fibromylagia acupunture

8/18/2019 Fibromylagia Acupunture

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Background

Fibromyalgia (FM) is diagnosed when a patient has

pain in the axial skeleton, on both sides of the body

and above and below the waist for three months or

more, in combination with tenderness on pressure

of 11 out of 18 specific tender points – the American

College of Rheumatology (ACR) classification

c rite ria fro m 1 99 0.1 Fib ro my algia is a

polysymptomatic syndrome of chronic widespread

pain often accompanied by fatigue, non-restorative

sleep and visceral hyperalgesia. It is a common cause

of chronic widespread pain,2 responsible for an

estimated 10-20% of new patients attendingrheumatology clinics.3;4 T he s ymptoms o f

fibromyalgia can persist for many years and outcome

is generally poor.5-7 Chronic ill-health and disability

are well recognised consequences.8

Currently available treatments are often

ineffective. Amitriptyline has been shown to be

effective in some but not all patients with

fibromyalgia.9 Tramadol,10 either on its own or in

combination with paracetamol,11 has been shown to

be helpful in treating the pain of fibromyalgia. The

evidence for lidocaine infusions alleviating

fibromyalgia pain is equivocal.12 There is some

evidence that N-methyl-D-aspartate (NMDA)

antagonists, eg ketamine and dextromethorphan canameliorate the pain of fibromyalgia,13;14 and more

ACUPUNCTURE IN MEDICINE 2007;25(4):137-147.www.acupunctureinmedicine.org.uk/volindex.php 137

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Acupuncture in the treatment of fibromyalgia intertiary care – a case series Barbara Duncan, Adrian White, Anisur Rahman

Abstract

Aims Fibromyalgia is a common cause of chronic widespread pain. The benefit of medication is often

limited by its side effects, and the improvements obtained with exercise and education are inconsistent.

Many patients seek acupuncture treatment, which is reported to be helpful in some cases. This study aimed

to explore the acceptability and benefits of acupuncture offered in the setting of a tertiary referral clinic.

Methods An open, uncontrolled observational study was conducted among patients who met the usual

fibromyalgia criteria and who had a pain score of at least 30 on a 100mm Visual Analogue Scale (VAS).

Patients were allowed to continue other treatments but not to introduce new ones. Acupuncture was given using

a Western approach according to a protocol developed by consensus. Patients were offered eight treatments

in eight weeks. Outcome measures included VAS of pain intensity and Fibromyalgia Impact Questionnaire

(range 0 – 100), and were taken before and after treatment, and at 14, 20 and 34 weeks from enrolment.

Results Twenty four eligible patients were enrolled in a 12 month period. Baseline mean pain VAS score for

these 24 patients was 74 (SD 18) and mean Fibromyalgia Impact Questionnaire score 78 (SD 12.4). Only 14

patients completed the course of treatment within about 10 weeks. Compliance was poor in the remaining

patients because of difficulty attending clinic, and in two cases because of exacerbation of pain. Completion

of outcome measures was variable and therefore the analysis of data is limited. Five patients scored at least

20% reduction in Fibromyalgia Impact Questionnaire score which is a clinically relevant improvement. Two

of these scored at least 50% reduction.Conclusion Acupuncture appears to offer symptomatic improvement to some patients with fibromyalgia

in a tertiary clinic who have failed to respond to other treatments. In view of its safety, further acupuncture

research is justified in this population.

Keywords

Acupuncture, fibromyalgia, case series.

Barbara Duncan

consultant in

pain medicine

Pain Management

Centre

The National Hospital

for Neurology &

Neurosurgery

University College

London Hospitals

Adrian White

clinical research fellow

Primary Care Research

Peninsula Medical

School, Plymouth UK

Anisur Rahman

reader and honorary

consultant

in rheumatology

Centre for

Rheumatology

University CollegeLondon Hospitals

Correspondence:

Barbara Duncan

barbara.duncan

@uclh.nhs.uk


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recent evidence supports the use of pregabalin,

gabapentin and duloxetine.15 However, these

medications have side effects that can make them

intolerable to patients with fibromyalgia, who are

often more sensitive to medication.16;17 Education

and exercise have been shown to improve somesymptoms of fibromyalgia but results are

inconsistent.17-19 Their beneficial effects depend on

motivation and ability to comply with the exercise

regime.

