Acupuncture for post-stroke upper limb pain (Protocol)

Liang CM, Peng W, Ma XJ

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2011, Issue 4
http://www.thecochranelibrary.com

Acupuncture for post-stroke upper limb pain (Protocol)

Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
ACKNOWLEDGEMENTS
. . .
REFERENCES . . . . . . . .
APPENDICES . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .

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Acupuncture for post-stroke upper limb pain (Protocol)

Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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[Intervention Protocol]

Acupuncture for post-stroke upper limb pain

Cui Mei Liang1 , Weina Peng1 , Xiao Jing Ma1
1 Department

of Acupuncture and Moxibustion, Guang An Men Hospital, China Academy of Chinese Medical Sciences, Beijing,

China
Contact address: Cui Mei Liang, Department of Acupuncture and Moxibustion, Guang An Men Hospital, China Academy of Chinese
Medical Sciences, No. 5, Bei Xian Ge Street, Xuanwu district, Beijing, 100053, China. christine_lcm@live.cn.
Editorial group: Cochrane Stroke Group.
Publication status and date: New, published in Issue 4, 2011.
Citation: Liang CM, Peng W, Ma XJ. Acupuncture for post-stroke upper limb pain. Cochrane Database of Systematic Reviews 2011,
Issue 4. Art. No.: CD009087. DOI: 10.1002/14651858.CD009087.
Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To assess the efficacy and possible adverse effects of acupuncture for the treatment of post-stroke upper limb pain.

Acupuncture for post-stroke upper limb pain (Protocol)

Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

BACKGROUND
medicine, has recently gained popularity within Western medicine
(Johansson 1993; NIH 1998; NS 2007; Singer 2006).

Description of the condition

Stroke is the third leading cause of death in the world (Bonita
1990). In China, it is the second most common cause of death
in cities and the third most common cause of death in rural areas (MOH PRC 1999). Stroke survivors frequently experience a
variety of chronic pain syndromes resulting from stroke-induced
damage to the nervous system (neuropathic pain). Patients who
have a seriously weakened or paralysed arm commonly experience
moderate-to-severe pain that radiates outward from the shoulder
(NIH 2008). Pain in the affected upper limb is a common complaint in post-stroke patients. It usually affects the shoulder joint
and, less frequently, the wrist and hand (Zyluk 2006). Longitudinal studies suggest that three-quarters of patients will develop
shoulder pain during the 12 months after stroke (Roy 1994; Van
Ouwenaller 1986; Wanklyn 1996). Pain is usually accompanied
by limited mobility of the shoulder and sometimes by swelling of
the hand and wrist (Zyluk 2006). These complaints affect women
more frequently than men, younger patients and those who initially had more severe paresis (Zyluk 2006). Stroke patients who
suffer upper limb pain most commonly have lesions in the thalamus basal ganglia or temporal lobe, regardless of whether the
underlying pathology was cerebral haemorrhage or cerebral infarction (Bai 2004). If the pain involves both the shoulder and hand,
with accompanying swelling, trophic changes and vasomotor disturbances, this may fulfil the criteria for the diagnosis of shoulder-hand syndrome. Shoulder-hand syndrome is one of the more
severe complications seen in stroke patients and can become irreversible without appropriate timely intervention (AAFP; Davis
1977; Geurts 2000; NIH 2003; Tepperman 1984).
It is believed that pain is related to the biomechanical alteration of
the hemiplegic limb resulting in spasmodic or spastic muscles and
contracted joints (Davies 1991; NIH 2008; Zieve 2009; Zyluk
1999). The stability of the joint is considerably affected due to
paresis or palsy of the shoulder girdle muscles, which results in partial subluxation or dislocation of the humeral head (Davies 1991;
Zieve 2009; Zyluk 1999). Repeated microtraumas of the shoulder
joint may cause chronic pain and may initiate exacerbation of an
abnormal, regional sensory-sympathetic reflex arch (Davies 1991;
Zyluk 1999). Pain is thought to be a marker of stroke severity
(Roy 1995), as well as having a significant negative impact on the
functional recovery of the upper limb, as noted in various rehabilitation studies (Gowland 1982; Nakayama 1994; Wyller 1997).
The practice of acupuncture originated in China over 2000 years
ago (MP 2010; Wu 1996). It is a relatively simple and inexpensive
treatment compared with many other commonly used interventions (Wu 2006; Zhang 2005). Today, acupuncture is widely used
throughout the world and is one of the main pillars of traditional
Chinese medicine (NS 2007). It has been used by Chinese doctors
to improve motor, speech and other functions after stroke (Wu
2006; Zhang 2005). Acupuncture, considered a new, alternative

