Case series investigating the experience of pain in patients with chronic venous leg
ulcers treated with a foam dressing releasing ibuprofen
Madeleine Flanagan
MA, BSc (Hons), Dip N (Lon), Cert Ed (HE), RGN
Principal Lecturer Tissue Viability
Post Registration Nursing
Faculty of Health and Human Sciences
University of Hertfordshire, Hatfield, Hertfordshire
Email: [email protected]
Hanne Vogensen
Project Research Nurse
Bispebjerg Hospital, Copenhagen, Denmark
Lone Haase
Project Research Nurse
Bispebjerg Hospital, Copenhagen, Denmark
Keywords: chronic venous leg ulcers; pain; foam dressing releasing ibuprofen;
health-related quality of life.
Key Points
1. Changes in wound pain intensity, relative ulcer area and health-related quality
of life were studied in 10 patients with chronic venous leg ulcers treated with a
foam dressing releasing ibuprofen and compression bandaging.
2. A common experience of unrelenting, persistent wound pain and intermittent
bursts of intense, spontaneous pain were discovered. Key themes identified
were the unpredictability and unrelenting nature of the ulcer pain and the
challenge of living with fatigue and restrictions on activities.
3. The findings demonstrate that persistent wound pain fluctuates over a 24-hour
period and can be difficult to control.
4. Nine out of ten patients in this case series reported overall pain reduction and
improved mobility, sleep and mood during the study.
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Heading 1
This prospective case series examined ten patients with painful chronic venous leg
ulcers who were treated for six dressing changes with a foam dressing releasing
ibuprofen (Biatain-Ibu) and appropriate compression bandaging. The aim of the case
series was to profile the characteristics and experience of these individuals. Endpoints
of the study were change in wound pain intensity, relative ulcer area and healthrelated quality of life. The findings demonstrated that these patients experienced
persistent, severe wound pain with intermittent bursts of intense spontaneous pain.
Nine out of ten patients reported overall pain reduction, improved mobility, sleep and
mood during the study. Pain intensity scores decreased during the study but
increased one week after discontinuing treatment.
Heading 1
Background to study
Over the past 15 years numerous studies have provided evidence that people with
chronic venous leg ulcers (CVLU) have a reduced health-related quality of life
(HRQoL). Effects on the quality of life of this client group have been investigated using
both generic and disease-specific assessment tools [1] [2] and qualitative approaches
that describe the patient’s experience [3].
The negative effect on HRQoL in leg ulcer patients is caused by many inter-related
factors including wound odour, exudate leakage, skin problems, pain, restricted
mobility, lack of sleep and increased frequency of dressing and bandage changes [2]
[4] [5]. For those with non-healing ulcers this may lead to loss of independence, lack
of energy, mood changes and social isolation [6]. For some this may result in
depression, loss of self-esteem, anger and high levels of anxiety [7] [8].
Wound pain is consistently reported by patients as the most prominent feature of
CVLU [2] [4] [5] [9]. The prevalence of pain in CVLU has been reported to be as high
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as 64% [10]. Venous leg ulcer pain can be persistent, even at rest [11], or may be
specifically related to, and exacerbated by, wound dressing-related procedures [12].
There are two physiological types of pain: nociceptive and neuropathic. Nociceptive
pain is defined as the normal physiological response to a painful stimulus [11]. Soft
tissue injury associated with nociceptive pain causes inflammation and stimulation of
peripheral nerve endings. The resulting hypersensitivity means that even minor
stimulation can cause intense pain. Neuropathic pain is caused by a primary lesion or
dysfunction in the nervous system [13] and may be caused by nociceptive pain,
ischaemia, diabetes or trauma that has damaged the peripheral nervous system and
altered the pain response.
An individual’s experience of wound pain is complex and is influenced by a wide range
of factors unique to them [14] [15]. Pain has a strong emotional dimension that is
influenced by previous experience [11]. Therefore it is no surprise that reduction of
pain is frequently cited as the highest priority from the patient’s perspective [2] [16].
The importance of adequate pain management associated with chronic wounds is
now becoming recognised in clinical practice because it can significantly improve
patients’ HRQoL and may indirectly promote healing by improving appetite and sleep
[17] [18].
People with painful CVLU feel their misery is never ending, Chase et al [19] coined the
term ‘forever healing’ to describe the extended time over which healing occurs. The
chronic illness experience of leg ulcer sufferers is dominated by persistent pain.
