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C OPYRIGHT Ó 2016 BY T HE J OURNAL OF B ONE AND J OINT S URGERY, I NCORPORATED

The Effects of Acupuncture on Chronic Knee Pain

Due to Osteoarthritis
A Meta-Analysis
Xianfeng Lin, MD*, Kangmao Huang, MD*, Guiqi Zhu, MD*, Zhaobo Huang, MD, An Qin, MD, PhD, and Shunwu Fan, MD

Investigation performed at the Department of Orthopaedic Surgery, Sir Run Run Shaw Hospital, Medical College of Zhejiang University,
Hangzhou, People’s Republic of China

Background: Acupuncture reportedly relieves chronic knee pain and improves physical function in patients diagnosed
with osteoarthritis, but the duration of these effects is controversial. The aim of this study was to evaluate the temporal
effects of acupuncture on chronic knee pain due to knee osteoarthritis by means of a meta-analysis.
Methods: The PubMed, Embase, and Cochrane Central Register of Controlled Trials databases were searched for
studies published through March 2015. Ten randomized controlled trials of acupuncture compared with sham acu-
puncture, usual care, or no intervention for chronic knee pain in patients with clinically diagnosed or radiographically
confirmed knee osteoarthritis were included. All of the studies were available in English. Weighted mean differences
(WMDs), 95% confidence intervals (CIs), publication bias, and heterogeneity were calculated.
Results: The acupuncture groups showed superior pain improvement (p < 0.001; WMD = 21.24 [95% CI, 21.92 to 20.56];
I2 > 50%) and physical function (p < 0.001; WMD = 4.61 [95% CI, 2.24 to 6.97]; I2 > 50%) in the short term (up to 13 weeks).
The acupuncture groups showed superior physical function (p = 0.016; WMD = 2.73 [95% CI, 0.51 to 4.94]; I2 > 50%) but
not superior pain improvement (p = 0.199; WMD = 20.55 [95% CI, 21.39 to 0.29]; I2 > 50%) in the long term (up to
26 weeks). Subgroup analysis revealed that the acupuncture groups tended to have better outcomes compared with
the controls. Significant publication bias was not detected (p > 0.05), but the heterogeneity of the studies was
substantial.
Conclusions: This meta-analysis demonstrates that acupuncture can improve short and long-term physical function, but
it appears to provide only short-term pain relief in patients with chronic knee pain due to osteoarthritis.
Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Peer review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed
by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication.
Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.

C
hronic knee pain is common among people >50 years
of age, and it can restrict daily activities such as walk-
ing, running, and stair climbing1-3. The United States is
estimated to have >20 million affected individuals4. Osteoar-
thritis is the major cause of knee pain, stiffness, and physical
disability 5. The main therapeutic goals in the treatment of os-
teoarthritis are pain relief and functional improvement1.
Both pharmacological and nonpharmacological thera-
pies are important in the management of chronic knee pain6.
Pharmacological treatments such as NSAIDs (nonsteroidal
*Xianfeng Lin, MD, Kangmao Huang, MD, and Guiqi Zhu, MD, contributed equally to the writing of this article.
anti-inflammatory drugs) and COX (cyclooxygenase)-2 in-
hibitors can have side effects, such as peptic ulcers and cardio-
vascular disease, respectively7,8. Exercise, weight loss, herbal or
nutritional supplements, and acupuncture have been recom-
mended as nonpharmacological alternatives9-11. Because many
patients with osteoarthritis have trouble exercising and losing
weight, acupuncture may be a practical option in the treatment
of chronic knee pain5,12.
Although not fully understood, the theoretical biochem-
ical basis of acupuncture is considered to include the release of

Disclosure: No external sources of funding were used for this study. The Disclosure of Potential Conflicts of Interest forms are provided with the online
version of the article.

