Hindawi Publishing Corporation
Evidence-Based Complementary and Alternative Medicine
Volume 2013, Article ID 427265, 7 pages
Ob�ectifying Speci�c and �onspeci�c ��ects of Acupuncture�A
Double-BlindedRandomisedTrial in Osteoarthritis of the Knee
Max Karner,1Frank Brazkiewicz,2Andrew Remppis,1,3Joachim Fischer,4Oliver Gerlach,5
1Department of Internal Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 410,
69120 Heidelberg, Germany
2Centre for Chinese Medicine, Universitätsallee 3, 28359 Bremen, Germany
3German Society for Traditional Chinese Medicine (DGTCM), Heidelberg University, Karlsruher Straße 12,
69126 Heidelberg, Germany
4Institute of Public Health, Social and Preventive Medicine, Mannheim Medical Faculty, Heidelberg University,
Ludolf-Krehl-Straße 7-11, 68167 Mannheim, Germany
5Shen-Centre for Traditional Chinese Medicine, Südliche Stadtmauer Straße 25, 91054 Erlangen, Germany
6Department of Society, Human Development and Health, Harvard School of Public Health, 677 Huntington Avenue,
Boston, MA 02115, USA
7Abel Salazar Biomedical Sciences Institute, University of Porto, Rua de Jorge Viterbo Ferreira No. 228,
4050-313 Porto, Portugal
Correspondence should be addressed to Henry Johannes Greten; firstname.lastname@example.org
Received 23 September 2012; Accepted 13 December 2012
Academic Editor: Jaung-Geng Lin
Copyright © 2013 Max Karner et al. is is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Introduction. Acupuncturewasrecentlyshowntobeeffectivein thetreatmentofkneeosteoarthritis.However,controversypersists
three different forms of acupuncture in a prospective randomised trial with a novel double-blinded study design. One-hundred
and sixteen patients aged from 35 to 82 with osteoarthritis of the knee were enrolled in three study centres. Interventions were
knee �exibility and changes in pain according to the WOMAC score. Results and Discussion. Improvement in knee �exibility was
for modern acupuncture, and 73 percent for classical acupuncture. Conclusion. is trial establishes a novel study design enabling
double blinding in acupuncture studies. e data suggest a speci�c effect of acupuncture in knee mobility and both non-speci�c
and speci�c effects of needling in pain relief.
Knee osteoarthritis is a major cause of morbidity, disability,
and health care utilisation, particularly in elderly patients
. e primary clinical manifestations are pain and joint
stiffness . erapy recommendations aim to improve
pharmacological approaches oen render limited effects and
also carry the burden of potentially serious side effects .
Hence, many patients try complementary medicine treat-
ments [5–7]. Amongst the nonpharmacological approaches,
the use of acupuncture has increased consistently during the
past few decades .
Recent randomised controlled trials have produced
rather contradictory results with respect to acupuncture’s
effects. Some trials have suggested a potential bene�t of
2 Evidence-Based Complementary and Alternative Medicine
acupuncture beyond that of sham or minimal acupuncture
[8–10], whereas other studies have reached the opposite
conclusion . ese inconsistent results have generated
much discussion in the scienti�c community as to whether
the effects in acupuncture were caused by mere skin pen-
etration or by the stimulation of speci�c points [12–16].
In an attempt to clarify this issue, we found corresponding
inconsistencies in the study designs themselves: the sham
or minimal acupuncture procedures used as controls in the
aforementioned trials differed systematically from the actual
acupuncture groups regarding number, size and length of
needles, and intensity and duration of the doctor-patient
encounter. Moreover, the trials failed to achieve complete
blinding [8–12]. Any attempt to clarify the issue of efficacy
in acupuncture requires a more controlled study design.
e controversy over acupuncture extends to the issue
of the most effective method of acupuncture . Some
practitioners favour a modern acupuncture, treating patients
Other practitioners adhere to an individualised classical
acupuncture, which derives acupuncture points from an
assessment of disease modalities and a physical examination,
including Chinese tongue and pulse diagnosis and the local-
isation of paraesthetic pressure points [18, 19].
To elucidate these open questions, we conducted a
repeated measures, double-blinded, and placebo-controlled,
multicentre trial in patients with chronic osteoarthritis of the
knee. e study compared the effects of three modalities of
acupuncture (sham, semistandardised modern and individ-
ualised classical) within two parameters: joint mobility and
pain [20, 21].