Strauss et al [20] and Miller [21] refer to this experience as the patient’s illness
trajectory. Improvement of the illness trajectory of people with CVLU requires effective
management of wound pain, thus further studies on the impact on HRQoL of painrelieving treatments are urgently needed.
This article describes the experiences of a group of patients with CVLU being treated
with a non-adhesive foam dressing releasing ibuprofen (Biatain-Ibu). The dressing
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consists of a soft, hydrophilic, non-adhesive polyurethane foam containing ibuprofen
(ibuprofen concentration: 0.5mg/cm²) as an integral part of the matrix. The foam is
bonded to a semi-permeable polyurethane film. Ibuprofen is released to the wound in
the presence of wound exudate and a study has shown that the dressing provides a
continuous pain-relieving effect [22].
In exudating wounds ibuprofen will be released in therapeutic concentrations into the
wound bed. A limited pain reduction effect could be due to many additional variables
that affect the individual pain experience. No relationship was observed in this study
between amount of wound exudate released and pain reduction.
The release of Ibuprofen is limited in a dry wound environment and therefore the
presence of dry necrotic tissue will impede any pain reduction. There was no evidence
in this study that moist slough interfered with the release of ibuprofen.
Heading 1
This prospective case series study aimed to:
1. Profile the characteristics and experience of individuals suffering from painful
venous leg ulceration.
2. Describe the experience of having a painful CVLU treated with a foam dressing
releasing ibuprofen.
Heading 1
Study design
The use of a prospective case study design allowed a more comprehensive
description of the pain experienced by people with CVLU and provided a richness of
information that cannot be conveyed adequately in a randomised controlled trial.
When considering the philosophical assumptions associated with qualitative research
it became apparent that a prospective case series was the methodology of choice.
The use of a control group was not considered in this instance as the study was not
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trying to demonstrate a treatment effect. It is hoped that the description of the
characteristics of CVLU pain may highlight the potential for new pain-reducing
therapies, leading to focused studies of stronger design in the future.
This case series used multiple triangulation, an approach that combines quantitative
and qualitative methods as a strategy for increasing depth of analysis and to minimise
biases inherent in any single methodology [23]. It combines two types of
methodological triangulation:
‘within-method’, which uses a variety of different data collection methods within
one paradigm, for example the use of wound measurement using planemetry
and photographs to monitor wound status (both quantitative methods)
‘between-method’, involving quantitative and qualitative data collection
approaches within one study [24].
Multiple triangulation analyses data from a variety of sources to provide a deeper
understanding of complex issues and encourages researchers to consider the data in
the widest possible way, instead of accepting findings from one methodological
paradigm. One of the original purposes of triangulation was to seek confirmation of
findings. In order to answer the research questions effectively, contrasting types of
data collection were used, including visual analogue scores (VAS), wound swabs and
ankle brachial pressure index (ABPI) measurements, in an attempt to enhance the
final analysis.
Much health-related research now uses triangulation as a blended, pragmatic
approach to gain an in-depth understanding of the phenomena in question [25]. Both
quantitative and qualitative approaches were seen as having equal value so that
findings from different perspectives could be evaluated [26]. This was considered to
be important when exploring the complex and highly personal nature of an individual’s
pain experience. See Figure 1 for an overview of the study.
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Caption: Figure 1 - Overview of study.
The study was carried out in Denmark and was conducted in accordance with the
Declaration of Helsinki. The study protocol was submitted to a local ethics committee
and written approval was obtained before inclusion of any participants in the study.
Written informed consent was obtained from all participating patients, after written and
verbal information was given regarding the nature of the study. Participants were free
to withdraw from the study at any time.
A case series design uses fewer samples more intensively than a quantitative study
[27], [28]. Participants were recruited purposefully to enable exploration of their
experiences of living with CVLU (see Table 1). In total, ten patients were recruited
from a wound clinic in a district general hospital. Data collection began in May 2004
and was completed in July 2005. All data collection was completed by two research
nurses: one conducted the participant interviews and the other was responsible for all
dressing changes. Once participants were recruited into the study, all care and data
collection occurred in their own homes. All research instruments were piloted on one
patient who was excluded from analysis as minor protocol modifications were
The study endpoints were a:
change in persistent venous leg ulcer pain before and after treatment
change in health-related quality of life before and after treatment
change in ulcer area before and after treatment.
Heading 2
Wound management protocol Each participant’s leg ulcer was cleaned and dressed
with the foam dressing releasing ibuprofen for six dressing changes, followed by
treatment with a non-pain relieving foam dressing (Biatain) in the non-active treatment
period (Figure 1). Dressings were changed every two or three days, extending the
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treatment period over two weeks. One patient had a four-day period between dressing
The frequency of dressing change can influence the pain experienced by patients.
