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BMC Nursing
Research article Open Access
A randomised controlled trial to assess the effectiveness of a single
session of nurse administered massage for short term relief of
chronic non-malignant pain
Kate Seers*1, Nicola Crichton2, June Martin3, Katrina Coulson4 and
Dawn Carroll5
Address: 1RCN Research Institute, School of Health & Social Studies, University of Warwick, Coventry, CV4 7AL, UK, 2Institute of Primary Care
and Public Health, Faculty of Health and Social Care, London South Bank University, 103 Borough Road, London, SE1 0AA, UK, 3Lymphoedema
Clinic, Sir Michael Sobell House, Churchill Hospital, Old Road, Headington, Oxford, OX3 7LJ, UK, 4Pain Management Department, Derby
Hospitals NHS Foundation Trust, Derbyshire Royal Infirmary, London Road, Derby, DE1 2QY, UK and 5Senior Health Outcomes Manager, Sanofiaventis, Guildford, Surrey, UK
Email: Kate Seers* – [email protected]; Nicola Crichton – [email protected]; June Martin – [email protected];
Katrina Coulson – [email protected]; Dawn Carroll – [email protected]
* Corresponding author
Abstract
Background: Massage is increasingly used to manage chronic pain but its benefit has not been
clearly established. The aim of the study is to determine the effectiveness of a single session of
nurse-administered massage for the short term relief of chronic non-malignant pain and anxiety.
Methods: A randomised controlled trial design was used, in which the patients were assigned to
a massage or control group. The massage group received a 15 minute manual massage and the
control group a 15 minute visit to talk about their pain. Adult patients attending a pain relief unit
with a diagnosis of chronic pain whose pain was described as moderate or severe were eligible for
the study. An observer blind to the patients’ treatment group carried out assessments immediately
before (baseline), after treatment and 1, 2, 3 and 4 hours later. Pain was assessed using 100 mm
visual analogue scale and the McGill Pain Questionnaire. Pain Relief was assessed using a five point
verbal rating scale. Anxiety was assessed with the Spielberger short form State-Trait Anxiety
Inventory.
Results: 101 patients were randomised and evaluated, 50 in the massage and 51 in the control
group. There were no statistically significant differences between the groups at baseline interview.
Patients in the massage but not the control group had significantly less pain compared to baseline
immediately after and one hour post treatment. 95% confidence interval for the difference in mean
pain reduction at one hour post treatment between the massage and control groups is 5.47 mm to
24.70 mm. Patients in the massage but not the control group had a statistically significant reduction
in anxiety compared to baseline immediately after and at 1 hour post treatment.
Conclusion: Massage is effective in the short term for chronic pain of moderate to severe
intensity.
Trial Registration: [ISRCTN98406653]
Published: 4 July 2008
BMC Nursing 2008, 7:10 doi:10.1186/1472-6955-7-10
Received: 19 December 2007
Accepted: 4 July 2008
This article is available from: http://www.biomedcentral.com/1472-6955/7/10
© 2008 Seers et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0),
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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Background
Complementary therapies, such as massage, are increasingly used by health professionals to manage a wide range
of symptoms, including pain [1]. A literature search
revealed a paucity of well-designed randomised controlled trials to determine the effectiveness of massage for
chronic pain. This study aims to determine whether a single session of massage reduces short term pain and anxiety
in patients with chronic pain.
The use of complementary therapies is steadily growing,
both in Europe and in the US [2-4]. Health care practitioners are increasingly incorporating such therapies within
their care [5]. This increased used is despite lack of evidence of effectiveness [6]. Health professionals’ desire to
deliver best practice is coupled with government initiatives to ensure an evidence based approach to care. For
example, in the UK the National Institute for Clinical
Excellence and NHS Quality Improvement Scotland have
been set up; in the US the Agency for Health Care Research
& Quality, and in Australia the National Institute for Clinical Studies all to try and ensure the health care delivered
is based on what is known to be effective [7-10].
The holistic nature of nursing means massage is an attractive intervention for nurses to be able to offer patients. In
addition to any direct therapeutic benefit, it allows nurses
time with patients. It may be particularly relevant in settings where patients need immediate relief. Many nurses
have undertaken courses in massage, however there is little robust evidence of its effectiveness. In today’s evidence
driven health care environment, if nurses are to justify the
resources involved in training and delivery, they need evidence that massage is an effective treatment.