Description of the intervention

Pain medication often provides some reduction in pain, but no
single drug or combination of drugs gives long-lasting pain relief (AAFP; Geurts 2000; NIH 2008). Analgesic drugs and corticosteroids can help (AAFP; NIH 2003; NIH 2008) and tricyclic antidepressants such as nortriptyline, or anticonvulsants
such as neurontin (gabapentin), can be useful (Geurts 2000; NIH
2003). Some drugs that relieve patients tension help to reduce
pain (AAFP; Geurts 2000; NIH 2003; NIH 2008). Unfortunately,
most medications provide little relief from these sensations, and
very few treatments or therapies exist to combat pain (NIH 2004;
Zyluk 2006). Early treatment to prevent pain worsening should
be considered (AAFP; NIH 2003; Roy 1994; Zyluk 1999). Many
treatments have been developed for upper limb pain, such as physiotherapy, massage, alternate emersion in cold and warm water,
traditional herb treatments (especially in the Orient), corrective
positioning of the limbs and trunk, compressive centripetal wrapping, active or passive movement, and electrical stimulation on
trigger points (Bender 2001; Chen 2007; Hanger 2000; Hao 2007;
Li 2004; Liao 2008; Yang 2008; Zhang 2008). Acupuncture is
also often used to treat and prevent pain. This review will assess
the efficacy and possible adverse effects of different acupuncture
therapies.

How the intervention might work

Acupuncture is thought to confer an analgesic effect (Batra 1985;
Green 2005; Viola 1998). Several hypotheses have been proposed
about the mechanisms of acupuncture on pain relief (Furlan 2005;
Green 2005). One of the most popular theories is the Gate Control
Theory (Furlan 2005; Singer 2006). According to this theory, the
perception of pain is controlled by a part of the nervous system
which regulates the impulse, which will later be interpreted as pain.
This part of the nervous system is called the gate. If the gate
is hit with too many impulses, it becomes overwhelmed, and it
closes (Singer 2006). The gate that controls the perception of pain
closes during acupuncture. Some authors attribute analgesic effects
to the release of endorphins, acetylcholine, 5-hydroxytryptophan
and noradrenaline within the central nervous system (Chu 1979;
Singer 2006; Stux 2003; Viola 1998). According to traditional
Chinese medicine, acupuncture can remove blockages in the flow
of qi (vital energy) through the stimulation of specific points on
the body (NCCAM 2007; Singer 2006; Viola 1998). In simple
terms, this is achieved via the insertion of very fine needles into a
persons skin at specific points, which is thought to influence the
physiological functioning of the body (MP 2010; NCCAM 2007;
Singer 2006).

Acupuncture for post-stroke upper limb pain (Protocol)

Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Why it is important to do this review

Types of interventions

Acupuncture is one of the key components of traditional Chinese

medicine and is increasingly practiced in some Western countries
(Johansson 1993; NIH 1998; Wu 2006). It is frequently used in
post-stroke patients to relieve upper limb pain. However, few studies have investigated the efficacy of this intervention. As far as we
know, no article has systematically reviewed trials on acupuncture
for the relief of pain for post-stroke patients. This review aims to
investigate the efficacy and safety of acupuncture for post-stroke
upper limb pain.