Krasner conceptualises wound pain into two types: acute and chronic [29]. Acute
wound pain is associated with procedures such as dressing changes and
debridement, while chronic pain refers to background, persistent pain associated with
wounds. Patients in this study experienced both types of pain; however, intense
exacerbations of pain were experienced at dressing changes but also occurred at
other times of the day for no specific reason.
During the study, wound management was standardised using a protocol (Table 2).
During dressing changes, the nurse observed and recorded participants’ verbal and
non-verbal cues.
Heading 2
Quantitative data collection
Demographic data were collected, including participant age, gender, height, weight
and past medical history, together with wound-related data. Details of all medication
taken by participants at the beginning of the study were recorded at initial
assessment. Participants were asked to note how much analgesic medication they
took during the study and to record it in their personal diaries. They were asked to
keep their analgesic medication levels constant for the duration of the study. The fact
that this variable was not controlled should be borne in mind.
A standard leg ulcer assessment form was used to record ulcer details, including:
previous history, duration, location, aetiology, exudate levels, status of wound bed and
surrounding skin, wound size and type of compression therapy used, in accordance
with current recommended practice [30] [31]. The aetiology of each leg ulcer was
confirmed following full clinical examination and measurement of the ABPI. Only
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participants with venous leg ulcers as indicated by an ABPI of 0.8 and above were
included in the study in order to exclude people with mixed or ischaemic ulceration
because this could have influenced the individual’s pain experience [32] [33].
At each dressing change patients were assessed for any clinical signs of wound
infection that could indicate a rise in the wound’s bioburden and account for increased
wound pain. A wound swab was taken for microscopy, culture and sensitivity at the
start of the study to exclude infected wounds because infection is known to influence
wound pain [34]. Wound dimensions were recorded using wound tracing sheets and
surface area calculated using planimetry. The presence of inflammation was visually
assessed at the wound margin by the project research nurses, who recorded whether
or not erythema was evident. Finally, a digital photograph was taken of each ulcer at
the beginning and end of the study.
The intensity of venous leg ulcer pain experienced during the 24 hours before the
study began was measured using a validated visual analogue scale (VAS).
Participants completed a 100mm pain intensity horizontal VAS (least possible pain to
worst imaginable pain), which has been shown to be a successful method of
measuring pain intensity [35] [36]. The assessment was repeated immediately before
removal of the sixth and final dressing and one week after removal of the active
dressing. In line with established practice, previous scores were not shown to
participants. Participant diaries and interviews were used to substantiate VAS scores.
Heading 2
Qualitative data collection
Individual interviews were conducted with participants at the start of the study and
lasted approximately 40 minutes. Semi-structured interview schedules focused on
participants’ experiences of leg ulcer pain (Table 3a). Participants agreed to complete
written personal diaries describing their experiences of leg ulcer pain over the study
period of two weeks.
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Individual interviews were held with participants at the end of the active treatment
period (Table 3b). The timing of this interview encouraged reflection over the entire
treatment period. One week after removal of the foam dressing releasing ibuprofen
participants had a follow-up visit and were asked to evaluate their pain.
Heading 2
Data analysis
Data analysis was performed using data from the ten patients on the validated
statistical software ‘R’ version 2.10. Pair-wise comparisons between VAS scores for
baseline and final dressing change and between final dressing change and follow-up
were tested with a paired T-test. Similarly, pair-wise comparisons between wound
sizes were tested with a T-test; a correlation analysis was performed on baseline
wound size and pain. An analysis of variance (ANOVA) was performed with VAS
reduction (%) as a response variable and with the following explanatory variables:
patient age, reduction in medication, gender, duration of ulcer and previous ulcers. If a
variable tested insignificant it was successively removed until all variables were
Data analysis of participant interviews was conducted simultaneously with data
collection in order to allow follow-up in subsequent interviews and was based on the
principle of data 'reduction' and interpretation' [37]. Transcripts were read so that
major themes could be identified. Participants’ experiences were then coded.
Interpretation was facilitated by looking for recurring ideas and patterns within the data
and comparing these with the literature.
Heading 1
Findings and discussion
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The dominant and unrelenting nature of venous leg ulcer pain emerged as a central
theme from the data. One participant described their situation as being ‘locked in a
shell of pain’. Two major themes, characteristics of pain and the impact of pain, will be
discussed in detail, although many sub-themes were identified, which formed a
complex network of inter-related issues. Verbatim quotations from participants are
used to illustrate the depth and personal nature of participants’ pain experience.
