RESEARCH Open Access
Evaluation of wet-cupping therapy for persistent
non-specific low back pain: a randomised,
waiting-list controlled, open-label, parallel-group
Jong-In Kim1,2†, Tae-Hun Kim1,2†, Myeong Soo Lee1, Jung Won Kang1,2, Kun Hyung Kim1,2, Jun-Yong Choi1,3,
Kyung-Won Kang1, Ae-Ran Kim1, Mi-Suk Shin1, So-Young Jung1and Sun-mi Choi1*
Background: Persistent non-specific low back pain (PNSLBP) is one of the most frequently experienced types of
back pain around the world. Wet-cupping is a common intervention for various pain conditions, especially in
Korea. In this context, we conducted a pilot study to determine the effectiveness and safety of wet-cupping
treatment for PNSLBP.
Methods: We recruited 32 participants (21 in the wet-cupping group and 11 in the waiting-list group) who had
been having PNSLBP for at least 3 months. The participants were recruited at the clinical research centre of the
Korea Institute of Oriental Medicine, Korea. Eligible participants were randomly allocated to wet-cupping and
waiting-list groups. Following the practice of traditional Korean medicine, the treatment group was provided with
wet-cupping treatment at two acupuncture points among the BL23, BL24 and BL25 6 times within 2 weeks. Usual
care, including providing brochures for exercise, general advice for PNSLBP and acetaminophen, was allowed in
both groups. Separate assessors participated in the outcome assessment. We used the 0 to100 numerical rating
scale (NRS) for pain, the McGill Pain Questionnaire for pain intensity (PPI) and the Oswestry Disability Questionnaire
(ODQ), and we assessed acetaminophen use and safety issues.
Results: The results showed that the NRS score for pain decreased (-16.0 [95% CI: -24.4 to -7.7] in the wet-cupping
group and -9.1 [-18.1 to -0.1] in the waiting-list group), but there was no statistical difference between the groups
(p = 0.52). However, the PPI scores showed significant differences between the two groups (-1.2 [-1.6 to -0.8] for
the wet-cupping group and -0.2 [-0.8 to 0.4] for the waiting-list group, p < 0.01). In addition, less acetaminophen
was used in the wet-cupping group during 4 weeks (p = 0.09). The ODQ score did not show significant differences
between the two groups (-5.60 [-8.90 to -2.30] in the wet-cupping group and -1.8 [-5.8 to 2.2] in the waiting-list
group, p = 0.14). There was no report of adverse events due to wet-cupping.
Conclusion: This pilot study may provide preliminary data on the effectiveness and safety of wet-cupping
treatments for PNSLBP. Future full-scale randomised controlled trials will be needed to provide firm evidence of the
effectiveness of this intervention.
Trial Registration: ClinicalTrials.gov: (Identifier: NCT00925951)
Date of trial registration: June 19th, 2009
The date when the first patient was randomised: July 15th, 2009
The date when the study was completed: November 27th, 2009
* Correspondence: firstname.lastname@example.org
† Contributed equally
1Korea Institute of Oriental Medicine, Daejeon, Republic of Korea
Full list of author information is available at the end of the article
Kim et al. Trials 2011, 12:146
© 2011 Kim et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
Persistent non-specific low back pain (PNSLBP) is one
of the most common pain disorders in primary care .
Eighty percent of the population experiences low back
pain at least once in a lifetime , and 60% of the
patients have recurrences . Importantly, in 85% of all
patients, the symptoms are not attributed to particular
aetiological or neurologic causes , and in 23% of the
patients, they are sustained for more than 12 weeks, a
chronic condition . In the medical insurance reimbur-
sement system for traditional Korean medicine (TKM),
PNSLBP is one of the highest ranked disorders in terms
of medical expenses for both outpatients and inpatients
Wet-cupping has been used as an alternative treat-
ment method throughout the world, especially in Asia,
the Middle East  and Europe . The main purpose
of this therapy in TKM is to precipitate the circulation
of blood and qi and to remove blood-stasis and waste
from the body. According to a survey on the use of cup-
ping therapy in Korea, 90.8% of practitioners have used
wet-cupping; this reflects the fact that wet-cupping is a
widely used treatment modality in TKM [9,10].
