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?