We will consider trials comparing any type of acupuncture therapy with placebo or no intervention, but all other standard care
should be the same and represent the best care available. We will
exclude studies of acupuncture plus another active therapy versus
the same active therapy. We will also exclude studies that compare
different types of acupuncture. Acupuncture therapy will be defined as body acupuncture, scalp acupuncture, electro-acupuncture, or warm needling, but not ear acupuncture. We will also
exclude acupuncture therapy combined with medication. If sham
(placebo) acupuncture is used, this will be defined as the needling
of non-acupuncture points without needle manipulation, done either proximally or distally, or both, to the true acupuncture point.

OBJECTIVES

Types of outcome measures

To assess the efficacy and possible adverse effects of acupuncture

for the treatment of post-stroke upper limb pain.

Primary outcomes

METHODS

Criteria for considering studies for this review

Upper limb pain intensity analysed as continuous variables and

measured using appropriate visual analogue scales.
When the primary outcome data are not reported as continuous
variables we will: 1) contact the study authors; 2) manage the data
as continuous variables and pool them; or 3) carry out option 2
and then use the Chinn approach (Chinn 2000) to convert the
continuous effect size into an odds ratio (OR) and standard error
(SE) to use in inverse variance meta-analyses.
Secondary outcomes

Types of studies
Randomised controlled trials investigating acupuncture for poststroke upper limb pain will be eligible for inclusion, regardless
of language and publication type. We will include studies that
compare acupuncture with placebo/sham acupuncture or no intervention. For randomised crossover studies, we will only include
the first phase of treatment. We will exclude confounded trials in
which the treatment or control group received another active therapy (e.g. acupuncture versus another intervention or acupuncture
plus another intervention versus control).

Types of participants
Participants of any age, gender or ethnicity with a diagnosis of
stroke according to accepted criteria and then suffering upper limb
pain will be eligible for inclusion. The diagnosis of upper limb
pain will be based on symptomatology. We will exclude studies
where acupuncture is provided with the aim of preventing pain in
a population who may not all have pain. Participants living in their
own homes or in residential care settings and accessed through
hospital inpatient or outpatient departments will be eligible for
inclusion.

1. Range of motion of the shoulder (including active or

passive, or both; flexion; extension; abduction; external rotation;
internal rotation; and hand behind back) - analysed as
continuous variables: degrees of shoulder range of motion.
2. Upper limb motor function - analysed as continuous
variables: numerical value on the Fugl-Meyer scale of upper limb
motorial function, Barthel Index, quality of life and other scales
for functional ability in activities of daily living.
3. Glenohumeral subluxation - analysed as dichotomous
variables: presence or absence of subluxation.
4. Anxiety or depression - analysed as dichotomous variables.
When the study outcomes are not reported as dichotomous
variables (e.g. anxiety - yes or no? or depression - yes or no?), we
will convert them as per the primary outcome.
5. Adverse events (including fainting, bleeding, petechiae,
haematoma, infection or death) - analysed as dichotomous
variables: presence or absence of adverse events.

Search methods for identification of studies

See the Specialized register section in the Cochrane Stroke Group
module.

Acupuncture for post-stroke upper limb pain (Protocol)

Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Electronic searches
We will search the Cochrane Stroke Group Trials Register, the
Cochrane Central Register of Controlled Trials (CENTRAL) (The
Cochrane Library, latest issue), the Chinese Stroke Trials Register,
the Chinese Cochrane Centre Controlled Trials Register, the Chinese Acupuncture Trials Register, MEDLINE (1950 to present)
(Appendix 1), EMBASE (1980 to present), CINAHL (1982 to
present) and ACUBRIEFS (http://www.acubriefs.com/). We will
also search the following Chinese databases: CBM (Chinese Biological Medicine Database), CNKI (Chinese National Knowledge
Infrastructure), CMCC (Chinese Medical Current Contents), Vip
database (Chinese Science and Technology Periodical Database),
WHO International Clinical Trials Registry Platform (ICTRP) (
http://apps.who.int/trialsearch/).
We will develop separate search strategies for each database in
consultation with the Cochrane Stroke Group Trials Search Coordinator.

and Chinese.