A literature search of Medline, EmBase, Cinahl and the
Cochrane Controlled Trials Register and Cochrane Database of Systematic Reviews was undertaken, using free text
and MeSH terms. Studies were sought which were randomised controlled trials, of manual massage therapies
with or without oils, and which compared massage to at
least one other treatment group (including usual care) in
patients with chronic non malignant pain. Studies were
excluded if they used non-manual massage or where massage was administered as part of a combination of therapies or was used for acute pain. Twenty eight studies were
identified, of which eight met the criteria for inclusion.
After the RCT described in this paper was completed, a
systematic review of massage for low back pain was published [11]. Outcomes considered in this review were
pain, return to work, subjective change in symptoms and
functional status. This superseded the literature review
carried out prior to the conduct of the RCT reported in this
paper. The systematic review concluded that massage
might be beneficial for subacute and chronic non-specific
low back pain, but that more studies were needed to confirm these conclusions [11]. Two of the RCTs included in
review [11] found patients had less anxiety after massage
[12,13]. Studies of chronic pain other than low back pain
have found less anxiety and less pain [14-16].
In summary, despite the widespread and increasing use of
massage for chronic pain, evidence of effectiveness is lacking, studies tend to be small and properly controlled studies are needed. An RCT to assess the effectiveness of
massage for chronic pain was thus designed to add to the
knowledge base in this area.
Methods
Aim
The aim of the study is to determine the effectiveness of a
single session of nurse-administered massage for the short
term relief of chronic non-malignant pain and anxiety.
Design
A randomised controlled trial design was utilised, in
which the patients were assigned to two groups by simple
block randomisation, using blocks of 10. Randomisation
was carried out by use of a computerised random number
generator and provided from a central office unconnected
with the study. After obtaining informed consent from the
patient, the allocation was obtained by telephone from
the central office, thus allocation was concealed.
Sample and Setting
Patients aged 18 and over and attending a regional pain
relief unit in England as in or out patients, who had experienced pain for three months or longer, whose pain was
described as moderate or severe on the four point verbal
rating pain intensity scale were eligible for the study.
Patients were excluded if they did not speak English, did
not consent or if they had taken any analgesics in the two
hours prior to treatment. Outpatients were being followed
up for the management of their chronic pain, and inpatients were admitted to the pain unit where patients
stayed for one or more days in order to investigated ways
of controlling their pain. The participants were a consecutive series of eligible patients and data collection took
place between 1998 and 2000.
Interventions
The experimental group received a 15 minute manual
massage of their back, neck and shoulders using sweet
almond oil. The control group received a 15 minute visit
to talk about pain clinic treatment. The treatment for both
the experimental and control groups was carried out by
two registered nurses qualified in massage (ITEC
diploma). Each therapist (JM, KC) performed a sequence
of the same massage techniques with the patients in the
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massage treatment group. This involved effleurage, petrissage and kneading techniques. For patients in the control
group the therapist visited the patient for 15 minutes and
encouraged them to talk about their pain and pain treatment. This is representative of usual care in this pain
clinic, where health care staff talk to patients about their
pain and its management, and no massage was performed
for the control group. Patients in both groups were asked
to try and complete at least one full hour after the intervention before requesting analgesics, but could request
analgesics at any time after the intervention. If they
received an analgesic, they were then excluded from any
further follow-up assessments.
Outcomes
An independent nurse observer (DC), blind to the
patients’ treatment group, carried out assessments of the
patient. These were carried out immediately before treatment (baseline), immediately after treatment (post treatment) and at 1, 2, 3 and 4 hours after treatment. The
observer also recorded whether or not the patient had broken the blinding by inadvertently revealing their group
allocation (for example, by referring to “my massage”).
Once blinding was broken, it was considered unblinded
for all subsequent assessments for that patient.
Pain intensity was assessed using a 0–100 mm visual analogue scale (VAS), the four point verbal rating pain intensity scale with descriptors of none = 0, mild = 1, moderate
= 2 and severe = 3, both have been shown to be reliable,
valid and appropriate for clinical use [17], and The McGill
Pain Questionnaire Pain Rating Index [18]. Pain Relief
was assessed using five point verbal rating scale with
descriptors of none = 0, slight = 1, moderate = 2, good = 3
and complete relief = 4. Anxiety was assessed with the six
item Spielberger short form State-Trait Anxiety Inventory,
[19]. At the end of the study period patients made an overall rating of the study treatment using a five point scale
(poor = 0, fair = 1, good = 2, very good = 3 or excellent =
4). They also rated whether they had achieved 50% pain
relief [20].