2. Materials and Methods
2.1. Patient Population. Patients aged 35 years or older were
recruited by newspaper advertisements and from the outpa-
tient clinics of the three participating centres. Potential par-
ticipants were �rst screened by telephone interview, followed
by a clinical examination to ascertain the satisfaction of the
diagnostic criteria of the American College of Rheumatology
and the presence of a severity grade of II or III according to
autoimmune disorders, surgery or arthroscopy during the
past 12 months, medication with steroids, physical therapy,
or acupuncture within the last four weeks, as well as intake
of opioids during the study period, were excluded from
the study. Patients were allowed to continue their regular
medication including NSAID or COX2-inhibitors while par-
ticipating in the study, but changes in medication and dosage
were not allowed. e local ethics committee approved the
protocol. All patients provided written informed consent.
2.2. Intervention, Randomisation, and Double Blinding.
Patients were informed that the study aimed to identify the
most effective of three acupuncture techniques, including
one sham technique. Participants were allocated in random
order to (a) the needling of non-speci�c points (sham), (b)
a semistandardised selection of disease-speci�c acupuncture
points as used in recent studies (modern acupuncture), and
(c) an individualised selection of acupuncture points deter-
mined by the diagnosis according to the traditional Chinese
medicine (classical acupuncture). Each patient received all
three forms of acupuncture (a, b, and c) in a random order.
Each session was spaced seven days apart resulting in one
single treatment per week as well as one single treatment per
form of acupuncture (a, b, and c). Prior to every acupuncture
session, a fully quali�ed and experienced physician and
acupuncturist established the Chinese medical diagnosis as
de�ned by the �eidelberg Model of Chinese medicine .
Using three differently coloured pens at random choice, the
�rst physician marked points for classical, modern, and sham
acupuncture. ereaer, the �rst physician informed the
study-coordinating centre about the colour allocation. e
study-coordinating centre compared these colour codings
to the sequence of treatment modalities according to a
computer-generated randomisation table and informed a
In all study centres, this second physician was a novice to
the observation of points. is apprentice practitioner was
instructed to maintain a standardised method as to needle
insertion or needle stimulation throughout all three sessions.
Aer acupuncture, the patients redressed with light garment
to cover any potential marks from needling. ereaer, the
patient returned to the �rst physician, who was unaware of
the used acupuncture method, for assessment of pain and
2.3. Acupuncture Technique. Acupuncture was performed
using 0.22 × 40mm copper needles. Only one knee was
treated in the study. Ear and hand acupuncture was not
allowed. During all sessions, the number of needles, the
type of needles, the depth of insertion, and the intensity of
stimulation were kept identical. In each session, ten points
± two points were allowed to be stimulated. e needles
were rotated immediately aer insertion and again aer 15
minutes. Needles were then withdrawn aer 30 minutes.
Communication with the patient during the acupuncture
e only systematic difference across the treatment
modalities was the location of needling points. Modern
acupuncture adhered to previously recommended methods
for selection of points for knee pain (ST36, ST34, EX32
twice, SP9, SP10, SP6, GB34, LI 4) [11, 23]. In addition,
up to three further points were admissible (e.g., ashi, LI3,
ST40). Non-speci�c needling used the points described
in Table 1. e points for the classical acupuncture were
determined individually for each patient according to the
classical Chinese diagnosis, which assessed the modality of
symptoms, complaints associated with certain movements,
acupuncture treatment, the classical acupuncture resulted in
a larger variation of needling points between patients with a
certain overlap to the points selected in modern acupuncture.
Evidence-Based Complementary and Alternative Medicine3
(Data were not shown; statistics on the selected points are
available from the authors.)
2.4. Outcome Measures. Reasoning that pain-related restric-
tions in knee �exibility are more direct external measure
of pain than subjective self-reported measures, we a priori
de�ned knee �exibility as the primary outcome measures
and the WOMAC scale as the secondary outcome param-
eter [24, 25]. Knee �exion was measured in standardised
fashion by using a universal goniometer, aligned with the
greater trochanter, through the lateral joint line to the lateral
malleolus. e �rst physician bent the knee to the point
at which pain limited further �exion. Knee �exibility was
measured before acupuncture, immediately thereaer, and
aer 7 days (for session two and three, the latter coincided
with the baseline-measurement prior to the next treatment).
acupuncture and immediately thereaer, as well as three and
seven days aer treatment. Change scores for either outcome
were calculated by subtraction of post- from preacupunc-
ture measurements, with a positive change score indicating
improvement. For dichotomous outcomes, a treatment suc-
cess was de�ned as an improvement of the knee �exibility by
by 50 percent or more, respectively.