Heading 2
Participant profile
Five men and five women, with a mean age of 67.9 years (range: 45-86), took part in
the study. All had chronic leg ulcers of longstanding duration, mean one year and four
months (range three months to seven years). Leg ulcer size was reduced in eight out
of the ten participants over the study period, but there were no significant differences
between baseline and final dressing wound sizes (Figure 2). Participant Number 6’s
wound became infected during the study, which may account for its increase in size.
VAS reduction depended on age (p = 0.02) and previous ulcers (p= 0.004) only, the
rest of the variables were insignificant. This meant that younger participants had
improved pain reduction with the foam dressing releasing ibuprofen. In addition,
participants with a previous history of leg ulceration experienced less of a painreducing effect with the dressing than participants presenting with an ulcer for the first
time. This corresponds well with the literature and emphasises that pain should be
treated as fast as possible because long-lasting pain becomes more difficult to treat
Figure 2 – Wound size development while wearing a foam dressing releasing
Table 4 summarises participant characteristics and results of pair-wise comparisons
between observed VAS and wound size.
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Heading 2
Characteristics of pain
Heading 3
Unrelenting pain The similarity between all participants’ experience of CVLU pain
was striking. All experienced severe unrelenting persistent pain punctuated by acute
episodes of intense pain. Ulcer pain and its effect dominated their descriptions of
living with a leg ulcer at the start of the study. Recurring adjectives were used to
describe the two elements of the ulcer pain. This persistent pain was described as
‘smouldering’ ‘nagging’ ‘creeping’ and ‘tugging’, emphasising its insidious and
dominant nature. Other descriptors such as ‘stabbing’, ‘burning’, ‘stinging’, ‘shooting’
‘like lightning’ and ‘electric shock’ suggest that venous leg ulcer patients in this study
also experienced intense periods of sudden pain more likely to be neuropathic in
origin, in addition to nocioceptive pain [11] [17]. The coexistence of these different
types of pain highlights the complexity of managing this type of chronic wound pain.
One individual likened her leg ulcer pain to trigeminal neuralgia, describing the pain as
like having ‘salt and chilli on the wound surface’. Others described their pain in similar
terms to this man:
‘I’ve had shooting pains so strong that I’d almost describe it as having a knife or an
axe in the ulcer. I’ve had pains that were so intense that I’ve cried out loud and
startled my family. I’ve had pains like cramps that have gone through the whole of the
(54-year-old man, ulcer duration: eight months.)
Although the pain experienced by participants was described as originating from the
wound surface, no relationship was demonstrated between the size of leg ulcer at
initial assessment and the reported pain intensity (see Figure 3). This was confirmed
by several participants during interview as they expressed a need for people to
believe their pain. In the words of one woman, ‘it’s good to get the point made that it
[the ulcer] hurts so much when it [the ulcer] didn’t look like much’ (her ulcer measured
5.9cm2 at initial assessment).
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Figure 3 – Pain-reducing effect (VAS) of a foam dressing releasing ibuprofen.
Pain was significantly higher at baseline compared to exclusion. Pain was also
significantly higher one week after the study compared to pain assessed at exclusion.
Patient 1 was prescribed morphine at follow-up, so the VAS score was not recorded.
Patient 8 experienced complete pain relief when treated with the dressing.
Heading 3
Unpredictability of pain The intensity and quality of the pain was described as
fluctuating throughout the day and night but was always present as background pain,
most frequently described as a ‘dull ache that pulls at the ulcer’. All participants
described the pain as originating within the ulcer itself, then radiating or shooting
sharply to the knee. The following description was typical:
‘The pain comes on out of the blue ... it comes somewhere from the middle of the
ulcer and it fans out from there … it’s almost stinging, burning and quite intense, and
then moves up the inside of my leg. It stops just under my knee, right there in the back
of my knee, and just carries on hurting. The pain’s on one side, and then it switches ..
like lightning jumping from one side to the other … and then it takes a couple to three
days before it dies down.’
(83-year-old woman, ulcer duration: four months.)
A variety of factors could change this persistent ulcer pain into an intense ‘burst of
pain’, including wound treatments and accidental limb trauma. In contrast with other
studies, procedures such as wound cleansing and wound swabbing were specifically
described as causing more pain than dressing removal [11]. The unpredictability of
pain was for many the most distressing feature to cope with. The sudden exacerbation
of pain for no apparent reason was frequently described as ‘a bolt out the blue’, often
experienced when resting or sleeping:
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‘It comes on like a shooting, burning pain … I’d almost describe it like someone
shooting darts straight into the ulcer. It’s like someone flicking on a “switch” and then
it sort of settles a bit, and then radiates towards the knee … before it moves down
again and circulates a bit like that.’