Treatments that can minimise unpleasant

symptoms (without troublesome side effects) and

reduce the health and social burden of this disease

would be welcome. Acupuncture has the attraction of

not being a pharmacological product consumed on a

daily basis. Clinical observation suggests that

acupuncture may be a viable adjunct in the

management of fibromyalgia. Increased use of

acupuncture has been encouraged by the British

Medical Association, while calling for better quality

of evidence.20 However, there are limited resources

for acupuncture in the NHS and it is important to

use them efficiently, concentrating on conditions

where the potential for benefit is based on best

evidence.

One third of the patients with fibromyalgia

described by Ledingham had been treated with

acupuncture, and 29% of these had found it helpful.8

A recent review included five RCTs of acupuncture

in fibromyalgia,21 and concluded that the evidence

is mixed and that further rigorous studies seem

warranted. They also noted that all the positive trials

used electroacupuncture.

The first author currently uses manual

acupuncture (but not electroacupuncture) in this

tertiary specialist pain clinic to treat patients with

fibromyalgia. We originally planned to test the

effectiveness of manual acupuncture in an RCT, andtherefore designed a feasibility study to provide us

with information on which to base a subsequent grant

application, and gained consent of The National

Hospital for Neurology and Neurosurgery and

Institute for Neurology Joint Research Ethics

Committee. However, because of the difficulties we

experienced, which we describe here, it seems

unlikely that a definitive RCT would be funded in

this setting.

Therefore, our aim in this paper is to simply

report the patients’ progress. The fact that we

originally planned a pilot study explains certain

features which might have been different in a case

series, such as certain inclusion criteria, the restriction

on using other interventions for the whole of the six

months’ trial period, and the multiple outcome

measures we used. However, we wish to report ourfindings out of recognition of the patients’

commitment to the trial, and to add to the body of

evidence on what this type of acupuncture may

achieve for patients with advanced fibromyalgia,

and to provoke discussion on different treatment

approaches.

Methods

An open, uncontrolled observational study was

conducted among outpatients at the Centre for

Rheumatology, University College London and the

Pain Management Centre, University College

London.

Patients aged between 18 and 65 years with

fibromyalgia, as defined by the ACR criteria,1 were

recruited. Only patients who rated their pain level

as 30 or higher on a 100mm Visual Analogue Scale

(VAS) were included, as we judged this to be

sufficient to demonstrate a reduction. Presence of a

co-existing systemic rheumatological illness (such

as systemic lupus erythematosus or Sjogren’s

syndrome) was not an exclusion factor, since it has

been shown that this does not affect the clinical

characteristics of fibromyalgia.1

Patients with clotting disorders were excluded, as

were patients who had previously experienced

acupuncture for fibromyalgia and those who did not

wish to be given acupuncture.

All regular medications were continued during

the study period. Use of amitriptyline or any other

drug prescribed for fibromyalgia or musculoskeletal

pain was not an exclusion factor, provided the dosehad been stable for at least three months before

entering the trial.

Patients were excluded if they had started

physiotherapy, psychology or education sessions

within the last three months, and patients were asked

not to start these forms of therapy during the treatment

period or for a follow up period of three months.

We aimed to recruit and treat 24 patients, which

we calculated would be enough to identify a

statistically significant response, eg a 20% reduction

in pain intensity VAS (from 60 to 40).

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All patients presenting in clinic were assessed by

AR or BD to confirm that they met the ACR criteria

and the other inclusion criteria. They were then given

an information sheet which explained the need to

complete extra questionnaires and the possibility of

mild side effects including dizziness, drowsiness,headache, nausea, bruising and possible temporary

worsening of pain.22 Patients declining to give consent

were offered acupuncture in the usual way, outside

the study.

Acupuncture intervention

All procedures were carried out by BD, who has been

a member of the BMAS for six years and is a

consultant pain specialist experienced in the use of

acupuncture for treating fibromyalgia, at the Pain

Management Centre, National Hospital for Neurology

and Neurosurgery. Treatment was carried out

according to the usual practice there, ie using a

Westernised approach to acupuncture, involving

manual needling of trigger points, appropriate

neurosegments and distant sites, depending on the

locations of painful areas in the individual patient.