Although there have been some published trials evalu-
ating wet-cupping for pain, the evidence for its effective-
ness is not well established because of methodological
limitations and the scarcity of clinical trials . Rigor-
ous, well-designed trials are urgently needed to evaluate
the effectiveness of wet-cupping for pain. This study
was designed to rigorously and objectively evaluate the
applicability of a wet-cupping treatment for PNSLBP.
This was a randomised, waiting-list controlled, open-
label, parallel pilot trial evaluating the effectiveness,
safety and feasibility of a wet-cupping treatment for
PNSLBP. PNSLBP is defined as continued low back pain
for at least 12 weeks without recognisable specific
causes such as radicular syndrome, infection or tumour
[12,13]. We recruited participants through advertise-
ments in local newspapers or on the website of a local
university in Daejeon Province. Participants visited the
clinical research centre of the Korea Institute of Oriental
Medicine (KIOM) at Doonsan Oriental Hospital of Dae-
jeon University (DOHDU), and their eligibility was
determined by a physician and a radiologist through
physical exams and radiological tests, respectively, and
relevant questionnaires. Men and women aged 20-60
years were recruited. Those who did not meet the defi-
nition of PNSLBP or who were not suitable for wet-cup-
ping treatment due to medical conditions (e.g.,
haematologic disease, anticoagulant use or systemic dis-
ease, such as diabetes and cardiovascular or renal dis-
ease) were excluded. To improve the credibility of the
study, we excluded those who had undergone cupping
or alternative therapies during the previous 3 months
and any therapies for PNSLBP during the previous 2
Because an additional purpose of this trial was to esti-
mate the sample size for a large scale randomised con-
trolled trial (RCT), we decided to recruit at least 30
participants. It has been suggested that 30 participants
is a reasonable sample size for a pilot study to detect a
medium to large effect size . Participants were allo-
cated to the treatment group or control group at a ratio
of 2 to 1. Random numbers were generated by a statisti-
cal expert with the block randomisation method using a
computer software package (SAS®Version 9.1.3, SAS
institute. Inc., Cary, NC). During the trial, the randomi-
sation table could not be accessed by anyone involved in
this study, except the statistician. Sealed opaque envel-
opes with serial numbers were used for allocation con-
cealment. Based on the registered number of a
participant, the envelope with the matching number was
opened, and the result of the allocation was announced
to the participant .
Before allocation, the expectations of every participant
regarding wet-cupping therapy were assessed. The ques-
tion asked was “Would you expect a good prognosis
with wet-cupping therapyż” A 7-point Likert scale (from
0- ‘Not at all’ to 6- ‘Very positive’) was used for
The study protocol was approved by the institutional
review board (IRB) of DOHDU, and it was registered at
http://ClinicalTrials.gov (Identifier: NCT00925951).
Signed informed consent was obtained from every parti-
cipant before beginning the study.
Participants who were assigned to the treatment group
received wet-cupping therapy 3 times per week for 2
weeks. Safety was one of the most important issues in
this study. We used 40 cc disposable cups (Seongho
trade & company, Korea) and disposable caps for the
auto-lancets. In addition, to avoid possible adverse
events related to the wet-cupping procedure, practi-
tioners treated participants according to the pre-defined
clean wet-cupping technique procedure (Table 1). Treat-
ment points were located bilaterally at BL23, BL24 and
BL25 according to the WHO Guideline for Acupuncture
Point Locations [16,17]. Each time, the practitioners
chose 2 points that were the most painful sites of the
points when pressed and palpated manually. We chose
BL23, BL24 and BL25 for treatment points because
these points are located in the low back and are the
painful points where back pain patients usually feel dis-
comfort. These points are also frequently used in TKM
to treat PNSLBP. In the case where there were no
Kim et al. Trials 2011, 12:146
Page 2 of 7
painful points, we chose the bilateral BL25. The practi-
tioners had to have at least 3 years of clinical experience
after the 6-year TKM education.