Sample Size
The sample size was calculated for comparing mean difference in pain score and for the study to have a power of
90% [21]. The results of a study of pain relief through
relaxation in elderly hip fracture patients suggests that
when using a pain scale rating pain from 1 to 10 that the
standard deviation for patients with chronic pain on this
scale is 2.5 [22]. On this scale a mean difference of 1.5 in
pain scores between the treatment groups could be considered clinically worthwhile. Since in the current study a
100 mm VAS pain scale will be used a standard deviation
of 25 mm and a mean difference of 15 mm are consistent
with the earlier study [22]. With type I error set at 0.05,
then the study would require 60 patients per group. If a
difference as large as 20 mm between the pain scores was
attained this could be demonstrated with 34 patients per
group. In the current study it was decided, based on the
difference found in the previous study of elderly hip fracture patients, recruit 60 to each group: a total of 120
patients.
Ethical considerations
The study received ethical approval from the Local
Research Ethics Committee (Study Code NAPREC
97.053). All participants recruited to the study had
received a verbal explanation of the study and were provided with a written information sheet. All potential participants had at least 24 hours between receiving
information and deciding whether or not they wished to
take part in the study. All participants gave written consent.
Data analysis
In the analysis baseline pain and anxiety scores are compared for the two treatment groups using t-tests. To investigate the treatment effect, for each patient their pain
scores after treatment are compared to their baseline pain
score (pre-treatment). The mean difference in change in
pain score for the two treatment groups is compared using
a 2 sample t-test. Similarly changes in anxiety between
baseline and post treatment are compared for the two
groups sample t-test. Box plots are used to show graphically the differences between groups. The box includes the
25th, 50th and 75th percentiles; the whiskers indicate the
range of the data, with asterisks indicating outliers. Statistical significance was set at the 5% level. The data were
analysed using SPSS version 12 and MINITAB version 13.
Results
In total 103 patients participated in the study of whom 52
were randomly allocated to the massage group and 51 to
the control group. Two patients allocated to the massage
group withdrew at baseline, one because they received
morphine just prior to starting the study and the other
because they were unable to understand the assessment
scales, thus the analysis reports results for the 101 patients
who completed the baseline assessments. The patients
were aged between 21 and 81 years, with mean age 53.4
years (SD 13.3 years) and 58.4% were female. The mean
time that the patients had experienced chronic pain was
10.4 years (SD 8.94 years). 87% of the patients had a diagnosis which included back pain and 58% had more than
one pain site. At baseline, 60.4% had moderate and
39.6% had severe pain as recorded on the verbal rating
scale.
Figure 1 shows the number of patients still taking part in
the study at each assessment point. After the first hour the
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drop out from both groups, but particularly from the control group was rapid. By the 2 hour post-treatment assessment only 23% of patients in the control group remained
in the study and by the 3 hour assessment only 10% of the
control group were available for assessment. In comparison for the massage group 72% of patients remained in
the study at 2 hours post-treatment, 54% at 3 hours and
36% at 4 hours post treatment. Because of the very high
withdrawal rate at 2, 3 and 4 hours after treatment, the
results from these time periods are impossible to interpret
and are therefore not presented.
The assessment of the patients at all time points was by an
observer who was blind to the treatment that the patient
received (DC). Occasionally the patient would break the
blinding by comments that they made to the observer. For
89 of the 100 patients in which a record of blinding was
made, the observer remained blind throughout the assessment, so blinding was maintained in 89% of patients.
The demographic characteristics and baseline scores for
the massage and control groups are compared in Table 1.
Comparisons between massage and control groups were
tested using chi-squared or two sample t-tests as appropriParticipant Flow at each stage of study Figure 1
Participant Flow at each stage of study.