Superficial needling with a small number of needles

was used, because patients with fibromyalgia are

often especially sensitive to needling.23 Superficial

needling of the skin in people with fibromyalgia has

been shown to produce an increase in skin and muscle

blood flow not seen in healthy subjects.24 This

supports the concept that light needling of the skin in

fibromyalgia patients could produce the same effect

as deeper intramuscular needling in normal subjects.

The treatment protocol (see Appendix) was

designed to be reproducible but allow flexibility. It

was sent to six senior members of the British Medical

Acupuncture Society for review, and modified in

response to their comments; at least one commentator

thought the duration of needling was excessive.Electroacupuncture was not recommended by any

of the reviewers.

The protocol specified that patients would be

given eight treatments at weekly intervals. From

clinical experience with fibromyalgia patients,

improvement is commonly not seen until the fourth

or fifth treatment, and BD routinely offers a

maximum of 10 acupuncture treatments. Giving eight

treatments was regarded as a reasonable compromise

between the minimum necessary and the maximum

possible within the limited resources of the Centre.

At each appointment, patients were asked about the

response to the previous treatment, and the sites and

severity of pain were established in order to plan

further treatment.

Outcome measuresOutcome measures were collected on five occasions

– immediately before treatment, at the end of the

eight week treatment; then by post after six weeks (14

weeks from randomisation) and three months (total

20 weeks); and finally at a clinic visit after six months

(total 34 weeks after enrolment).

Outcome measures included the following: 1)

VAS of pain intensity at that moment in time; 2) the

Fibromyalgia Impact Questionnaire (FIQ), a validated

20 item questionnaire which includes questions about

work, ability to carry out everyday activities,

tiredness, pain, stiffness and depression;25 with higher

scores indicating greater impairment; 3) the Short-

Form McGill Pain Questionnaire; 4) the Pain Self-

Efficacy Questionnaire, where patients are asked to

rate their confidence in performing various activities;

5) the SF-36 (Short Form 36 Health Survey), in nine

domains exploring physical, psychological and social

aspects of the patient’s response, from which we

analysed the physical and mental components; 6)

the Hospital Anxiety and Depression scale; 7) a

global assessment of change: ‘Please tick the box to

show how you think your fibromyalgia is now,

compared with before acupuncture’, offering a choice

of five responses from ‘very much better’ to ‘very

much worse’.

Analysis

The analysis was exploratory. Where data were

missing for one or two time points, but present for a

subsequent one, the value of the last reading was

carried forward. Data were not carried forward formore than two missing time points, nor after patients

had dropped out.

It was not possible to give some patients weekly

treatments because they attended so sporadically.

Since a continuous course of treatment may be

necessary for acupuncture to be effective, we decided,

when looking at the results, to group patients and

analyse results according to whether they had

complied with regular appointments and received

an appropriate course of acupuncture. Patients were

placed into three groups. Group 1 included patients


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who completed the treatment protocol in or close to

eight weeks. Group 2 included patients whose

treatment was spread over time with intervals of

several weeks between treatments, for reasons

relating to poor health or social circumstance. Patients

who failed to complete treatment were placed ingroup 3 and not included in the main analysis.

Results

A total of 25 patients were enrolled between

November 2003 and November 2004. One patient

was subsequently excluded as her initial VAS score

was too low, leaving 24 patients for analysis. Figure

1 shows their flow through the study. Baseline pain

VAS score for these 24 patients was 74 (SD 18) and

FIQ score 78 (SD 12.4).

Group 1 contained 14 patients, and Group 2 had 6

patients. Reasons for failing to attend treatment

regularly included disability from fibromyalgia and

hospitalisation for severe depression. Four patients

(Group 3) failed to complete the treatment protocol.

Two of these experienced more severe pain followingacupuncture despite very light needling.

In many cases there were considerable amounts

of missing data. Nine patients had data missing at

follow up of either 20 or 34 weeks, or both. There

was a notably poor return of postal questionnaires.

One patient who completed treatment per protocol

did not complete any measures in a manner that could

be used, and on the follow up visit her daughter was

seen to be completing the VAS score. On two

occasions, FIQ was not completed when other


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Figure 1 This chart shows the flow of patients through treatment and follow up.