(50-year-old woman, ulcer duration: three months.)
These vivid descriptions illustrate that the pain may be focused at the site of the
wound itself (primary hyperalgesia), but extends to tissues peripheral to the wound
(secondary hyperalgesia) [39].
Heading 3
Pain intensity The mean baseline VAS score at the start of the study was 85mm
(range 74-96). Several authors have examined the distribution of VAS scores in
patients suffering various types of pain, including cancer pain, postoperative pain,
osteoarthritis and back pain, and agree that a VAS score greater than 60mm is
indicative of severe pain [36] [40] [41]. The intensity of venous leg ulcer pain
experienced by patients in this study (mean 85mm) is greater than the mean score of
44mm reported by Noonan and Burge [35] in a similar client group.
The mean baseline VAS score reduced from 85mm to 29mm (range 0-79) at final
dressing change before gradually rising to 41mm (range 3-67) at one week follow-up.
The pain intensity scores recorded during this study are shown in Table 4 and Figure
3. All participants reported an overall reduction of pain over the two-week study period
and a gradual return of pain at one week follow-up. Pain was reduced significantly
(p=0.003) in eight out of ten participants during the treatment period. All but one
participant reported a rapid decrease in pain between 30 minutes and a few hours
after application of the first dressing. Most patients expressed a reluctance to
withdraw from active treatment because they had experienced considerable pain
reduction during the active phase of the study. The results showed that eight out of
ten patients experienced increased pain when active treatment was discontinued
(Figure 3).
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Heading 2
Impact of pain
Heading 3
Living with restrictions In common with other studies, a consequence of leg ulcer
pain for the patients in this study was restricted mobility leading to periods of inactivity
and social isolation. This was a source of frustration [2] [6] [7]. This study suggests
that elderly, Danish leg ulcer patients appear to be generally more active than
contemporaries in other countries [15]. A high level of mobility was evident during
participant interviews: almost all were walking relatively long distances despite having
intense pain, and many still enjoyed cycling. Several elderly participants had recently
given up swimming, badminton and keep-fit classes because of worsening pain.
As participants’ pain reduced during treatment, mobility and energy levels improved.
They felt able to tackle household chores, go upstairs, walk and cycle further
distances and generally participate in family life:
‘I’m more active around the house and want to get on with things. I’m doing many
things which I haven’t done for ages. I think because I was so bothered by the pain so
it was like I was locked in a shell of pain and I can’t describe how happy I am now.’
(65-year-old woman, ulcer duration: seven months)
As treatment progressed, participants in employment returned to work and were able
to work longer days than previously. A significant improvement was also observed in
the participants’ gait during treatment. The majority noticed that their walking had
improved because they had been walking on tip-toe in an attempt to limit the pain
originating from the ulcer and this affected their mobility and confidence.
Heading 3
Dec 21st 2005 Response to reviewers
Living with fatigue Without exception, all participants experienced leg pain at night
that disturbed sleep, increased fatigue and drained energy: ‘the pain is quite terrible,
and saps all my energy … it has certainly drained me mentally, coping with constant
pain’. Many described ‘unbearable shooting pains’ and cramps in addition to their
persistent pain, which caused difficulty getting comfortable in bed and falling asleep:
‘I can’t bear having a duvet over me so I lie outside of the covers on a big fat cushion
with my leg up. But then in my sleep I turn over and knock the place where the ulcer is
which wakes me … all in all I’m sleeping no more than, well, maybe an hour or two at
(80-year-old woman, ulcer duration: seven months)
Disturbed sleep meant that many participants had to rest in the day, which further
reduced their activity levels and created anxiety about housework and chores and
limited social interaction.
All reported that walking was one of the most effective methods of relieving their leg
ulcer pain:
‘I can walk the pain off but it’s difficult to get going … I then walk as far as I can get
before I get tired and have to sit down. Walking spreads the pain out and it dies down
faster afterwards … as the pain tends to be worse at night I go on those walks every
single night, which is pretty tiring.’
(83-year-old woman, ulcer duration: four months)
For some, the need to walk day and night to dissipate the pain was a major source of
exhaustion and, ironically, several participants associated increased daytime walking
with the vicious cycle of worsened night pains. Many frequently woke up between 3am
and 4am with sharp stabbing pains that required them to get up and start walking,
which also disturbed the sleep of others.