J Bone Joint Surg Am. 2016;98:1578-85 d http://dx.doi.org/10.2106/JBJS.15.00620

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Fig. 1
Flowchart of study selection. RCT = randomized controlled trial.
various endogenous substances such as enkephalin, dynorphin,
gamma-aminobutyric acid, and b-endorphins, in the spinal
cord, midbrain, hypothalamus, and pituitary gland13-15. For each
individual patient, the knowledge of traditional Chinese medi-
cine is used to define the proper number of needles, point
selection, and acupuncture time (duration and frequency) to
achieve the optimal therapeutic effects13,14. Furthermore, the
waveform and current frequency of electro-acupuncture can be
adjusted during the acupuncture process15,16. A subjective sen-
sation during the acupuncture process, called de qi, is typically
characterized by distension, soreness, heaviness, numbness,
and/or pressure, and is considered to be a positive effect sug-
gesting the success of acupuncture13,14.
Many researchers have examined the effectiveness and
safety of acupuncture for symptoms such as back and neuro-
pathic pain17-20. Whether acupuncture has a definite therapeutic
effect on chronic knee pain is controversial. Because of the small
number of published studies and their heterogeneity, many
systematic reviews have reported inconsistent results1,5,10,21-23.
Moreover, the proposed clinical guidelines on the management
of knee osteoarthritis have contradictory views regarding acu-
puncture24-27. Nevertheless, several high-quality randomized
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controlled trials (RCTs) have recently been published2,4,12,28. The
aim of this study was to conduct an updated meta-analysis on
the duration of pain relief and function improvement obtained
by acupuncture for chronic knee pain due to osteoarthritis.
Materials and Methods
Search Strategy
A systematic review was performed in accordance with the PRISMA (Pre-
ferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline
29
(see Appendix) . We searched the PubMed, Embase, and Cochrane Central
Register of Controlled Trials databases through March 2015 using the following
terms: (1) “electro-acupuncture,” “percutaneous electrical nerve,” “acupuncture,”
or “percutaneous neuromodulation”; combined with (2) “knee,” “gonarthritis,”
“osteoarthritis,” “arthritis,” or “pain.” Only studies published in English with the
full text available were included. When several publications reported findings for
the same patients, the most recent or most complete study was chosen. Chinese
30
studies were not included .
Inclusion Criteria
Eligible articles were identified according to the flowchart in Figure 1. Studies
were included on the basis of the following criteria: (1) adult patients who had
had knee pain on most days for >3 months and had clinically diagnosed or
radiographically confirmed knee osteoarthritis; (2) treatment by body acu-
puncture or periosteal stimulation; (3) treatment of a control group with sham
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TABLE I Characteristics of the Included RCTs*

Acupuncture Group Control Group

Mean Measurement
Age Men Duration Patients Patients Time
Study Location (yr) (%) Style Sessions (wk) Enrolled Type Enrolled Points (wk)

Takeda, 199436 Canada 62 50 Formula AT 9 3 20 Sham acup. 20 3, 7

Berman, 199937 U.S. 65 40 Formula EA 16 8 36 Usual care 37 4, 8, 12
Berman, 200431 U.S. 65.5 36 Formula EA 23 26 190 Sham acup., 191, 189 4, 8, 14, 26
no acup.
Tukmachi, 200438 U.K. 62 17 Formula AT 10 5 10 Usual care 10 5
Vas, 200439 Spain 67 16 Formula EA 12 12 48 Sham acup. 49 13
Scharf, 200633 Germany 63 31 Formula AT 10 6 330 Sham acup. 367 13, 26
Weiner, 20074 U.S. 71 46 PST 6 6 44 Control PST 44 6, 12
(sham)
Jubb, 200812 U.K. 65 19 Formula AT 10 5 34 Sham acup. 34 5, 9
and EA
Chen, 201328 U.S. 60 48 Formula AT 12 £12 104 Sham acup. 109 12, 26
Hinman, 20142 Australia 64 51 Formula AT 8-12 12 70 No acup. 71 12, 24

*RCT = randomized controlled trial, AT = acupuncture treatment, EA = electric stimulation acupuncture, acup. = acupuncture, and PST = periosteal stimulation therapy.

acupuncture, usual care, or no intervention; and (4) outcomes of pain and vention” represented either no routine treatments or alternatives such as
31
physical function as measured with any instrument. education .

Definitions Data Extraction

For the meta-analysis, the acupuncture group comprised patients who received
body acupuncture or periosteal stimulation, and the control group included
those who received sham acupuncture, usual care, or no intervention. “Sham
5
acupuncture” represented nonpenetrating and placebo acupuncture . “Usual
care” represented standard, conservative pharmacological therapy. “No inter-
Two of the authors (X.L. and K.H.) reviewed all titles and abstracts indepen-
dently to determine eligibility and retrieve articles. Disagreement was resolved
by discussion between the 2 authors. If they could not reach an agreement,
another author (S.F.) was consulted and a decision was made by a majority vote.
The authors are proficient at acupuncture treatment for chronic knee pain.