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questionnaires were. Thus, of the 24 patients eligiblefor inclusion, 14 (60%) completed the treatment as

per protocol but only five of these (20% of those

enrolled) provided sufficient data for a complete

evaluation.

The socio-demographic and outcome data for

the three groups are presented in Table 1. Group 1

tended to be older than groups 2 and 3 and to take

more medication for other medical conditions. There

were no other meaningful differences between the

groups All three groups had a median of two other

significant medical conditions.

Global scores were reported by four patients on atleast one occasion as ‘very much better’, all in

Group 1. Only one patient still scored ‘very much

better’ at 34 weeks, and this self assessment is

consistent with her scores for other measures: for

example, her FIQ fell from 60.5 to 20.6, and VAS

7.1 to 0.3.

The FIQ is regarded as the most valid measure of

overall impact of fibromyalgia, and individual scores

of patients in Group 1 are shown in Figure 2. At the

end of treatment three scored at least 20% reduction

and two others at least 50% reduction. One patient


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Table 1 Baseline data of three groups of patients

previousage, y baseline baseline FIQ ethnic number of duration of

acupunctureVAS, mm origin drugs taken symptoms, y

(helped), n

Group 1 white = 6

(per protocol) 53.0 (12.9) 74 (17) 75.3(11.6) black = 4 4.4 (1.5) 7.1 (5.8) 6 (2)

n=14 Asian = 2

other = 2

Group 2

(significant delays) 45.3 (11.5) 74 (13) 77.3 (10.5) white = 4

3.5 (1.6) 6.3 (3.4) 2 (1)

n=6 other = 2

Group 3 white = 2

(inco mplete treatment) 3 5.6 (16 .6) 72 (30 ) 86 .7 (16. 7) black = 1 2.3( 1.3) 7.5 (3. 3) 1 (0 )

n=4 other = 1

Values are means (SD) except where indicated

Abbreviations: FIQ – Fibromyalgia Impact Questionnaire; y – years; n – number

Figure 2 Individual Fibromyalgia Impact Questionnaire scores are shown of the 13 patients in Group 1 who provided data.


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still had 20% improvement at six months, and one

still had greater than 50% reduction. The respondents

were not different from non-respondents in either

mean age (54 and 52 years respectively) or duration

of symptoms (six and eight years respectively).

Because of the amount of data that remained

missing, even after substituting as described above,

group analyses can be considered reliable only for 11

patients at four weeks in Group 1, and only for five

patients at three weeks in Group 2. There was a small

but consistent reduction in group scores for all

measures at the end of treatment in Group 1, ie the

patients who received acupuncture as per protocol.This is shown for three outcomes in Table 2. No

reduction was seen in any measure in Group 2. There

was no suggestion of a continued effect in Group 1,

as group scores for all measures returned to baseline

values from week 14 onwards.An analysis of those

eight patients who provided baseline and six month

data showed no trend to any long term effect.

Finally, for the remaining outcomes, results are

presented from all patients who provided data up to

the fourth data point (20 weeks), and are shown in

Table 3.

Discussion

In this group of 24 patients with fibromyalgia referred

to a tertiary pain clinic and willing to receive

acupuncture in the context of a trial, acupuncture is

of limited application mainly because repeated

attendance at clinic can be a problem. In retrospect,

the severity of the symptoms, using these outcome

measures, would not have predicted difficulty with

attendance. It may be more relevant that these people

were living alone and did not have anyone to

accompany or take them to clinic. Patients with

fibromyalgia often complain about deterioration of

cognitive function. Park and colleagues demonstrateddeterioration of short term memory and deficits in

vocabulary comparable to aging by 20 years.26 This

may be relevant in attending outpatient appointments

eg one patient described leaving home and not being

able to remember where she was going – arriving

for her appointment was a major achievement.

Of the 14 patients who could attend for the course

of treatment, about a third had measurable benefit

of at least 20% reduction in the FIQ score, which is

a clinically relevant improvement. Two of these

patients had a greater than 50% improvement.