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The sleep patterns of all patients improved during the active phase of the study, which
was key to improving morale, motivation and their ability to concentrate. Three people
slept through the night shortly after starting active treatment, without waking once:
‘Yes, I slept like a log that night [first night after treatment] I don’t think I ever slept so
well, and was thinking “I hope I never have to wake up and can just sleep and sleep
and sleep”.’
(62-year-old man, ulcer duration: four months)
All participants felt more positive as a result of improved sleep and felt that it would
help their ulcers to heal.
Heading 2
End of active treatment
The final patient interviews at the end of the active treatment period showed that nine
out of ten participants experienced rapid and immediate pain reduction. Pain was
reduced within 30 minutes to four hours, with the most frequent response being
between 30 minutes and one hour. Furthermore, the duration of the pain-reducing
effect was variable, ranging from relief during the first day with pain gradually returning
at night, to five days of continuous pain relief. Five participants (50%) reported
continuous pain relief of two to three days following dressing application.
‘I’ve been doing marvellously, especially this past week since I had the new treatment.
Yes, since then it’s improved day by day. Today I don’t have any pain, just a few
twinges, but that’s nothing. I can feel the ulcer is healing ... and it’s like ten times
better than winning the lottery, getting rid of all that pain. I can’t begin to describe how
splendidly I’ve improved.’
(65-year-old woman, ulcer duration: seven months.)
For the majority of participants, persistent wound pain was less intense when it
returned and intervals were greater between sudden onsets of acute pain episodes,
Dec 21st 2005 Response to reviewers
making the pain easier to cope with. Improvements in mood were observed by the
research nurses, participants and their friends and families and were evident from
most interviews:
‘Well, the pain has got far less bad. I’m not taking Ketogan (opioid pain-relief) —
they’re simply out of the picture. I haven’t had any pain for three days now. The ulcers
look better and I’m feeling bloody marvellous.’
(45-year-old man, ulcer duration: seven years.)
The majority of participants showed a stoic acceptance of their ulcer pain and
remained hopeful that their ulcers would heal. Many had low expectations and did not
expect to be pain free while their ulcer was open:
‘Once the pain has died down, when it’s just lurking there in the background then I feel
I’m doing really well.’
(83-year-old woman, ulcer duration: four months.)
As the pain lessened participants relaxed and felt more positive that their ulcer would
eventually heal. However, an unwelcome consequence of reduced wound pain meant
that some people became more aware of other general aches and pains such as joint
pains, backache and headaches.
Heading 2
Taking painkillers
Despite being asked to keep analgesic medication consistent throughout the study
five participants decided to reduce it as their pain reduced. Figure 4 shows the overall
reduction in amount and strength of analgesic medication taken during active
treatment. If participants had not been instructed to keep their medication constant, it
is likely that a larger reduction in analgesic intake would have been seen. Three
participants with a reduction of VAS scores of 53, 71 and 73mm did not alter their
medication as they followed the instruction given not to reduce analgesia.
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Participants exhibited a general reluctance to take oral analgesia due to concerns
about side effects and dependency and confusion about administration and dosages.
This tendency has been reported in other studies [42]. For most participants, their
prescribed analgesia had only a limited effect by taking the edge off the pain and were
only taken as a last resort. Only one younger participant appeared to understand the
rationale for sustained, regular administration of oral analgesics.
Figure 4 - Comparison of oral pain medication taken at the start and end of
active treatment with a foam dressing releasing ibuprofen. One dose of strong
opioids = 20mg morphine; one dose of weak opioids = 50mg tramadol or 25mg
codeine; one dose NSAIDs: 20mg tenoxicam or 50mg diclofenac; one dose
paracetamol = 1g paracetamol.
Heading 2
During the follow-up interviews one week after active treatment had stopped, eight out
of ten patients described a gradual return of the persistent ulcer pain but to a less
intense level than before (Figure 3). For the majority of the patients the persistent pain
typically returned between six and 12 hours after removing the last active dressing,
although their dressing-related pain at subsequent dressing changes was reported to
be less severe.
VAS scores for two patients showed minimal pain reduction. One reported no
improvement in pain intensity throughout the treatment period but acknowledged that
the dressing must have had more of an effect than initially scored as the pain returned
with such severity after cessation of active treatment. The other reported pain
reduction for the first two dressing changes before experiencing a gradual worsening
of pain during treatment. At follow-up, this participant noted that the pain had returned
Dec 21st 2005 Response to reviewers
to its pre-treatment intensity but confirmed that the persistent wound pain had become
intermittent during the study and had since returned to a persistent high level. The
nurse researcher who monitored this person for the duration of the study commented
that her pain ‘was “tattooed” into her experience of living with a chronic wound’.