Participants were prohibited from using any medical
treatment for improving PNSLBP symptoms, including
both drug and physical therapy, for 4 weeks. We offered
a brochure about exercise, general advice for PNSLBP
and 500 mg acetaminophen tablets (Janssen Korea,
Korea) to both groups. The recommended exercise pro-
gram consisted of 8 types of stretching and strengthen-
ing exercise. The frequency and intensity of the exercise
program remained flexible. The participants were per-
mitted to take up to 3 tablets acetaminophen per day to
relieve PNSLBP. Lumbar supports and hot packs could
also be used. However, medicine such as tricyclic anti-
depressants, muscle relaxants, non-steroidal anti-inflam-
matory drugs (NSAIDs), opioids or amino acid
antiepileptic drugs and therapeutics such as interferen-
tial therapy, laser therapy, short wave diathermy, trac-
tion, transcutaneous electrical nerve stimulation (TENS),
manipulation, massage, acupuncture, injections, nerve
block, neuroreflexotherapy, percutaneous electrical
nerve stimulation, spinal cord stimulation or surgery,
which could be effective for PNSLBP, were forbidden.
Two measures were used to assess outcome: pain and
functioning. The primary outcome was a difference in
the changes in the numerical rating scale (NRS) for pain
from baseline to the end of the 2-week treatment (pri-
mary end point) between the wet-cupping and waiting-
list groups. Secondary outcomes were the present pain
intensity from the McGill Pain Questionnaire (PPI) ,
scores on the Oswestry Disability Questionnaire (ODQ)
 and the number of acetaminophen tablets used
. The validated Korean versions of all outcome
assessments were used [21-23].
The NRS, which assessed the general status of pain
during the last 7 days, used a 0 to 100 point scale,
where zero corresponded to no pain and 100 to the
extreme pain . The minimum clinically important
difference (MCID) for NRS was suggested to be 15
points . The PPI, which is a part of the McGill Pain
Questionnaire, described current pain from 0 (no pain)
to 5 (excruciating pain) scales . The ODQ score was
used to measure disability due to PNSLBP; 10 items on
the severity of disability for daily activities, such as
washing hands, walking, sitting and standing, were
included in this questionnaire. Each item has a 6-point
rating scale, and the total scores varied from 0 to 50.
The ODQ score is calculated with the following for-
mula: [(total score)/ (total possible score)]*100. The
MCID for ODQ score was suggested to be 10 points
. The number of acetaminophen pills used during
the 4 weeks was also assessed with patient reports at the
last visit of every participant . An adverse event was
defined as any unintended indication, symptom or dis-
ease, regardless of the intervention (wet-cupping and
waiting-list). Adverse events were ascertained through
the reports by participants and physical examination by
practitioners at every visit. The severity of the adverse
event was classified by practitioners as grade 1 (mild) to
4 (life threatening), according to the criteria of World
Health Organization (WHO Toxicity Grading Scale for
Determining The Severity of Adverse Events) .
Statistical analysis, patients’ expectation and
Statistical analysis was based on the intention-to-treat
principle, and p-values less than 0.05 were considered
significant. The last observation carried forward method
was used for the amendment of missing data. After the
Kolmogorov-Smirnov test was performed to evaluate
normality, statistical analysis of the outcome variables
was conducted with a Wilcoxon rank sum test or the
analysis of covariance (ANCOVA): the baseline values of
each outcome variable were used as a covariate. Statisti-
cal analysis was conducted using a software package
(SAS®Version 9.1.3, SAS Institute. Inc., Cary, NC).
All 62 participants were assessed for eligibility, and 30
were excluded in the screening test. Of the participants
excluded, 13 were excluded because they were diag-
nosed with radiculopathy (herniated nucleus pulposus).