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Table 2 Mean scores (SD) for three main outcomes at different time points

FIQ VAS McGill total

group 1 group 2 group 1 group 2 group 1 group 2

week 0 78.1 (11.5) 75.7 (11.0) 76 (17) 7.4 (1.4) 33.0 (7.7) 26.0 (10.5)

week 8 69.0 (8.7) 74.8 (4.7) 55 (24) 6.3 (2.7) 27.3 (9.1) 26.4 (7.5)

week 14 67.3 (23.8) 76.2 (10.0) 67 (26) 7.4 (0.9) 25.8 (8.1) 29.4 (4.3)

week 20 65.7 (16.9) insuff 73 (122) insuff 29.3 (9.7) insuff

week 34 68.2 (25.6) 61 (29) 31.9 (6.4)

Group 1 (n=12 up to week 14; n=9 at week 34) and group 2 (n=5)

Abbreviations: FIQ – Fibromyalgia Impact Questionnaire; VAS – Visual Analogue Scale of Pain Intensity; McGill – Short-Form McGill

Pain Questionnaire; insuff – insufficient

Table 3 Scores for other outcomes

HAD-A HAD-D SF-36 physical SF-36 mental PSEQ

week 0 15.3 (3.5) 13.1 (4.2) 26.4 (6.1) 28.8 (6.5) 17.0 (13.2)

week 8 14.4 (3.5) 10.6 (5.0) 28.8 (3.5) 33.9 (7.9) 18.9 (14.6)

week 14 13.7 (5.1) 11.9 (4.8) 29.2 (7.5) 31.2 (10.9) 21.6 (17.7)

week 20 13.9 (4.8) 12.9 (4.4) 26.9 (8.4) 32.6 (9.0) 20.6 (16.7)

All patients who provided sufficient data, combined (n=15)

Abbreviations: HAD-A – Hospital Anxiety and Depression Scale – Anxiety component; HAD-D – Hospital Anxiety and Depression

Scale – Depression component; SF-36 physical – physical component of the SF-36 Health Survey; SF-36 mental – mental component

of the SF-36 Health Survey; PSEQ – Pain Self-Efficacy Questionnaire


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However, our data do not provide any information on

which patients respond best. We have no evidence

that the likelihood that a patient will respond can be

predicted from their age, severity or duration of

symptoms. The one patient who was excluded,

because her VAS score was below 30, showedmarked improvement in other outcome measures.

The presence of multiple pathology or use of other

medications did not seem to prevent a response to

acupuncture (though we cannot say whether or not

these factors reduce the size of the response).

Because we had no control group, we cannot

draw any conclusions as to whether this response in

some patients is a specific effect of needling.

Acupuncture protocol

A protocol for application of acupuncture was used

to allow reproducibility of method. In practice some

changes were necessary during the study. The overall

number of needles allowed should be greater than

10. The number was limited to 10 needles for this

study to minimise the cost of placebo needles for a

future RCT. Towards the end of the study, the

protocol was modified to try to improve the response,

and two patients had more than 10 of the smaller

needles inserted – with benefit. It is possible that

limiting the number of needles impaired the response

to treatment. The use of electroacupuncture is

discussed below.

There is a wide spectrum of sensitivity to

acupuncture in fibromyalgia. Some people respond

to light superficial needling with a severe

exacerbation of pain, whereas others improve with 20

deep needles inserted intramuscularly, as was evident

in this study. Currently, it is not possible to predict

which people will require deep needling to produce

a good response. Lundeberg and Lund’s recent article

provides the neurophysiological basis for suggestingan approach that tries both ‘light’ and ‘strong’

stimulation when performing acupuncture for patients

with fibromyalgia, continuing with the more

successful one.27 Three out of 25 patients had the

larger (0.3mm diameter) needles inserted, contrary to

the recommendation of Baldry,28,29 with good effect.

The protocol also defined manual stimulation as

rotation of the needles for five seconds every minute,

which was difficult to reproduce precisely.

A number of patients initially responded well to

a gradual increase in the number of tender points

needled, but reached an upper limit, above which

the pain became worse. They were therefore treated

with distal points instead, including LI4, LR3, ST36

and SP6. Their response often improved with this

approach, which was partially catered for in the

protocol by allowing additional traditional points.The treatment protocol had not anticipated omitting

tender point needling.