Another interesting observation made by the nurse who interviewed a 65-year-old
female participant with her first leg ulcer of seven months’ duration was that ‘it has
been possible to effectively reduce the [ulcer] pain, which has not had time to develop
into a chronic pain experience’. Walshe [9] indicated that pain-reducing interventions
were sometimes reported to be inefficient due to negative expectations, increasing
age and previous experience. The two participants who responded least well shared
these reported characteristics. They were both over 70, had tried a lot of other
unsuccessful treatments and were resigned to their ulcer pain. In addition, there was
evidence that one wound was infected and that the other person’s wound pain was
likely to be primarily neuropathic in origin.
NSAIDs such as ibuprofen are targeted for nocioceptive pain arising from tissue
damage [43] [44]. The reduced effect of the active dressing in one participant
suggests that a neuropathic pain element arising from nerve damage was more
significant than the nocioceptive component. This effect may inform the clinician about
the nature of an individual’s pain and be helpful during the ongoing process of pain
Heading 1
Study limitations
Case series traditionally have been relegated to the lowest rungs of the evidence
hierarchy [45] because, in the past, isolated observations were collected in an
uncontrolled, unsystematic manner so that the information gained could not be
generalised to a larger population of patients. The quality of all studies, including
randomised controlled trials, vary widely and depend on the quality of their design,
execution and interpretation. However, case series studies are vulnerable to bias,
Dec 21st 2005 Response to reviewers
which is why a protocol was followed during this study for the wound management
procedures, data collection/analysis and documentation.
Triangulation has its critics because the trends emerging with the use of one method
of data collection and analysis may not do so with another [46]. In this study, findings
were corroborated, resulting in a broader, more complete interpretive analysis that
does not give greater accuracy, but adds breadth to the analysis.
Measuring an individual’s perception of pain is notoriously difficult and is influenced by
many uncontrollable variables. Local wound-related factors may account for the pain
reduction described by participants and requires further investigation. The decrease in
pain associated with the use of the active dressing could have been due to the
absorption of local inflammatory mediators present in chronic wound fluid. Schofield
et al [47] have recently examined perceptions of pain in elderly people. Their findings
demonstrate that older people have low expectations of pain-reducing interventions
and accept that pain is a normal part of their lives. Researchers and participants knew
that the treatment dressing contained an active analgesic, which may have biased
results. Care must be taken when interpreting VAS scores as a single entity because
uni-dimensional rating scales fail to reflect the complexity of pain. Pain intensity
ratings are known to vary on a daily basis and may be influenced by seasonal
changes, mood and anticipatory pain and are therefore dynamic measures that could
well be rated differently the following day [5] [48]. Therefore VAS scores should be
interpreted with caution and only considered within the context of participant
interviews, diaries and researchers’ notes. The findings related to pain reduction in
this study should be interpreted as indicative due to its qualitative design, although
there is new evidence that pain reduction in CVLU patients is associated with the
release of ibuprofen [22].
Heading 1
Dec 21st 2005 Response to reviewers
This study has attempted to describe the experience of living with a painful CVLU and
how improvements in HRQoL occurred when treated with a foam dressing releasing
ibuprofen. The data collectively revealed a range of experiences common to patients
with venous leg ulcers, including unrelenting persistent pain, unpredictable ‘bursts’ of
pain, fatigue and lives full of restrictions. The combined effect of persistent pain and
spontaneous intermittent bursts of intense pain is debilitating and distressing for
patients with venous leg ulcers. The lives of all participants were dominated by pain
originating from their CVLU, with many finding it difficult to cope with the unpredictable
nature of the pain. Analysis of demographic data, pain intensity scores, participant
interviews and diaries highlighted that persistent wound pain, although present all the
time, fluctuates over a 24-hour period and can be difficult to control. Persistent wound
pain has a negative influence on sleep and daily activities.
This study highlights the importance of thorough assessment to identify the
characteristics of wound pain such as duration, intensity and type. However, the
varying intensity of CVLU pain makes assessment challenging. Assessment could be
improved if patients were encouraged to describe their pain experience over 24 hours
so that patterns could be identified. This would allow targeting of appropriate
interventions (Table 5). Findings showed that once pain was controlled, patients could
‘forget’ that they had leg ulcers and get on with living their lives. This emphasises the
need to start pain intervention before anticipatory pain causes pain breakthrough.