Other specific reasons for exclusion were renal stone (n
= 1) and spondylolisthesis (n = 2). The remaining 32
participants were randomly allocated to the wet-cupping
group (n = 21) and the waiting-list group (n = 11) (Fig-
Table 1 Clean Wet-Cupping Technique
1 Wear sterilised gloves.
2 Find points for wet-cupping and indicate the sites by surgical
3 Swab with 10% potadine solution and put a disposable cap to auto-
4 Punctuate 6 points along the marked site in 2 mm-depth and attach
cups on the skin.
5 Exhaust inner air of the cups with maximum negative pressure by
6 Retain the cups for 5 minutes.
7 Open the exhausting valve and remove the cup.
8 Swab and stanch the treated sites with 10% potadine solution and
9 Let the participant rest for 5 minutes.
Kim et al. Trials 2011, 12:146
Page 3 of 7
Because baseline characteristics, including age, dura-
tion of PNSLBP, sex and body mass index (BMI) as well
as severity of pain (NRS and PPI) and disability (ODQ),
showed no differences between the two groups (Table
2), the randomisation process was considered to have
been done successfully [15,29].
The expectation for wet-cupping therapy between the
two groups did not show a statistically significant differ-
ence (p = 0.94, Chi-squared test).
The NRS scores for pain after treatment was 42.0 [95%
CI: 32.5 to 51.6] in the wet-cupping group and 43.6
[35.2 to 52.1] in the waiting-list group. The changes in
the NRS scores from baseline to the primary end point
(after the 2-week treatment) in the wet-cupping and
waiting-list groups were -16.0 [-24.4 to -7.7] and -9.1
[-18.1 to -0.1], respectively. Although the difference
between the two groups was not statistically significant
(p = 0.37, ANCOVA), NRS scores in the wet-cupping
group showed improvement larger than the value of
MCID, -15. The analgesic effect was maintained after 2
weeks of follow up, but at this later follow-up, there
was no significant difference between the two groups
(-18.2 [-26.0 to -10.4] in the wet-cupping group, -9.1
[-17.4 to -0.8] in the waiting-list group, p = 0.15) (Fig-
The PPI after treatment was 1.2 [1.0 to 1.5] in the
wet-cupping group and 1.7 [1.3 to 2.2] in the waiting-
list group. The changes in the baseline to primary
end point PPI scores showed a statistically significant
difference between the two groups (-1.2 [-1.6 to -0.8]
and -0.2 [-0.8 to 0.4], p < 0.01, ANCOVA). Because
30% improvement from the baseline score from PPI
meets MCID, it can be concluded that wet-cupping
treatment improved current pain over the MCID, as a
50% change was reported . After 2 weeks of fol-
low up, a significant reduction in perceived current
pain continued in the wet-cupping group (-1.3 [-1.7
to -0.8], -0.4 [-1.0 to 0.3], p < 0.01, ANCOVA) (Fig-
Figure 1 The CONSORT flow chart.
Table 2 Demographic Data and Baseline Outcome Values in the Wet-cupping and Waiting-list Groups
Characteristics Wet-cupping group (n = 21)Waiting-list group (n = 11)
Sex M/F No.
Duration of illness (m)
(1) Pain intensity
(2) Personal care
(8) Sex life
(9) Social life
ODQ score (%)
2. 3.19, 0.68
3. 3.18, 0.60
Values are expressed as mean, standard deviation. BMI(kg/m2): body mass index; NRS: numeric rating scale; PPI: present pain index; ODQ: Oswestry disability
Kim et al. Trials 2011, 12:146
Page 4 of 7
The total ODQ scores (%) after 2 weeks of treatment
were 42.3 [36.6 to 48.0] in the wet-cupping group and
46.2 [40.5 to 51.9] in the waiting-list group. The changes
in the total ODQ scores from baseline to the primary
end points were -5.6 [-8.9 to -2.3] and -1.8 [-5.8 to 2.2],
respectively (p > 0.05, Wilcoxon rank sum test). There
was no statistically significant difference in the change
of total ODQ scores from baseline to after 2 weeks of
follow up (-7.3 [-10.9 to -3.7] in the wet-cupping group,
-4.9 [-10.8 to 1.0] in the waiting-list group, p > 0.05,
Wilcoxon rank sum test). Because the MCID of the
ODQ was suggested to be -10, patients did not show
clinically significant improvements in disability after
wet-cupping treatment .