Other studies of acupuncture for fibromyalgia

Four RCTs in the Western literature provide findings

that can be compared with our own. In three of these

studies, the patients were clearly less severely affected

than ours. Harris and colleagues explored three

treatment variables – needling sites, needle

stimulation, and dose of treatment – for pain in a

crossover study in 114 patients recruited through the

media, with average baseline VAS of about 55. They

found only an overall dose effect of manual

acupuncture. 30 Deluze and colleagues, in patients

recruited after referral to a rehabilitation clinic with

baseline VAS of about 60, found electroacupuncture

significantly more effective than a minimally active

control treatment, for several outcome variables.31

Martin and colleagues compared acupuncture with a

non-penetrating sham acupuncture in a rigorous RCT

in 50 patients with fibromyalgia; the acupuncture

group showed significantly greater improvement in

symptoms measured by the Fibromyalgia Impact

Questionnaire, particularly fatigue and anxiety.32 The

benefits were still present, though reduced, after seven

months. Baseline FIQ scores of around 43 indicate

that the patients were less severely affected than ours.

In another study, Assefi and colleagues recruited

patients through media and healthcare providers,

with a mean pain intensity VAS score of 7 on a 10cm

scale.33 A course of 12 sessions of a specific manual

acupuncture prescription in 100 patients was no betterat reducing pain than the pooled results from three

control interventions: acupuncture for a different

condition; non-point acupuncture; and a non-

penetrating control. There were trends towards

differences between the control interventions, but

these were not commented on by the authors. The

trial was no doubt under powered to show a

difference between a specific form of needling, and

a combination of other varieties of needling.

Only one of the reports of these studies gives an

estimate of the percentage of responders (as well as


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group mean scores). Deluze reported that about half

his patients in the acupuncture group ‘improved

satisfactorily’, a quarter showed no change, and a

quarter showed ‘an unexpectedly large improvement’.

Like us, these authors could not find any different

features that marked out good responders.

Implications for research

This study recruited a group of patients who are, by

definition, difficult to treat: they had not responded

to other treatments and were referred to a tertiary

pain clinic where, as a last resort, they are offered

acupuncture. The severity of their symptoms at

baseline (mean pain VAS score 74, mean FIQ score

78) confirms this. Our results suggest that manual

acupuncture could be helpful to some of these

patients and further research is justified.

Two problems have not been resolved: it is not

easy to predict which patients will be able to attend

for the whole course of acupuncture within the

allotted time period, and it is currently impossible

to target the treatment at the patients who are most

likely to respond. However, we believe this research

may be worth pursuing because acupuncture seems

to offer a useful therapy to some patients, and is

relatively free of side effects apart from temporary

exacerbations of pain. There is considerable interest

and investment in pharmaceutical research

(pregabalin, milnacipran, duloxetine etc), even though

medications have to be taken continuously and

usually cause problematic side effects in this group

of patients.

Interestingly, the sample size for a definitive

study may not need to be prohibitively large in similar

populations, because there seems little variance in

the scores for FIQ, the recommended primary

outcome measure. The baseline standard deviation

was much less than a quarter of the mean baselinescore in this study, and other studies in secondary

care have similar findings.32;34 Using our data, a

difference between groups of 8 points (10% of

baseline) would be identified with a total sample of

80 patients analysed. Martin calculated he needed a

total sample of 50 to identify a 2 point difference in

the FIQ scale.32

An RCT would be feasible in the patients who

attend this tertiary referral centre, but would have to

be limited to only those who are likely to be able to

attend repeatedly. Recruitment of 50 patients would

take about two years. It seems likely that delivering

the acupuncture treatment in primary care, close to

the patient, might increase recruitment and attendance

for follow-up. Modifications to our study protocol

that we would suggest include: allowing patients

who do not respond to drop out before the sixmonths’ follow up period, so they can try other

treatments; and being more rigorous at ensuring that

patients do not start other treatments at the advice

of their GP. One patient had a course of physiotherapy

for shoulder pain, and another took advantage of free

aromatherapy massage. Future studies could also

investigate the long-term outcome of offering

continued, intermittent treatment to responders, in

order to maintain their improvement. Finally,

electroacupuncture should be considered for future

studies since it was used in both positive trials

reviewed.31;32

Outcome measures

This study included an excessive number of outcome

measures (for reasons explained above). This proved

a particular problem despite interpreters being

available as many patients did not speak English as

their first language. In a rigorous study, professional

qualified interpreters are permitted but not family.

Simple, quick outcome measures completed in clinic

would improve future data collection.