Data collection and analysis

Selection of studies
Two review authors (Liang and Peng), working independently, will
select studies for inclusion and extract data. We will screen all the
references from the database searches based on title and abstract.
We will exclude those that are definitely not relevant. We will
then obtain the full text of articles for those references that may
be relevant, and the same two review authors will select trials for
inclusion. The two review authors will resolve any disagreements
by discussion, with reference to a third review author (Ma) if
necessary. We will list excluded studies and provide reasons for
their exclusion.

Searching other resources

Data extraction and management

In an effort to identify further published, unpublished and ongoing trials we will undertake the following.
1. Handsearch the following Chinese journals from the date of
first publication (in an effort to avoid duplication of effort we
will not search issues already listed as searched on behalf of the
Cochrane Collaboration) (http://apps1.jhsph.edu/cochrane/
NSmasterlist.htm)
i) Chinese Acupuncture and Moxibustion (1981 to
present);
ii) Journal of Clinical Acupuncture and Moxibustion (1985
to present);
iii) Journal of Traditional Chinese Medicine (1960 to
present);
iv) New Journal of Traditional Chinese Medicine (1969 to
present);
v) Research of Acupuncture and Moxibustion (1976 to
present);
vi) Shanghai Journal of Acupuncture and Moxibustion
(1982 to present).
2. Identify and search relevant conference proceedings.
3. Search the following ongoing trials and research registers:
i) ClinicalTrials.gov (http://www.clinicaltrials.gov/);
ii) Current Controlled Trials (www.controlledtrials.com);
iii) Stroke Trials Registry (www.strokecenter.org/trials/).
4. Search reference lists of all relevant articles identified,
including reviews.
5. Contact authors of published trials and other researchers
working in the field.
6. Search Wanfang Data (www.wanfangdata.com).
We will search for trials in all languages and arrange for the translation of relevant articles published in languages other than English

The same two review authors (Liang and Peng) will independently
enter data onto a data extraction form. The third review author
(Ma) will resolve any discrepancies. We will obtain missing data
from trial authors when possible. Two review authors (Liang and
Peng) will check the data and enter them into Review Manager
(RevMan 2008).
Extracted data

We will extract data on any type of acupuncture therapy: body

acupuncture (comprising quick pricking and retaining needling),
scalp acupuncture (comprising quick pricking and retaining
needling), electro-acupuncture, and warm needling.
We will extract data about the time since stroke, regions of weakened or paralysed arms suffering pain, syndromes involving upper limb pain, periods of those syndromes, length or frequency of
treatment, and presence or absence of subluxation.
For binary data, we will seek the numbers in each treatment group
and the numbers experiencing the outcome of interest.
We will define the baseline assessment as the latest available assessment prior to randomisation, but no longer than two months
prior.
For each outcome measure, we will seek data on every patient randomised. To allow an intention-to-treat analysis, we will seek these
data irrespective of compliance and whether or not the patient
is subsequently deemed ineligible or is otherwise excluded from
treatment or follow-up. If intention-to-treat data are not available,
we will seek on-treatment data or data from those who completed the trial, and will indicate them as such.
In studies where a crossover design was used, we will consider data
from the first treatment phase after randomisation only eligible
for inclusion.

Acupuncture for post-stroke upper limb pain (Protocol)

Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Assessment of risk of bias in included studies

The quality assessment will include an evaluation of the following
components for each included study. We will categorise each component as adequate, unclear, or inadequate. The randomisation
criteria are as suggested by Juni 2001.
1. Randomisation (allocation generation) - adequate when the
allocation sequence protects against biased allocation to the
comparison groups.
2. Randomisation (allocation concealment) - adequate when
clinicians and participants are unaware of future allocations.
3. Masking (blinding of observers/participants to the
treatment allocation) - adequate when the outcome assessor is
unaware of the allocation.
4. Loss to follow-up - adequate when more than 80% of
participants are followed up and then analysed in the groups to
which they were originally randomised (intention-to-treat).
For selective outcome reporting, we will seek further information
from the study authors. We will then analyse the data again. If the
outcome is similar to the original outcome, we will include it and
assess it as one of the components. Otherwise we will exclude such
reporting.
We will give a description of the quality of each study based on a
summary of these components.