Enrolment
Excluded (n=10)
Not meeting inclusion criteria – only mild
pain at baseline (n=9)
Other Reasons – did not attend (n=1 )
Analysed:
Baseline (n=50)
Immediately after treatment (n=50)
1 hour after treatment (n=50)
2 hours after treatment (n=36)
3 hours after treatment (n=27)
4 hours after treatment (n=18)
Reason – additional painkillers
requested

Follow-Up
Allocation
Analysed:
Baseline (n=51)
Immediately after treatment (n=51)
1 hour after treatment (n=50)
2 hours after treatment (n=12)
3 hours after treatment (n=5)
4 hours after treatment (n=4)
Reason – additional painkillers
requested

Analysis
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ate. There are no significant differences in the age, gender
mix or duration of pain for the two treatment groups.
The pain verbal rating scale scores are “moderate” or
“severe” for all patients, with 40% of the massage group
and 39% of the control group recording severe pain at
baseline. The similarity of the distribution of pain scores
between the two groups is shown in the boxplot in Figure
2.
Comparisons post-treatment of pain VAS scores are
shown in Figure 3 and Table 2. Figure 3 illustrates that the
95% confidence intervals for mean pain VAS for the massage and control groups overlap at baseline, the means are
not significantly different. However, the confidence intervals are clearly distinct both immediately post treatment
and at 1 hour post treatment, consistent with the massage
group having significantly lower mean pain VAS. For the
control group mean pain VAS for those who continue
beyond 1 hour (the minority) is 36.4, but mean pain VAS
for those in the control group who withdraw at 1 hour
(the majority) is 74.7, a significantly higher mean (p <
0.001).
Table 2 compares the baseline score to that immediately
post treatment, the massage group experience a statistically significant (p < 0.001 using paired t-test) mean
reduction in pain of 16.7 mm (SD 21.2). For the control
group the mean change in pain score is -0.04 mm (SD
16.0) which is not significant (p = 0.985 using paired ttest). For those in the massage group there is a significantly greater reduction in pain score both immediately
post treatment and at 1 hour post treatment than in the
control group. The 95% confidence interval for the difference in mean pain reduction at one hour post treatment
between the massage and control groups is 5.47 mm to
24.70 mm, that is the massage group can expect on average to benefit by between 5.47 mm and 24.70 mm greater
reduction than the control group up to one hour post
treatment.
Figure 4 illustrates the reduction in pain VAS score for the
massage group and the negligible change in pain VAS
score for the majority of members of the control group.
For both groups the median is central in the box of the
boxplot, thus supporting the assumption that the data is
normally distributed and that a t-test can be used to compare these changes.
The results from the four point verbal rating pain, the four
point pain distress scale and the McGill Pain Questionnaire produce the same findings as the pain VAS scale.
That is, statistically significant differences between massage and control groups immediately and one hour post
treatment.
An example of these similarities is shown in comparisons
of McGill Pain Questionnaire scores from baseline to
immediately post treatment. The massage group experience a statistically significant (p < 0.001 using paired ttest) mean reduction in McGill pain score of 11.5 (SD
9.93). For the control group the mean change in McGill
pain score is 1.22 (SD 7.16) which is not statistically significant (p = 0.237 using paired t-test).
Table 1: Comparison of the characteristics of the massage and control groups at baseline (pre-treatment)
Characteristic Massage group Control Group p-value
Number in group 50 51
Gender (male:female) 22:28 20:31 0.626 NS
Age in years Mean (SD) 51.5 (13.4) 55.2 (12.9) 0.171 NS
Duration of pain in years. Mean (SD) 9.86 (7.47) 11.0 (10.2) 0.540 NS
Therapist (A:B) 27:23 27:24 0.915 NS
Pain VAS. Range 0–100. Mean (SD) 57.7 (18.0) 62.3 (16.6) 0.200 NS
McGill Pain Q’aire Pain Rating Index Range 0–78 Mean (SD) 27.3 (11.5) 25.1 (14.4) 0.390 NS
Spielberger SF STAI Range 6–24 Mean (SD) 13.3 (4.16) 12.0 (4.15) 0.139 NS
Baseline (pre-treatment) pain and control groups Figure 2 VAS scores for the massage
Baseline (pre-treatment) pain VAS scores for the
massage and control groups.
Massage Control
20
30
40
50
60
70
80
90
100
Treatment Group
Pain VAS score
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Table 2: Comparison of massage group and control group for both pain VAS scores and changes in pain VAS score from baseline, at
post treatment assessments*.