TABLE II Internal Validity of the Included RCTs*

Study A B C D E F G H I J K Total
36
Takeda, 1994 1 1 0 0.5 0 0.5 NA NA 1 1 0 5
37
Berman, 1999 1 1 1 0 0 0 1 1 1 1 1 8
31
Berman, 2004 1 1 1 0.5 0 0.5 1 1 1 1 1 9
1 1 1 0 0 0 1 0 0 1 1 6†
38
Tukmachi, 2004 1 1 NA 0 0 0 NA NA 1 1 0 4
39
Vas, 2004 1 1 1 0.5 0 0.5 1 1 1 1 1 9
33
Scharf, 2006 1 1 1 1 0 1 0 1 1 1 1 9
1 1 1 0 0 0 0 1 1 1 1 7†
4
Weiner, 2007 1 1 1 1 0 1 1 1 1 1 1 10
12
Jubb, 2008 1 1 1 1 0 0 1 1 1 1 0 8
28
Chen, 2013 1 1 1 1 0 1 1 1 1 1 1 10
2
Hinman, 2014 1 1 0.5 0.5 0 1 1 1 1 1 1 9

*RCT = randomized controlled trial, and NA = not clear. The internal validity of the included RCTs was assessed by 11 Cochrane Back Review Group
criteria: (A) the method of randomization was adequate; (B) the treatment allocation was concealed; (C) the groups were similar in the most important
prognostic indicators at baseline; (D) the patients were blinded to the intervention; (E) the caregivers were blinded to the intervention; (F) the outcome
assessors were blinded to the intervention; (G) co-interventions were controlled; (H) compliance was acceptable in all groups; (I) the dropout rate was
described and acceptable; (J) the timing of assessment in all groups was the same; and (K) intention-to-treat analysis was performed. A score of ‡6
indicates a high-quality study. †Control group.
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Fig. 2
Comparisons of acupuncture and all controls on the basis of short-term WOMAC pain scores. SD = standard deviation, df = degrees of freedom, and
IV = inverse variance. In this and subsequent figures, numbers in parentheses and in square brackets represent analysis groups within the same article
and the reference number, respectively.

The following information was extracted according to a fixed protocol:
study design, geographical location, demographic information (age and sex),
numbers of acupuncture and control participants, interventions, measurement
time point(s), and outcomes (Table I). The WOMAC (Western Ontario and
McMaster Universities Osteoarthritis Index) subscales for pain and physical
function were utilized in this study because the WOMAC has been extensively
32
used to assess chronic knee pain . The duration of the effects of acupuncture
was defined by the short-term end point of up to 13 weeks and the long-term
5 33
end point of up to 26 weeks . The usual care group of 1 study (Scharf et al. )
was not included as the patients received inconsistent therapy sessions.
Validity Assessment
The Cochrane Collaboration’s tool (Table II) was used to assess bias in each
34
eligible study . It uses the following assessment criteria to indicate lack of bias:
(1) the method of randomization was adequate; (2) the treatment allocation
was concealed; (3) the groups were similar in the most important prognostic
indicators at baseline; (4) the patients were blinded to the intervention; (5) the
caregivers were blinded to the intervention; (6) the outcome assessors were
blinded to the intervention; (7) co-interventions were controlled; (8) compli-
ance was acceptable in all groups; (9) the dropout rate was described and
acceptable; (10) the timing of assessment in all groups was the same; and (11)
intention-to-treat analysis was performed. A score of 1 was awarded for each
item if the criterion was completely met; a score of 0.5, 0, or NA was recorded
for the item if the criterion was partially met, if it was not met, or if it was
unclear whether it was met, respectively. The total score for each study was then
5
calculated; a score of ‡6 indicated a high-quality study .
Statistical Analysis
Weighted mean differences (WMDs) and corresponding 95% confidence inter-
vals (CIs) were estimated by random-effect meta-analysis. The significance of the
pooled WMDs was evaluated by a Z test, and a p value of <0.05 was considered
significant. In light of possible sources of heterogeneity, the studies were stratified
by interventions, measurement time points, and outcomes, and the analysis was
repeated separately for each type of control group. The I2 statistic was used to
evaluate heterogeneity, and a fixed or random-effect model was used on the basis
of the I2 value. A p value of <0.05 was considered significant for heterogeneity.
Two sensitivity analyses were performed to assess the stability of the
pooled effects by omitting 1 of 2 individual studies to determine their influence

Fig. 3
Comparisons of acupuncture and all controls on the basis of short-term WOMAC physical function scores. SD = standard deviation, df = degrees of freedom,
and IV = inverse variance.
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Fig. 4
Comparisons of acupuncture and all controls on the basis of long-term WOMAC pain scores. SD = standard deviation, df = degrees of freedom, and
IV = inverse variance.