Measures of treatment effect

The outcomes measured in clinical trials of post-stroke upper limb
pain are often assessed using ordinal rating scales. Where the rating scales used in the trials have a reasonably large number of categories (more than 10) our intention is to treat data as continuous
outcomes arising from a normal distribution.
For crossover trials we will use only the data from the first treatment period. When final values are not reported, we will calculate
the required summary statistics from the baseline and assessment
time treatment group means and standard deviations. In this case
we will assume a zero correlation between the measurements at
baseline and assessment time. This method overestimates the standard deviation of the change from baseline, but this conservative
approach is considered to be preferable in a meta-analysis.
Meta-analysis requires the combination of data from trials that
may not use the same rating scale to assess an outcome. We will
measure the treatment difference for any outcome using the mean
difference (MD) when the pooled trials use the same rating scale
or test, and the standardised mean difference (SMD), which is the
absolute mean difference divided by the standard deviation, when
the trials use different rating scales or tests.
If there is significant heterogeneity we will not carry out a metaanalysis. Instead, we will perform a descriptive analysis to assess
the efficacy of acupuncture.
For binary outcomes, such as clinical improvement or no clinical
improvement, we will use ORs to measure the treatment effect. We
will calculate a weighted estimate of the typical treatment effect

across trials.

Unit of analysis issues

We will focus only on patient randomised studies and exclude
cluster randomised studies. We will make comparisons between
patients treated with acupuncture and controls on an intentionto-treat basis where possible. If possible, we will pool data from
different trials and calculate overall estimates of the treatment difference. We will use MDs, SMDs or ORs as appropriate.

Dealing with missing data

We will contact study authors for clarification or to request missing
data, if possible. If we cannot contact an author, we will estimate
the standard deviation of the pre-post treatment differences in the
treatment and control groups from the variances, as needed for
data analysis.

Assessment of heterogeneity
We will present overall estimates of the treatment difference. In all
cases we will present the overall estimate from a fixed-effect model,
and we will test for heterogeneity using the I2 statistic. If, however,
there is evidence of heterogeneity of the treatment effect between
trials then we will either pool only the homogeneous results or
we will use a random-effects model (in which case the confidence
intervals (CIs) will be broader than those of a fixed-effect model).

Assessment of reporting biases

We will investigate potential biases using the funnel plot or other
analytical methods according to Egger 1997.

Data synthesis
We will make overall comparisons between patients receiving
acupuncture and controls (receiving placebo/sham acupuncture or
no intervention). We will exclude other controls such as Western
medicine (both oral intake and external use), Chinese herbs (both
oral intake and external use), surgical operation, physiotherapy,
rehabilitation, etc. We will also exclude trials of acupuncture plus
other treatment versus the same treatment. We will calculate both
relative and absolute risk reductions for each dichotomous outcome. We will test for heterogeneity between trial results using a
standard Chi2 test. We will report the results as ORs with corresponding 95% CI for dichotomous data using the Peto fixedeffect method (APT 1994). For continuous data, we will compute
the MD for outcomes measured using the same scale, and we will
calculate the SMD when the same outcome (e.g. upper limb function) is measured using different scales.

Acupuncture for post-stroke upper limb pain (Protocol)

Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Subgroup analysis and investigation of heterogeneity

We will perform subgroup analyses where adequate information
is given. The subgroups analysed will be body acupuncture, scalp
acupuncture, electro-acupuncture, and warm needling. We will explore reasons for heterogeneity in studies and, if necessary, we will
use sensitivity analyses to examine the effects of excluding study
subgroups (e.g. those studies with lower methodological quality).
We will list non-randomised controlled studies but will not discuss
these further. We will describe studies relating to adverse effects
qualitatively.