Time point Massage group Control group p-value (2 sample t-test)
Mean SD N# Mean SD N#
Baseline score 57.7 18.0 49 62.3 16.6 47 0.200 NS
Immediately post treatment score 41.1 20.2 49 62.8 20.9 47
Change from baseline 16.7 21.2 48 -0.04 16.0 45 0.000
1 hour post treatment score 44.8 23.5 47 64.9 26.7 43
Change from baseline 12.4 21.3 47 -2.66 24.0 41 0.002
* Note that at each time point adding the change from baseline scores to the post treatment scores will not necessarily equal the baseline scores,
because some patients have dropped out after the baseline
SD = Standard Deviation
NS = Not significant
# the table has some missing data on VAS scores at baseline, but data available on other outcomes. One participant in the massage group and 3 in
control group did not complete VAS pain scores, and thus were not included in the later comparisons to baseline.
Table 3 showed, using a chi-squared test, a significant
association between treatment group and whether the
patient gets 50% pain relief, with only one person in the
control group but 18/31 and 18/32 patients in the massage group reporting 50% pain relief immediately post
and 1 hour post treatment.
Table 4 illustrates results from the Spielberger short-form
anxiety scale. It shows that comparing the baseline score
to that immediately post treatment, the massage group
experience a statistically significant (p < 0.001 using
paired t-test) mean reduction in STAI score of 3.57 (SD
3.02). For the control group the mean change in STAI
score is 0.00 (SD 3.39) which is not statistically significant
(p = 1.00 using paired t-test). For those in the massage
group there is a statistically significantly greater reduction
in anxiety score both immediately post treatment and at 1
hour post treatment than in the control group. The 95%
confidence interval for the difference in mean anxiety
score reduction at one hour post treatment between the
massage and control groups is 1.67 to 4.36 that is the massage group can expect on average to benefit by between
1.67 and 4.36 greater reduction in anxiety score than the
control group up to one hour post treatment.
At the final assessment for the patient, either at 4 hours
post treatment or at the point that they requested an analgesic and thus withdrew from the study the patient was
asked to assess whether the treatment they had received
Mean and 95% confidence inte scores for the massage group (- – – – -) and the control group () at three time points Figure 3 rval for the mean pain VAS
Mean and 95% confidence interval for the mean pain
VAS scores for the massage group (- – – – -) and the
control group (⎯) at three time points.
Change in pain VAS score between baseline and immediately post treatment for both the group Figure 4 massage group and the control
Change in pain VAS score between baseline and
immediately post treatment for both the massage
group and the control group. The change is calculated as
baseline – post-treatment, so positive values indicate pain has
been reduced by treatment.
Massage Control
-50
0
50
Treatment Group
Change in Pain VAS score
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was poor, fair, good, very good or excellent. In the massage group, 34 rated the treatment as good, very good or
excellent, 12 as fair and 4 as poor. In the control group, 4
rated it as good, very good or excellent, 14 as fair and 33
as poor. A chi-squared test for the patients’ assessment of
the treatment demonstrates that those receiving the massage rate this treatment statistically significantly better
than the control group (X2 = 46.6, df = 2, p < 0.001).
At the final assessment the patient was asked whether they
would like to have the treatment again. A significantly
higher proportion of those in the massage group (X2 =
24.4, df = 1, p < 0.001) said they would like the treatment
again. Of the 49 patients in the massage group who were
asked this question all 49 (100%) said yes they would like
the treatment again. Of the 42 patients in the control
group asked this question, 25 (60%) said yes they would
like the treatment again.
Discussion
This study showed that, compared to baseline, massage
reduced pain and anxiety for up to one hour. There were
no such differences for the control group. This suggests
that massage could be a useful short term intervention, to
reduce both pain and anxiety. Although an hour’s pain
relief after a massage may seem a short duration, this
could be very worthwhile if, for example, the patient is
anxious or fearful about a procedure they are about to
undergo, or they are waiting for an analgesic to take effect,
or to give them some short term respite from pain during
the day and thus a sense of a degree of control over the
pain.
The results showed that these patients with moderate to
severe chronic pain are used to taking analgesics, with
77% of patients in the control group dropping out to take
an analgesic after one hour post intervention, and 92%
control patients had dropped out by 4 hours post intervention.