2.5. Statistical Analysis. Knee �exibility as the primary out-
come parameter served to determine the sample size. An
improvement by 10 degrees was regarded as potentially
clinically relevant, and a difference of 5 degrees was viewed
as a marginal difference. Based on a pilot study, we estimated
a required total of 100 patients to obtain a power of 90%
at a type I error of less than 5% in order to demonstrate a
difference between methods in knee �exibility change scores
by 5 degrees (StateMate 2, Graphpad Soware Inc., San
Diego, CA, USA). We aimed to recruit 125 patients to allow
for dropout and noncompliance. Knee �exibility was shown
ing from the �rst randomisation. e main analysis com-
prised a two-factor analysis of variance (treatment modality
and time) with repeated measures. Least square means, 95%
con�dence intervals for knee �exion, and WOMAC scores
were estimated for each patient while taking into account
the covariates of gender, premedication (yes or no), disease
severity (Kellgren II versus Kellgren III), and number of
the Greenhouse-Geisser correction.
Repeated measures analysis of variance does not readily
provide for explicit modelling of possible carry-over effects.
or 3 might depend on the treatment of the preceding week.
erefore, we employed multilevel, hierarchical, random-
intercept, and random-slope modelling of the change scores
in knee �exion. In these models, we nested the six change
scores (immediately aer the treatment and 7 days aer the
treatment for all three modalities) within patients. e order
of treatment and the preceding treatment were entered as
modality were systematically explored with non-speci�c
needling and the �rst treatment as the respective reference
categories. Particular attention was given to the modelling
of carry-over effects from classical acupuncture to modern
acupuncture and vice versa. In a �nal step, we explored
random intercepts�random slopes of the �xed effects model,
as long as the −2log-likelihood value signi�cantly improved
[30, 31]. Blinding was maintained during the statistical
All analyses were on an intention-to-treat basis. Analyses
of variance were conducted using SPSS version 12 (SPSS
Inc., Chicago, IL, USA), multilevel modelling employing
MLwiN (Version 2.02, Multilevel Models Project, Institute of
Education, London, UK).
3. Resultsand Discussion
One-hundred and sixteen patients (mean age 62.4 years,
range = 40–83, 33% males) with chronic osteoarthritis of the
knee completed the study between April 2004 and May 2005.
distribution of gender, premedication, and disease severity
across the allocation for the �rst treatment modality (Table
ately aer the acupuncture procedure in 75 of 116 classical
acupuncture sessions, giving rise to a number needed to
treat (NNT) of 1.5 (95% con�dence interval 1.4 to 1.8);
this compared to 41 of 116 modern acupuncture sessions
(NNT = 2.9, 95% CI 2.2 to 3.8) and to 6 of 116 non-
speci�c needling sessions (NNT = 19, 95% CI 9.2 to 53,
𝑃𝑃 ? ?????). Classical acupuncture resulted in a signi�cantly
larger improvement immediately aer the treatment (Figure
2, mean change = 10.3 degrees, 95% CI 8.9 to 12) compared
to modern acupuncture (4.7 degrees, 95% CI 3.6 to 5.8),
while no effect was observed for non-speci�c needling (0.34
degrees, 95% CI—0.61 to 1.3; 𝐹𝐹 ? ????; 𝑑𝑑𝑑𝑑 ? ???, 358;
𝑃𝑃 ? ?????). Adjusting for the Kellgren classi�cation revealed
that the difference between classical acupuncture and modern
acupuncture was even larger in patients with more severe
illness (𝑃𝑃 ? ????).
e analysis of the change scores employing multilevel
modelling revealed signi�cant carry-over effects from the
When the �rst treatment consisted of classical acupuncture
(estimated mean change = 9.1 degrees, 95% CI 6.2 to 13),
the effects from modern acupuncture (mean change = 0.7
degrees, 95% CI—1.3 to 2.7) were negligible. However, when
the �rst treatment consisted of modern acupuncture (mean
change = 5.5 degrees, 95% CI 3.1 to 7.9), subsequent classical
acupuncture resulted in a further �exibility gain (mean
from the values reported in the preceding paragraph arise
from the adjustment for carry-over effects.
4 Evidence-Based Complementary and Alternative Medicine
T 1: Acupuncture points chosen for nonspeci�c needling.