No measure seemed to be more sensitive to

change than FIQ in this study, so we would

recommend the FIQ because it is widely accepted.

Lundeberg and Lund35 comment on sleep disorder

in fibromyalgia and draw attention to the failure of

acupuncture studies to measure quality of sleep

because pain is frequently the primary outcome

measure. FIQ contains one question related to sleep

so does include change of this parameter within an

overall assessment. Understanding and completionrate for postal questionnaires were not as good as

for questionnaires administered personally at the

time of the appointment. The outcome measures used

here only allowed for scoring of pain in the body as

a whole. When treating widespread pain there may be

– as there was in this study – improvement in pain in

one region, which was not reflected in the results.

For example, two patients remarked that their back

pain had improved considerably which made a

difference to their mobility but this was not always

reflected in the outcome measures.


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The number of measures needs to be reduced in

further studies. SF-36 is long, and has no advantage

over FIQ. Since this study was designed, a new tool

to measure mood in pain patients has been developed

– Depression Anxiety and Positive Outlook Scale

(DAPOS) which would be useful in future studies.36

Mood disorders are known to impair recovery.37 The

one patient who maintained the improvement

particularly well had a positive outlook. This patient

was still in active employment, which is known to

reduce the impact of pain related disability. For future

studies we would recommend VAS, FIQ, and

DAPOS.

Conclusion

Acupuncture may have a role as treatment for some

patients with fibromyalgia that has been unresponsive

to other therapies, but the response is unpredictable.

Further research into acupuncture is indicated because

of its lack of serious side effects. Comparisons

between manual and electroacupuncture should be

conducted, to determine which produces better

results. Suggestions have been made for the design of

such studies, including the optimal outcome

measures.

Conflicts of interest

BD, AR none declared. AW is employed by the

British Medical Acupuncture Society.

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7. Wolfe F, Anderson J, Harkness D, Bennett RM, Caro XJ,

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Papers

Summary points

Fibromyalgia (FM) is a common cause of chronic

widespread pain

The benefit of medication in FM is often limited by its side

effects

Acupuncture appears to offer symptomatic improvement to

some patients with FM in a tertiary clinic

In view of its safety, further acupuncture research is

justified in this p opulation

Comparisons between manual and electroacupuncture should

be conducted, to determine which produces better results


10/11

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efficacy, safety and practice. Amsterdam: Harwood

Academic Publishers; 2000.

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systematic review of randomized clinical trials.

Rheumatology (Oxford) 2007;46(5):801-4.

22. White A, Hayhoe S, Hart A, Ernst E; BMAS and AACP.

British Medical Acupuncture Society and Acupuncture

Association of Chartered Physiotherapists. Survey of adverse

events following acupuncture (SAFA): a prospective study

of 32,000 consultations. Acupunct Med 2001;19(2):84-92.

23. Camp AV. Acupuncture for Rheumatology Problems. In

Filshie J, White A, editors. Medical Acupuncture: a Western

Scientific Approach. Edinburgh: Churchill Livingstone; 1998.

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needle stimulation (acupuncture) on skin and muscle blood

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impact questionnaire: development and validation.

J Rheumatol 1991;18(5):728-33.

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2001;44(9):2125-33.

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acupuncture procedures in fibromyalgia syndrome (FMS)

valid? Acupunct Med 2007;25(3):100-6.

28. Baldry PE. Acupuncture, Trigger Points and Musculoskeletal

Pain. Edinburgh: Elsevier Ltd; 2005.

29. Baldry PE. Large tender areas, not discrete points, observed

in patients with fibromyalgia. Acupunct Med 2007;

25(4):203.

30. Harris RE, Tian X, Williams DA, Tian TX, Cupps TR, Petzke

F et al. Treatment of fibromyalgia with formula acupuncture:

investigation of needle placement, needle stimulation, and

treatment frequency. J Altern Complement Med

2005;11(4):663-71.

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Electroacupuncture in fibromyalgia: results of a controlled

trial. BMJ 1992;305(6864):1249-52.

32. Martin DP, Sletten CD, Williams BA, Berger IH.

Improvement in fibromyalgia symptoms with acupuncture:

results of a randomized controlled trial. Mayo Clin Proc

2006;81(6):749-57.