The amount of acetaminophen used and safety issues
During the 4 weeks of the study, the mean number of
acetaminophen pills taken was 0.9 [0.0 to 1.8] in the
wet-cupping group and 5.7 [0.0 to 11.7] in the waiting-
list group, respectively (p = 0.09, Wilcoxon rank sum
test). No adverse events were reported.
The primary purpose of this trial was to test the applic-
ability of wet-cupping treatment for PNSLBP patients.
The recruitment of participants for this study was not
difficult and was achieved through a local advertisement
for PNSLBP. The main reason for such a good participa-
tion rate might be related to the belief of the general
Korean population in the favourable effects of wet-cup-
ping on PNSLBP [9,10]. On the other hand, about half
of all participants (30 out of 62) were excluded because
they did not meet the inclusion criteria due to specific
medical conditions, including renal stones and other
structural abnormalities of the spine. Thus, in addition
to the symptom assessment to exclude patients with
conditions unrelated to PNSLBP , it also seems
important to perform an X-ray and a physical examina-
tion of PNSLBP patients during the diagnostic process.
The outcome measurements used in this study seem
to be suitable for evaluating the pain and disability of
PNSLBP patients and for assessing the therapeutic effect
of wet-cupping. It is worth noting that there was an
inconsistency between the NRS and PPI results. This
result was partially caused by the two outcomes measur-
ing different aspects of pain: NRS was the value for pain
in the past 7 days, and PPI was the value for present
pain. Additionally, the inconsistency might be related to
the insufficient statistical power for testing effectiveness.
The result of a sample size calculation with the primary
outcome (NRS changes) of this study, adopting 0.05 for
a, 0.2 for b and 20% for drop-out rate, suggested that
115 participants in each group are an adequate sample
size. However, apart from this inconsistency, partici-
pants experienced pain reduction, at least MCIDs, in
both PPI and NRS measures, which implies the clinical
value of wet-cupping therapy for PNSLBP in clinical
practice. In this sense, future clinical trials should con-
sider the intergroup differences for pain as well as
MCIDs in the evaluation of NRS and PPI.
The second purpose of this study was to evaluate the
basic effectiveness of wet-cupping. Some studies have
suggested that wet-cupping has favourable effects on
PNSLBP [7,11]. Although a significant change in the
NRS was not observed, wet-cupping appears to be effec-
tive in reducing present pain (measures with the PPI
score) as well as decreasing the use of analgesics (total
count of acetaminophen) in this study. Considering the
small sample size of the study, it seems not to be
Figure 2 The change in the numeric rating scale (NRS) of pain.
Figure 3 The change in the present pain intensity of the McGill
Pain Questionnaire (PPI).
Kim et al. Trials 2011, 12:146
Page 5 of 7
important that functional improvement (ODQ score)
was not great enough to show a significant difference
If wet-cupping is effective, what might be the possible
physiological mechanisms? We can only speculate on a
hypothetical mechanism because there are very few stu-
dies in the literature that might provide clues . It
has been suggested that wet-cupping analgesia is similar
to the effect of acupuncture and occurs via segmental,
extra-segmental and central regulatory action . How-
ever, the shape and target of stimulation in acupuncture
and wet-cupping are different; thus, assuming an exact
correspondence in their mechanisms of action seems
The wet-cupping procedure generally consists of lacer-
ating the skin, creating a vacuum on the skin and
extracting a small amount of blood . Local damage
of the skin and capillary vessels takes place in this pro-
cedure, and it may act as a nociceptive stimulus, which
triggers diffuse noxious inhibitory control (DNIC) .