(i) A point between the gallbladder and stomach conduit at the posterior edge of the �bula 2 cun above the malleolus lateralis
(ii) A point 2 cun and 6 cun, respectively, above the malleolus medialis on the tibial surface (intracutaneous needling without
contact to the periost with the needles pointing to the knee)
(iii) A point in the middle of the thigh on a line between the patella and the anterior iliac spine
(iv) A point at the top of the contracted biceps muscle
To equalise the number of needles employed between the different needling modalities, the following additional points were
(i) A point 3 cun above and medial to the cle of the knee joint between the spleen conduit and the renal conduit
(ii) A point in the middle of a line between liver 13 and liver 16
(iii) A point in the middle of a line between gallbladder 37 and vesical 58
(iv) A point 2 cun dorsal to gallbladder 32
(v) A point in the middle of a line between heart 2 and pericardium 3
348 patients applied for participation
190 screened by orthopaedic specialist
133 satisfied inclusion criteria
125 started trial, randomised
43 CA first,
41 MA first,
41 NA first,
158 excluded by
47 excluded during
1 screening failure
7 missed first session
9 lost to follow-up
during study or
116 completed trial
3 lost to followup 4 lost to followup
2 lost to followup
F 1: Patient recruitment, randomisation and followup.
e multilevel model also suggests that the substan-
tial variation between patients in the effects of classical
acupuncture is relatively independent of the variation in the
effect of modern acupuncture—in other words, the extent
of improvement aer classical acupuncture is not correlated
with the extent of improvement aer modern acupuncture
(𝑃𝑃 ? ????forthecovarianceintherandompartofthemodel).
In contrast to the differences in efficacy for knee mobil-
ity, all three treatment forms resulted in some immediate
improvement of pain scores (Figure 3). Classical acupuncture
showed a signi�cantly larger improvement immediately aer
treatment than non-speci�c needling did (post-hoc contrast,
𝐹𝐹 ? ???, 𝑑𝑑𝑑𝑑 ? ?, 𝑃𝑃 ? ?????). �uccess rates de�ned as
a WOMAC reduction by 50% were the largest immediately
aer classical acupuncture (85 of 116, NNT 1.4, 95% CI
1.23–1.56) as compared to modern acupuncture (74 of 116,
NNT 1.56, 95% CI 1.38 to 1.84, nonsigni�cant difference)
and non-speci�c needling (56 of 116, NNT 2.1, 95% CI
1.68–2.46,𝑃𝑃 ? ????).epainrelievingeffectofanyneedling
rapidly declined. At the 7-day follow-up visit, pain scores
were similar across the three methods (Figure 3).
3.1. Strengths and Weaknesses. e strength of the present
study is its use of a novel study design for acupuncture
which establishes blinding of both patients and the treating
physicians. is design overcame major shortcomings of
previous studies which failed to achieve adequate blinding
and in which sham treatment usually differed substantially
from acupuncture. e results of the present study offer
an answer to the basic question of whether the effects in
acupuncture are speci�c or caused by mere skin penetration.
between the three treatment modalities, approximating for
the �rst time the principles of randomised and double-
blinded, controlled trials in acupuncture studies.
116 patients with osteoarthritis of the knee received
three treatments in a random order: acupuncture according
to an individualised diagnosis of Chinese medicine (clas-
sical acupuncture), a semistandardised modern version of
acupuncture) and non-speci�c needling. e main �ndings
Evidence-Based Complementary and Alternative Medicine5
T 2: Patient characteristics.
Gender male (percent)
Kellgren Grade III (percent)
Le knee (percent)
Duration of pain (years)
CA: classical acupuncture� MA: semistandardised modern acupuncture� �A: nonspeci�c needling. Columns describe the �rst treatment. All patients
subsequently received the two remaining treatment modalities.
CA as �rst treatment
MA as �rst treatment
�A as �rst treatment
Knee flexion (degrees)
F 2: Knee �exion before and aer acupuncture. e �gure
compares the maximum possible knee movement until further
�exion was blocked by pain for classical acupuncture, semistan-
dardised modern acupuncture, and non-speci�c needling. Flexion
was assessed immediately prior to treatment, directly thereaer
and at a recall visit aer 7 days. Data display the means adjusted
for Kellgren classi�cation, prior intake of medication, and patient
gender. Error bars indicate the standard error of the mean. Knee
modern acupuncture (4.7 degrees) and no change aer non-
speci�c needling (0.3 degrees). e largest improvements in
pain were also seen immediately aer classical acupuncture
(a WOMAC score reduction by 50% or more in 85 of 116
patients)� however, non-speci�c needling also achieved con-
siderable effects (core reduction by 50% in 56 of 116 patients,
classical acupuncture. erefore, the present data suggest
substantial non-speci�c effects in subjective pain relief. In
contrast to subjective pain relief, however, improvements in
knee �exibility as objective outcome measure were only seen
aer the needling of speci�cally selected points and not aer
WOMAC pain score
F 3: WOMAC pain scores before and aer acupuncture. e
�gure compares the WOMAC pain scores for classical acupuncture,
semistandardised modern acupuncture, and non-speci�c needling.
