanghai Research Center of Acupuncture & Meridian, Shanghai, China
3 University of Maryland, School of Medicine, Baltimore, USA
BACKGROUND
Knee OA is a common disabling problem in elderly.
Moxibustion, a part of traditional Chinese medicine
modality, is a non-invasive procedure.
Moxibustion has been practiced in China for thousands of
years.
Efficacy of moxibustion for reducing the pain and
dysfunction of osteoarthritis is not well-investigated.
Aim and Purpose
To evaluate the efficacy and safety of
the traditional moxibustion in treating
patients with knee OA.
Methods –Design
A double-blind, sham-controlled randomized
clinical trial with two arms:
1) Moxibustion + UC (N=55)
2) Sham control + UC (N=55).
Multi-sited: three TCM Hospitals in Shanghai.
The study protocol was approved by Chinese
Ethics Committee of Registering Clinical Trials
based in Chengdu, China.
Methods –Inclusion Criteria
45 years old or above;
Diagnosed as knee OA according to American College
of Rheumatology (ACR) criteria, radiographic evidence
(Kellgren–Lawrence score 2 or 3);
Pain score of moderate or greater (at least 3 points in a
10 point Visual Analogue Scale ) on most days during
the previous month;
Willingness to sign the consent form for randomization.
Methods – Exclusion Criteria
The presence of serious medical conditions;
Intra-articular corticosteroid or hyaluronate injections (as
well as any knee surgeries or concomitant use of topical
capsaicin cream) during the past 6 months;
Previous experience with moxibustion;
Any planned events that would interfere with participation in
the study during the following 24 weeks.
Methods –Device
Diagram of the moxibustion pillar.
(A) Moxa cylinder (moxa wool). Top of the base (an insulated
plate made of aluminum with an asbestos core).
(B) The real device has an opening in the center to allow the
heat and smoke from the burning moxa cylinder to
circulate at the surface of the acupuncturepoint.
(C) The sham device has a closed plate. Medial membrane
(paper) that serves as a buffer to reduce the heat
produced by the burning moxa.
(D) Adhesive-surfaced rim (the bottom of the paper plank)
with an opening in the center, used to attach the device to
the skin.
Methods – Intervention
Treatment: three times a week for 6
weeks.
Three acupoits: ST 35 (Dubi), EX-LE 4
(Neixiyan), and Ashi point.
Three pillars for each aupoints.
Total 20 minutes for one treatment.
Methods – Outcomes
Primary endpoint (WOMAC): week 6 after the last
treatment and at 3 wk, 12 wk and 24 wk.
AEs were self-reported by patients and documented by
practitioners at each treatment section.
Patient blinding was assessed at the end of the six-week
intervention.
Flowchart
Assessed for eligibility=124)
Randomly assigned (n=110)
Withdrew: 60~3weeks: 0
3~6weeks: 06~12weeks: 3
12~24weeks: 3
Withdrew: 50~3weeks: 0
3~6weeks: 06~12weeks: 2
12~24weeks: 3
Excluded (n=14)Insufficient
pre-experimental pain while walking
on a flat surface: 5 Others: 8
receive sham moxibustion (n=55)
Observation available for analysis0~3weeks: 553~6weeks: 55
6~12weeks: 5212~24weeks: 49
Observation available for analysis0~3weeks: 553~6weeks: 55
6~12weeks: 5312~24weeks: 50
receive active moxibustion (n=55)
Characteristics Active group
(n=55)
Sham group
(n=55)
Total
(n=110)
age, y 65.80±7.45 64.55±8.38 65.17±7.89
Sex, n (%)
Men 16(29.09) 21(38.18) 37(33.63)
Women 39(70.90) 34(61.81) 73(66.36)
Target knees (%)
1 knee 12(21.82) 18(32.73) 30(27.27)
2 knees 43(78.18) 37(67.27) 80(72.72)
Length of diagnosis of osteoarthritis, n (%)
< 5y 30(54.55) 37(67.27) 67(60.90)
6-10 y 18(32.73) 12(21.82) 30(27.27)
>10y 7(12.73) 6(1.090) 13(11.82)
Weight 64.06±9.02 66.01±5.21 65.04±6.33
Hight 1.63±5.28 1.62±1.45 1.62±7. 98
BMI 24.11±1.08 25.15±2.41 24.63±5.52
Outcomes(before)
WOMAC pain score 336.6±117.4 314.4±135.1 325.5±261.5
WOMAC stiffness score 45.1±25.2 53.3±76.5 49.2±56.9
WOMAC function score 569.0±261.3 526. 9±303.0 547.9±282.4
Results---Participant Demographic and
Baseline Characteristics
Results---WOMAC index scores change
between group comparison (mean ±SE) #
Endpoint week Active group(n=55)
(%)
Sham group(n=55)
(%) P value
Pain 3 24.65±5.85 2.63±5.49 0.027*
6 52.87±4.26 24.43±4.75 0.001*
12 57.90±4.28 18.37±5.92 0.0001*
24 50.75±4.72 20.47±5.44 0.002*
Stiffness 3 13.32±9.33 -38.26±23.87 0.24
6 38.28±7.11 -16.92±26.81 0.174
12 45.44±6.33 -18.16±21.90 0.039*
24 43.76±5. 78 19.66±7.68 0.088
Function 3 21.71±10.69 -7.23±9.20 0.008*
6 39.03±9.61 13.14±10.58 0.036*
12 50.84±5.89 14.51±8.51 0.002*
24 43.58±7.22 11.28±10.90 0.077
# WOMAC index score reduction change (after treatment –baseline) / baseline ×100%
* p<0.05 for comparisons between two groups
Results ---- Blinding
Kappa Consistency test (K=-0.53,P=0.833)showed
that the practitioners’ judgments about which group
they treating were successfully blinded.
Fisher's Exact Test showed that there was no difference
of patients’ judgments between the two groups on
allocation assignment (P=0.565).
Results --- Drop-out rate and AEs
Dropout (<10%):
Moxibustion: 3/22 (wk 12); 6/55 (wk 24)
Sham-control: 2/22 (wk 12); 5/55 (wk24)
AEs:
Skin flushing in moxibusion group (10).
Discussion
Traditional moxibustion seems effective as
compared the sham control.
There is no significant adverse effect of moxibustion.
The sham moxa-device is a valid placebo control
device and the blinding of both practitioners and
patients were successful..
Conclusion
Six week of moxibustion treatment seems
to effectively relieve pain and improve
function in patients with knee OA up to 18
weeks after the treatment.
Thanks for your attention!
Questions?