significantly superior short-term pain (p < 0.001; WMD = 1.24

28
on the pooled WMDs. One study was omitted because of its inadequate
12
acupuncture treatment, and the other was omitted because of its large CI.
The corresponding remaining studies (the group with adequate acupuncture
treatment or the group with relatively small CIs) were then used to recalculate
the pooled WMDs. The acupuncture treatment was accepted as adequate if it
consisted of at least 6 overall sessions, at least 1 session per week, at least 4
points needled for each painful knee over at least 20 minutes, and manual or
electrical stimulation of sufficient intensity to produce more than minimal
1
needle sensation (de qi) . Begg funnel plots were created to estimate publication
bias. The significance of the intercept was evaluated by the Egger test (with
p < 0.05 considered significant). RevMan 5.0 (Cochrane Collaboration) and
Stata 12.0 (StataCorp) statistical software packages were used for the analyses.
All p values were two-sided.
Results
Characteristics of the Studies
T en RCTs that assessed 2007 subjects were included in the
meta-analysis. The sample size ranged from 20 to 697 sub-
jects (Table I). One study included 2 control groups. All of the
studies were published in or after 1994. Their validity scores are
shown in Table II.
Meta-Analysis Findings
The acupuncture group had significantly better overall pain
(p < 0.001; WMD = 0.95 [95% CI, 0.50 to 1.41]; I2 >50%) and
physical function (p < 0.001; WMD = 3.68 [95% CI, 2.18 to
5.18]; I2 >50%) scores than the control group. It also showed
[95% CI, 0.56 to 1.92]; I2 >50%) (Fig. 2) and physical function
(p < 0.001; WMD = 4.61 [95% CI, 2.24 to 6.97]; I2 >50%)
scores (Fig. 3). Although the acupuncture group did not have
superior long-term pain scores (p = 0.199; WMD = 0.55 [95%
CI, 0.29 to 1.39]; I2 >50%) (Fig. 4), significantly better long-
term physical function scores (p = 0.016; WMD = 2.73 [95%
CI, 0.51 to 4.94]; I2 >50%) were noted (Fig. 5). The sensitivity
analyses revealed stable results (Table III); excluding either of
the 2 previously mentioned studies12,28 did not alter the pooled
WMDs. The heterogeneity of the above results was evident
from the I2 values of >50%.
The subgroup analysis suggested that the acupuncture
group had superior short and long-term pain scores compared
with the sham acupuncture and usual care groups. The acu-
puncture group also showed a trend toward better physical
function scores when compared with the various control groups
in both the short and the long term. When compared with usual
care and no acupuncture, the analysis had insufficient studies to
detect a significant change in both physical function and pain
(see Appendix).
Publication Bias
The funnel plots did not reveal obvious asymmetry of pain and
physical function scores in either the short or the long term

Fig. 5
Comparisons of acupuncture and all controls on the basis of long-term WOMAC physical function scores. SD = standard deviation, df = degrees of freedom,
and IV = inverse variance.