Pain was assessed immediately prior to acupuncture, directly there-
aer, by self-administered questionnaire at home at 3 days aer
adjusted for Kellgren classi�cation, prior intake of medication, and
patient gender. Error bars indicate the standard error of the mean.
to exclude bias caused by differences in the control arms.
earlier �ndings. e measure of effect observed for the sham
acupuncture as well as for the semistandardised modern
acupuncture was similar to those previously observed in
multicentre trials. Pain relief of comparable effect can also be
achieved by other methods such as transcutaneous electrical
nerve stimulation, supporting the notion that neurogenic
pain contributes to the symptoms in patients with degener-
ative changes in joints [32, 33]. �owever, the non-speci�c
effects of acupuncture may exceed those of mere placebo
effects , for reasons as yet unexplained.
6Evidence-Based Complementary and Alternative Medicine
Interestingly aer seven days, no relevant difference in
pain scale was reported, although we found the signi�cant
changes in knee motility to be persistent among the three
be considered an indirect measure of pain relief as pain is the
main limiting factor for knee motility.
Moreover, we observed a rapid improvement of knee
twice the effect observed aer modern acupuncture and
absent aer non-speci�c needling. Elucidating the physio-
logical mechanisms [35–38] underlying this method-speci�c
Experimental data, however, offer some possible explana-
exclude structural changes in the affected joints as the
underlying mechanism of acupuncture in this experimental
setting, they do, however, indicate an underlying neural
mechanism . It remains speculative as to whether this
re�ex-like effect involves functional changes within higher
regions of the central nervous system or whether regional
effects on musculoskeletal dynamics and connective tissue
structures may be the dominant mechanism. e observed
immediate effects, however, make a primarily systemic or
humoral effect rather unlikely. As the systematic search for
of history taking and work-up for the Chinese diagnosis, it is
conceivable that the individualised diagnostic approach may
enhance the chance to effectively identify needling points
with the potential for reducing functional limitations. e
present study suggests that the methodology of arriving at
acupuncture points may matter. In the present study, classi-
cal acupuncture outperformed modern acupuncture. Future
in the study design.
3.2. Limitations. Several caveats of the present investigation
require consideration. Firstly, we studied each acupuncture
technique only once in each patient, and treatments were
usually one week apart. us, we are unable to infer the
long-term or cumulative effects of repeated applications; the
study should, therefore, be considered a proof of concept
e available data from the present study corroborate
a rapid decline, particularly of the non-speci�c pain relief
effect, within one week. Secondly, the present data sug-
gest that effects on knee mobility are somewhat retained.
However, the imperfect retest reliability of repeated knee-
�exion measures aer one week suggests viewing this result
with caution and encourages repetition in other studies.
irdly, crossover designs are prone to carry-over effects.
We cannot rule out residual carry-over effects beyond those
explicitly modelled within the multilevel statistical method.
Finally, while the data support the notion that the choice of
needling points matters, the relevant aspects of the Chinese
diagnosis still remain to be elucidated. is, however, cannot
be addressed in this work.
In summary, our double-blinded and randomised crossover
study provides a novel study design for assessing efficacy in
acupuncture and establishes a framework for addressing the
question as to whether the speci�c choice of acupuncture
points matters. e study was conducted in osteoarthritis
of the knee, and the outcome measures are self-reported
pain relief and knee motility. As to the �rst, non-speci�c
needling achieved about two-thirds of the subjective pain
relief achieved aer classical acupuncture, suggesting con-
siderable non-speci�c effects. With respect to knee motility,
of semistandardised modern acupuncture. No change, how-
ever, was observed aer non-speci�c needling. is suggests
In the scienti�c discussion about efficacy of acupuncture,
our data suggests that it bears both speci�c and non-speci�c
effects, and the selection of acupuncture points for treatment
does appear to be relevant.
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