33. Assefi NP, Sherman KJ, Jacobsen C, Goldberg J, Smith

WR, Buchwald D.A randomized clinical trial of acupuncture

compared with sham acupuncture in fibromyalgia. Ann

Intern Med 2005;143(1):10-9.

34. Richards SC, Scott DL. Prescribed exercise in people with

fibromyalgia: parallel group randomised controlled trial.

BMJ 2002;325(7357):185.

35. Lundeberg T, Lund I. Did ‘The Princess on the Pea’ suffer

from fibromyalgia syndrome? The influence on sleep and

effects of acupuncture. Acupunct Med 2007;25(4):

184-97.

36. Pincus T, Williams AC, Vogel S, Field A. The development

and testing of the depression, anxiety, and positive outlook

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p. 33-46.

Editorial handling

In view of the second author’s conflict of interest as

Editor of this journal, all editorial handling of, and

decisions about, this article were carried out

independently by Mike Cummings on behalf of theeditorial board.


Papers


11/11

Treatment protocol

At the first treatment, two or three of the patient’s

most painful areas will be identified, tender points

located, and a maximum of six (more usually four)

fine needles (0.2mm x 15mm Seirin B type needle)

will be inserted subcutaneously in the points that are

the most tender and left in situ for three minutes.

At subsequent sessions the treatment will be

modified in light of the patient’s response: further

schedules depend on whether the pain is worse after

the first treatment. Treatment is to be given weeklyfor eight sessions.

1. Schedule for patients whose pain was not

aggravated by the first treatment – see

Appendix Table 1

Those who failed to respond will receive stepwise

increase in stimulation, involving thicker needles

(0.3mm x 30mm Seirin B type needle) and more

needles (maximum of 10) inserted intramuscularly.

The needles will be left in situ for a longerperiod of time

(to a maximum of 10 minutes) andmanually stimulated,

ie rotated in both directions for 5 seconds every minute.

Treatment 2: standard (0.3mm x 30mm Seirin B

type needle) needles inserted intramuscularly, same

number and duration as before. Treatment 3: more

needles left in situ for the same period of time with

manual stimulation. Treatment 4: increase the number

of needles to the maximum, duration to 5 minutes.

Treatment 5 to 8: increase duration to the maximum.

In general, once the patient responds positively

and the pain is improving, the acupuncture in that

area will not be increased. If the patient’s pain is

worse following any treatment session then needling

will be reduced to the previous dose.

In addition, points on hands for upper limb and

neck pain (LI4) and points on the feet (LR3) for

lower limb pain may be used. Other points that may

be used are LI11, ST36, SP6, KI3, if they are close tothe painful area being treated or are tender.

2. Schedule for patients whose pain is aggravated

by the first treatment – see Appendix Table 2

For those patients who responded with aggravation

of their pain, the treatment schedule will be as

follows. Treatment 2: using the same size needle as

in the first treatment, needle the most painful tender

point in one painful area subcutaneously for 1 minute,

without stimulation. If even this causes aggravation

of the pain without any subsequent improvement

then acupuncture is abandoned.

If there is no change in pain following the second

treatment, eitherthe numberof needles can be increased

by one, or the duration increased by one minute at

each treatment, continuing to use fine needles. Both

parameters are not increased at the same time.


Papers

Appendix

Appendix Table 1 Acupuncture dose schedule for patients whose pain was not aggravated by the first treatment

Treatment Size of needle,Depth of needle

Number of Manual Time left in situ,

number mm needles stimulation minutes

1 0.2 x 15 subcutaneous 3-6 No 3

2 0.3 x 30 intramuscular 3-6 No 3

3 0.3 x 30 intramuscular 3-10 Yes 3

4 0.3 x 30 intramuscular max 10 Yes 5

5 0.3 x 30 intramuscular max 10 Yes 5-10

6 to 8 As 5

Appendix Table 2 Acupuncture dose schedule for patients whose pain was aggravated by the first treatment

Treatment Size of needle,Depth of needle

Number of Manual Time left in situ,

number mm needles stimulation minutes

1 0.2 x 15mm Subcutaneous 3-6 No 3 min

2 0.2 x 30mm Subcutaneous 1 No 1 min

3 0.2 x 30mm Subcutaneous 2 No 1 min4-8 0.2 x 30mm Subcutaneous 2-10 No 1 min

fibromylagia acupunture

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