One of the problems of demonstrating any statistically
significant effect of massage over time was the large drop
out rate. Once the patient had taken an analgesic, the
effects due to the massage could no longer be reliably elicited and they had to be excluded. The differential drop out
rate between the groups is interesting. At 2 hours post
treatment 72% of patients having massage compared to
only 23% of those in the control group remained in the
study. At 3 hours post treatment 53% of massage patients
compared to only 10% of control patients remained. At
the final assessment after 4 hours, over a third (36%) of
massage patients remained compared to only 8% of those
in the control group. This gives at least an indication that
because patients who dropped out did so because they
requested an analgesic, those in the massage group who
stayed in the study did so because they had less pain.
The study had aimed to recruit 120 patients, 60 in each
group. In the event, 101 were included in the study. This
was based on a previous study of relaxation in hip fracture
Table 4: Comparison of massage group and control group for both Spielberger STAI scores and changes in STAI score from baseline,
at post treatment assessments.
Time point Massage group Control group p-value
Mean sd n Mean Sd N
Baseline score 13.3 4.16 50 12.0 4.15 47 0.139 NS
Immediately post treatment score 9.72 3.43 47 12.2 5.15 47
Change from baseline 3.57 3.02 47 0.00 3.39 44 0.000
1 hour post treatment score 10.5 3.90 50 12.8 5.06 47
Change from baseline 2.74 3.10 50 -0.28 3.43 43 0.000
Table 3: Comparison of massage group and control group for 50% pain relief at post treatment assessment.
Time point Massage group 50% pain relief Control group 50% pain relief p-value
Yes No Yes No
Immediately post treatment
Change from baseline
18 31 0 51 0.000
1 hour post treatment
change from baseline
18 32 1 49 0.000
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patients which had a standard deviation of 25 mm and a
mean difference of 15 mm [18]. If we take the actual VAS
pain scores comparing baseline to immediately post treatment, there is a mean difference of 16 mm and a standard
deviation of 21 mm. For a mean difference and standard
deviation of this size a sample size of 45 per group, gives
power of 95%. So, looking at this outcome, the study is
adequately powered.
The extent of a statistically significant reduction of pain
and whether it is clinically significant is important to consider. Compared to baseline, those in the massage group
had a mean reduction in pain of 16.7 mm on a 0–100
scale immediately after treatment. If 50% pain relief is
taken as clinically important, 36% of the massage group
reported at least this level of relief immediately post treatment, compared to 0% of the control group. This provides
some evidence that the massage can have quite a large
effect in just over a third of patients. Although a benefit of
reduced pain for one hour may seem a limited effect, it
does provide something of a break from pain.
It is then a clinical question whether the 15 minute investment of time in doing the massage is worth the benefits
outlined in the paper. When patients either completed the
study or withdrew, 68% of massage patients compared to
only 8% of control patients said the intervention had
been good, very good or excellent, so it would seem over
two-thirds of patients did find the treatment beneficial.
This could be one area where carers may be able to take on
this role, although anecdotally, we are aware that some
clinicians may be reluctant to make this suggestion to carers, fearing litigation if there are any adverse effects.
Health professionals wishing to integrate massage into
their practice need to consider professional training, and
the requirements of the regulatory bodies of their own
country. For example, in the UK, the Royal College of
Nursing produced guidance on integrating complementary therapies into clinical care [23]. It would also be sensible to liaise with the appropriate committees within
their own hospital or community setting regarding the
level of training required to practice (for example, the formal structures addressing risk management, quality assurance and professional development).
This study adds to the international knowledge base
about the effectiveness of massage for chronic pain. It has
demonstrated that massage can produce short term reductions in pain and anxiety, and improvements in pain relief
which are valued by patients. These are important potential benefits for people in whom the management of pain
is often a challenge.
Conclusion
Massage is effective in the short term for chronic pain of
moderate to severe intensity, and has a small anxiety
reducing effect. It could be a useful addition to techniques
offered to patients as part of their care. Nurses are well
placed to be trained in and to deliver massage. More
research is needed to explore the benefits of repeated
treatments of massage in patients with chronic pain.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
KS conceived the study and participated in its design and
coordination and drafted the manuscript. NC participated
in the design, conducted the statistical analysis and
helped to draft the manuscript, JM and KC were involved
in the data collection, delivering the intervention and
helped draft the manuscript, DC participated in the design
of the study and the data collection and helped draft the
manuscript. All authors read and approved the final manuscript.
Acknowledgements
This study was funded by the Oxfordshire Health Services Research Fund.
The funder was not involved in the design, conduct or interpretation of the
study. Thank-you to all patients and staff involved in this study for their time
and support.
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