It has been reported that chronic musculoskeletal pain
has an affective component . Even light touch can
help to relieve pain associated with the affective compo-
nent through the limbic response . Therefore, the
tactile stimulus of wet-cupping may be related to the
analgesic effect. Future experimental studies are needed
to examine the anti-pain effect related to wet-cupping
To minimise bias and the observation of non-specific
effects, clinical trials should compare drugs or interven-
tions to placebo or sham controls . We did not use
a sham device as a control in this trial. However, the
practitioners and the outcome assessors were different,
which helped to keep the outcome assessment objective.
To evaluate the specific effect of the cupping treatment,
clinical trials with sham devices are necessary. A vali-
dated sham cupping device has been developed recently
. Therefore, an efficacy trial with a sham cupping
device can be conducted in the future.
In addition to the evaluation of effectiveness, safety
issues are very important when using wet-cupping in
practice. In conventional wet-cupping, a non-sterile,
reused cup and lancet are used without any considera-
tion of the possibility of infection. We administered
wet-cupping following pre-specified sterile procedure
guidelines with a disposable cup and lancet. No adverse
events were reported in this study. Single-use medical
devices (SUMED) should not be reused, but reuse is
very common, especially in developing countries,
because of the different beliefs of patients and health
care providers and limited medical resources . The
reuse of medical devices has a potential danger of infec-
tion transmitted through blood and body fluids. A clean
technique should be considered for the safe application
of wet-cupping in clinical practice.
Cupping is a commonly used traditional intervention
with a wide application all around the world for various
conditions: pain [11,37], hypertension  and stroke
rehabilitation . Despite its common use, recent sys-
tematic reviews have suggested that the evidence for
wet-cupping is not sufficient to make a firm conclusion.
Methodological flaws and the scarcity of good RCTs are
the main reason for the negative results. To establish
the effectiveness and safety of cupping therapy, rigorous
studies are needed in the future.
The result of this study implies that wet-cupping may
have a potential effect to reduce current pain associated
with PNSLBP. However, it is difficult to firmly conclude
that wet-cupping is a meaningful intervention for func-
tional recovery from PNSLBP. A large scale sham cup-
ping-controlled trial would be necessary for evaluating
the efficacy of wet-cupping therapy for PNSLBP in the
Conflicts of interest
The authors declare that they have no competing
List of abbreviations
ANCOVA: analysis of covariance; DOHDU: Doonsan Oriental Hospital of
Daejeon University; KIOM: Korea Institute of Oriental Medicine; TKM:
traditional Korean medicine; NRS: numerical rating scale; NSAIDs: non-
steroidal anti-inflammatory drugs; ODQ: Oswestry Disability Questionnaire;
PNSLBP: Persistent non-specific low back pain; PPI: McGill Pain Questionnaire
for pain intensity; RCT: randomised controlled trial; TENS: transcutaneous
electrical nerve stimulation.
This study is supported by the Development of Acupuncture, Moxibustion
and Meridian Standard Health Technology Project (K11010) of the Korea
Institute of Oriental Medicine.
1Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.2College of
Oriental Medicine, Kyung Hee University, Seoul, Republic of Korea.3School of
Korean Medicine, Pusan National University, Yangsan, Republic of Korea.
JIK and THK participated in the design of this clinical trial. THK drafted this
manuscript. JIK, THK, JYC, ARK, MSM, SYJ and SMC conducted the clinical
trial. JIK, THK, MSL, KHK and JWK participated in the critical revision of the
manuscript. KWK participated in the sequence generation process and the
statistical analyses. SMC was the general supervisor for this research and
participated in both the study design and critical revision of the manuscript.
All authors read and approved the final manuscript.
Received: 9 March 2011 Accepted: 10 June 2011
Published: 10 June 2011
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Cite this article as: Kim et al.: Evaluation of wet-cupping therapy for
persistent non-specific low back pain: a randomised, waiting-list
controlled, open-label, parallel-group pilot trial. Trials 2011 12:146.
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Kim et al. Trials 2011, 12:146
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