Sensitivity analyses will assess the effect of:

including trials in which the review authors considered the
control condition or usual care to contain elements that may
provide an intentional or unintentional treatment effect;
blinding, dropouts and withdrawals.

ACKNOWLEDGEMENTS
We thank the Cochrane Stroke Group for their assistance in
preparing the protocol. We would also thank all those who provided information about their own or other trials.

Sensitivity analysis

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Acupuncture for post-stroke upper limb pain (Protocol)

Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Indicates the major publication for the study

APPENDICES

Appendix 1. MEDLINE search strategy

We will use the following strategy for MEDLINE (Ovid) and modify it to search the other databases.
1. cerebrovascular disorders/ or exp basal ganglia cerebrovascular disease/ or exp brain ischemia/ or exp carotid artery diseases/ or
exp cerebrovascular trauma/ or exp intracranial arterial diseases/ or exp intracranial arteriovenous malformations/ or exp intracranial
embolism and thrombosis/ or exp intracranial hemorrhages/ or stroke/ or exp brain infarction/ or vasospasm, intracranial/ or vertebral
artery dissection/
2. (stroke or poststroke or post-stroke or cerebrovasc$ or brain vasc$ or cerebral vasc$ or cva$ or apoplex$ or SAH).tw.
3. ((brain$ or cerebr$ or cerebell$ or intracran$ or intracerebral) adj5 (isch?emi$ or infarct$ or thrombo$ or emboli$ or occlus$)).tw.
4. ((brain$ or cerebr$ or cerebell$ or intracerebral or intracranial or subarachnoid) adj5 (haemorrhage$ or hemorrhage$ or haematoma$
or hematoma$ or bleed$)).tw.
5. hemiplegia/ or exp paresis/
6. (hemipleg$ or hemipar$ or paresis or paretic).tw.
7. 1 or 2 or 3 or 4 or 5 or 6
8. exp Upper Extremity/
9. (upper adj3 (limb$ or extremit$)).tw.
10. (arm or arms or shoulder$ or glenohumer$ or axilla$ or elbow$ or forearm$ or hand or hands or wrist$ or finger or fingers).tw.
11. shoulder pain/ or shoulder dislocation/ or reflex sympathetic dystrophy/
12. exp arm injuries/
13. elbow joint/ or exp hand joint/ or shoulder joint/
14. 8 or 9 or 10 or 11 or 12 or 13
15. acupuncture therapy/ or acupuncture analgesia/ or acupuncture, ear/ or electroacupuncture/ or meridians/ or acupuncture points/
16. acupuncture/
17. (acupuncture$ or electroacupuncture or electro-acupuncture or acupoint$ or needling).tw.
18. ((meridian or non-meridian or trigger) adj10 point$).tw.
19. (meridians or jing luo or jinglo or ching lo).tw.
20. 15 or 16 or 17 or 18 or 19
21. 7 and 14 and 20
22. limit 21 to humans

Acupuncture for post-stroke upper limb pain (Protocol)

Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

HISTORY
Protocol first published: Issue 4, 2011

CONTRIBUTIONS OF AUTHORS
Liang wrote the protocol, wrote and performed the literature searches; will screen the titles and abstracts; will apply inclusion criteria
and methodological quality assessments; will extract and analyse data and enter this into RevMan; will analyse and interpret data; will
write and enter text into RevMan.
Peng has assisted in the design of the protocol; will screen the titles and abstracts; will apply inclusion criteria and methodological
quality assessments; will extract and analyse data and enter this into RevMan; will provide critical comment on interim drafts of the
review.
Ma will apply inclusion criteria and methodological quality assessments; will extract and analyse data; will provide critical comment
on interim drafts of the review.

DECLARATIONS OF INTEREST
None known

Acupuncture for post-stroke upper limb pain (Protocol)

Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.