This study highlighted several areas worthy of further investigation such as:
Exploration of factors affecting the intensity of CVLU pain, for example ulcer
duration, bacterial burden and sleep deprivation.
How assessment of the intensity of wound-related pain could be improved.
Evaluation of the effect of the new foam dressing releasing ibuprofen on other
types of wounds.
Findings support previous studies and provide further evidence that wound pain has a
negative influence on HRQoL and normal daily activities of patients with CVLU. Use of
Dec 21st 2005 Response to reviewers
this dressing was found to reduce wound pain significantly and improve health-related
quality of life. This study is primarily interpretive in approach and does not intend to
reflect the experiences of all people with painful CVLU, although it is becoming
increasingly difficult to ignore the collective experiences described by other
international studies.
This study was partially funded by an unrestricted grant from Coloplast A/S, Holtedam
1, 3050 Humlebæk, Denmark.
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Dec 21st 2005 Response to reviewers
Table 1: Inclusion/exclusion criteria
Inclusion criteria
Wound type Painful chronic venous leg ulcer, with an ABPI of 0.8 or higher.
Moderate to highly exuding.
Wound size
More than 2cm², but at all places the dressing edge must exceed the
wound edge by a 2cm margin.
Wound pain
Wound pain score of 3 or more on a VAS 100mm scale.
Male or female over 18 years old.
Patient must be evaluated as suitable for inclusion into study by
Patient must sign patient consent form before inclusion.
Exclusion criteria
Serious illness
Signs/symptoms of clinical infection.
Systemic treatment with corticosteroids or other
immunosuppressants in study period or within past month.
Active vasculitis, systemic lupus erythematosus, rheumatoid
Treatment with cytostatika within the past six months.
Pregnant or
Patient is pregnant or breastfeeding.
Patient has known allergy of dressing constituents.
Patient has known allergic reaction to ibuprofen, aspirin or
other similar pain-relieving drugs.
Patient must wear compression bandages.
Participation in other
clinical trials
Patients must not be participating in other clinical trials.
Table 2: Wound management protocol
Leg ulcers were cleansed with normal saline or tap water and the surrounding skin
patted dry.
The dressing should overlap the wound margin by 2cm and may be cut to fit if
necessary (dressing size 15 x 15cm).
Dec 21st 2005 Response to reviewers
The dressing should be applied with the foam side towards the wound surface.
The dressing may be secured with a secondary dressing or compression bandage.
The dressing must be changed when required, but not remain in situ for longer
than seven days. Dressing changes of between two and four days are preferable.
Compression bandaging was used as standard for all participants.
Table 3a: Interview schedule (baseline)
What does it feel like to have a leg Daily activities, mood, concerns/worries.
Try to describe the pain.
Location, intensity, frequency, duration, things
that alter the pain.
Describe how the pain affects your Activities, energy levels, sleep, mood, friends and
family, compression bandage.
What helps to ease the pain?
Pain-relieving strategies: medication, distraction,
heat, massage, talking about it, effectiveness.
Table 3b: Interview schedule (final)
How have you been since the first
Describe how the ulcer pain has
been since the first interview.
Describe how the pain has
affected your daily living since the
first interview.
How effective was this dressing?
Overview of effect of dressing: activities, mood,
Location, intensity, frequency, things that alter the
pain. If pain has changed describe how.
Activities, energy levels, sleep, mood, friends and
family, compression bandage.
Dec 21st 2005 Response to reviewers
Did it relieve the pain? Speed and duration of
effect, comfort, overall satisfaction, other effects.
Table 4: Patient characteristics and results of pair-wise comparisons between
observed VAS and wound size at inclusion and exclusion.
Patient age
Wound duration (months)
VAS (baseline)
VAS (final dressing)
VAS (follow up)
VAS reduction (baseline to
final dressing) (%)
VAS reduction (final
dressing to follow up)
Ulcer size reduction (%)
67.9 ± 14.9
1.01 ± 0.12
17.5 ± 26
85 ± 6.0
29 ± 30
41.2 ± 32
Pair wise |T| test P value
≤ 0.03
Difference not significant
≤ 0.0003
Table 5: Questions to improve assessment of painful venous leg ulcers
Do you hurt anywhere?
At what time of day is your pain* at its best and worst?
What makes your pain* better and worse?
*Note – patients may prefer to admit to aching, stinging or soreness rather than being
in pain.
Dec 21st 2005 Response to reviewers
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