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TABLE III Sensitivity Analyses (Omitting a Single RCT)*
All studies
Selected study omitted
12
Jubb, 2008
28
Chen, 2013
*RCT = randomized controlled trial, and WMD = weighted mean difference.
(see Appendix). Consistently, the Egger test suggested a lack of
publication bias for both pain (p = 0.88) and physical function
(p = 0.69) scores (see Appendix). The funnel plots of the time
subgroups are also depicted in the Appendix. According to this
analysis, the included studies were relatively comprehensive
and yielded statistically reliable results.
Discussion
T his meta-analysis demonstrates that acupuncture can re-
sult in both short and long-term improvement in function
in patients with chronic knee pain due to osteoarthritis, but
that the effect of pain relief is not sustained in the long term.
Acupuncture tends to have better outcomes than sham acu-
puncture, usual care, and no intervention. These favorable
effects of acupuncture involve complex interactions with the
patient, including empathy, intention, care, and attention, that
cannot be achieved by medications alone or by no intervention13.
In addition, endogenous chemicals released during the acu-
puncture process, such as enkephalin, dynorphin, and gamma-
aminobutyric acid, may have distinct effects for patients with
chronic knee pain13-16.
Marked heterogeneity was a limitation of the analysis of
the RCTs included in this study. The heterogeneity among
studies was evaluated using I2 inconsistency tests, in which
values of >50% were considered to indicate high heterogeneity.
One possible reason for the observed heterogeneity is that the
various acupuncturists performed the treatment without a
standardized protocol and according to their individual train-
ing and experiences. The variety of control interventions in-
cluded in this study (sham acupuncture, usual care, and no
intervention) may also have led to heterogeneity.
Previous meta-analyses have drawn various conclusions
depending on the types of control interventions used for com-
parison1,5,10. Although Manheimer et al. also showed that the pooled
effects of acupuncture were significantly superior to those of sham
treatment, the effects were believed to be clinically irrelevant5. In
addition, a recent meta-analysis of individual patient data showed
that acupuncture was associated with chronic pain relief when
compared with sham acupuncture and with no acupuncture35;
those results are in agreement with our findings.
The current study revealed some new findings that differ
from those of previous reports. First, when acupuncture was
compared with all control interventions simultaneously, pain
relief was not found to be sustained over time. In contrast, no
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Pain WMD (95% CI) Function WMD (95% CI)
20.95 (21.41 to 20.50) 3.68 (2.18 to 5.18)
20.95 (21.40 to 20.50) 3.68 (2.18 to 5.18)
21.02 (21.51 to 20.53) 4.24 (2.62 to 5.85)
previous systematic reviews evaluated the effect of pooled con-
trol interventions on pain relief.
Second, 2 recent high-quality RCTs have been included
here for the first time2,28. They showed no significant effects of
acupuncture compared with sham acupuncture or no treat-
ment, but both of the treatments did show pain relief and
functional improvement. Although they demonstrated the
beneficial effects of acupuncture on pain and physical disability,
their results could be explained by a placebo effect or patient
expectation. Using multivariable logistic regression, Chen et al.
found that active patients were significantly more likely to re-
port positive effects from acupuncture. They believed that a
prior positive expectation for an acupuncture effect strongly
predicted treatment success28. Hinman et al. used the Zelen
design to overcome the limitations of previous studies, with
patients having both positive and negative expectations of acu-
puncture being recruited2. The risk of recruitment bias was
minimized by blinding the control participants. They found
that laser and needle acupuncture were not superior to sham
acupuncture for pain relief or functional improvement. One
possible reason for this is that Hinman et al. eliminated the
expectation effect, which could expand the effect size difference
between acupuncture and sham acupuncture. Furthermore,
when compared with no acupuncture, acupuncture resulted
in only modest pain relief and functional improvement in the
short term. Curiously, no acupuncture control group tended
to improve even slightly in the long term. Based on the above
data, the findings of the 2 recent RCTs2,28 did not support the
effectiveness of acupuncture.
Although the 2 abovementioned recent studies did not
support acupuncture treatment, the results of our meta-analysis
are mainly positive. No evidence exists that positive attitudes
contributed to the previous positive results, although an ex-
pectation effect was identified and may have affected the results.
Moreover, the patients who held positive attitudes were ran-
domly assigned to the control and treatment groups, so the
expectation effect was attenuated.
This meta-analysis has some limitations. First, the in-
cluded RCTs compared a variety of control interventions;
therefore, definite conclusions regarding the various control
interventions are not possible. Larger and higher-quality trials
are needed to confirm these conclusions. Second, to avoid the
expectation effect, future studies should consider the patients’
attitudes regarding acupuncture prior to treatment. Third, the
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results were based on unadjusted estimates; a more precise
analysis should be conducted if individual patient data are
available, allowing adjustment for age, sex, ethnicity, and geo-
graphical location. Finally, the lack of standardization of acu-
puncture treatment protocols also limits our findings.
In conclusion, we believe that acupuncture can provide
superior pain relief and functional improvement compared with
sham acupuncture, usual care, and no intervention in the short
term. The effect on pain relief does not appear to be maintained
in the long term. Finally, the placebo effect of acupuncture may
contribute to its beneficial outcomes.
Appendix
A table showing the PRISMA checklist and figures com-
paring acupuncture with sham treatment, usual care, and
no intervention and showing funnel plots (overall and at each
time interval) are available with the online version of this article
as a data supplement at jbjs.org. n
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TH E E F F E C T S O F AC U P U N C T U R E ON C H R O N I C K N E E PA I N
DU E TO OS T E OA RT H R I T I S
Xianfeng Lin, MD1
Kangmao Huang, MD1
Guiqi Zhu, MD2
Zhaobo Huang, MD1
An Qin, MD, PhD3
Shunwu Fan, MD1
1Department of Orthopaedic Surgery, Sir Run Run Shaw Hospital,
Medical College of Zhejiang University, Hangzhou,
People’s Republic of China
2Department of Orthopaedic Surgery,
First Affiliated Hospital of Wenzhou Medical University,
Wenzhou, People’s Republic of China
3Department
of Orthopaedics, Shanghai Key Laboratory of
Orthopaedic Implants, Shanghai Ninth People’s Hospital,
Shanghai Jiaotong University School of Medicine, Shanghai,
People’s Republic of China
E-mail address for S. Fan: shunwu_fan@126.com
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