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DM, et al. The natural history of lone atrial fibrillation. N Engl J Med
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(Accepted 15 September 1999)
Pragmatic randomised controlled trial of local
corticosteroid injection and naproxen for treatment of
lateral epicondylitis of elbow in primary care
Elaine M Hay, Susan M Paterson, Martyn Lewis, Gillian Hosie, Peter Croft
Objective To compare the clinical effectiveness of
local corticosteroid injection, standard non-steroidal
anti-inflammatory drugs, and simple analgesics for the
early treatment of lateral epicondylitis in primary care.
Design Multicentre pragmatic randomised controlled
Setting 23 general practices in North Staffordshire
and South Cheshire.
Participants 164 patients aged 18-70 years presenting
with a new episode of lateral epicondylitis.
Interventions Local injection of 20 mg
methylprednisolone plus lignocaine, naproxen 500
mg twice daily for two weeks, or placebo tablets. All
participants received a standard advice sheet and
co-codamol as required.
Main outcome measures Participants’ global
assessment of improvement (five point scale) at four
weeks. Pain, function, and “main complaint” measured
on 10 point Likert scales at 4 weeks, 6 months, and 12
Results Over 2 years, 53 subjects were randomised to
injection, 53 to naproxen, and 58 to placebo. Prognostic
variables were similar between groups at baseline. At
4 weeks, 48 patients (92%) in the injection group were
completely better or improved compared with 30
(57%) in the naproxen group (P<0.001) and 28 (50%)
in the placebo group (P<0.001). At 12 months, 43
patients (84%) in the injection group had pain scores
<3 compared with 45 (85%) in the naproxen group
and 44 (82%) in the placebo group (P>0.05).
Conclusions Early local corticosteroid injection is
effective for lateral epicondylitis. Outcome at one year
was good in all groups, and effective early treatment
does not seem to influence this.
that affects about 4 adults per 1000 annually.1Most cases
are managed in primary care, and more than 40
possible treatments have been proposed,2reflecting a
lack of consensus about optimal management. General
inflammatory drugs to treat tennis elbow, but there are
no trials comparing them with painkillers and one study
found no clinically important benefit over placebo.3Two
reviews of corticosteroid injections concluded that there
was insufficient evidence to support their use in treating
tennis elbow, but the methodological quality of most
trials was poor.4 5Only two primary care studies were
A further table and
members of the
are given on the
Stoke on Trent
Elaine M Hay
senior lecturer in
BMJ VOLUME 3199 OCTOBER 1999 www.bmj.com
identified, both with methodological shortcomings,
including small sample sizes. One, in an occupational
health centre, showed no difference between injection,
indomethacin, and a wrist brace over 12 months.6The
between ultrasound, transcutaneous nerve stimulation,
and local injection five days after intervention.7
We conducted a large pragmatic randomised trial
comparing three conventional treatments for lateral
epicondylitis in primary care. The aims of the study
wereto determine whether
injection, a two week course of naproxen, or simple
analgesia provides the best short term treatment for
new episodes and which of these treatments provides
best long term relief of symptoms.
The study was a multicentre,pragmatic randomised trial
in primary care. We recruited consecutive patients aged
18-70 years who consulted their general practitioner
with a new episode of lateral epicondylitis (pain and ten-
derness in the lateral region of the elbow and no consul-
tation with symptoms in the same elbow during the
preceding 12 months) during November 1995 to
December 1997. Exclusion criteria were a history of
inflammatory arthritis or gross structural abnormality of
the elbow; contraindications to non-steroidal anti-
inflammatories or local steroid injection;and pregnancy
or breast feeding. The trial was explained to patients by
their general practitioner, who gave participants an
information leaflet and faxed a registration form to the
research centre. Baseline assessments were performed
by a study nurse (usually in the patients’ homes) within
two working days of registration. Written informed con-
sent was obtained, and the study was approved by the
local research ethics committees of North Staffordshire
and South Cheshire.
Treatment allocation was according to the study
number given to the patient at the baseline assessment.
Numbers were issued in a predetermined random
sequence in blocks of six by general practice and gen-
erated with a random number table. The number cor-
responded with that on identical treatment packs kept
in the general practitioners’ surgeries.
Patients returned to their general practitioner after the
baseline assessment to receive one of three treatments.
Injection group—Patients were given a local cortico-
steroid injection of methylprednisolone 20 mg and 0.5
ml 1% lignocaine according to a standard technique.
The injection was performed with the patient’s arm rest-
ing flexed on a firm surface. The methylprednisolone
and lignocaine were drawn up in separate syringes.After
the skin was cleaned, lignocaine was injected deep into
the subcutaneous tissues and muscles 1 cm distal to the
lateral epicondyle and aiming towards the tender spot.
The syringes were then exchanged and methylpred-
nisolone injected radially. The needle was withdrawn
cleanly and firm pressure applied.
Naproxen group—Patients were prescribed enteric
coated naproxen 500 mg twice daily for two weeks.
Standard advice was given to take the drug with food
and about potential side effects.
Placebo group—Patients were give placebo tablets
(unmarked vitamin C) twice daily for two weeks. Stand-
ard advice was given as for the naproxen group.
Participants were provided with co-codamol for
additional pain relief and an information leaflet about
“tennis elbow” based on the Arthritis Research
Campaign publication but omitting specific treatment
Outcome assessments were performed by a blinded
study nurse before randomisation and at four weeks,
six months, and 12 months. The baseline assessment
also included demographic variables, medical history,
and potential prognostic variables. Case notes were
reviewed after completion of follow up.
The primary outcome was patients’ global assess-
ment of change measured on a 5 point scale (complete
recovery, improved, no change, worse, much worse) at
four weeks. Secondary outcomes were pain severity (10
point Likert scale); impairment of function (10 point
Likert scale);severity of “main complaint”(10 point Lik-
ert scale)8; disability (validated tennis elbow disability
questionnaire)9; pain free grip strength in affected arm
(average of two readings with hand held dynamometer);
local tenderness of lateral epicondyle (3 point scale:
none, some, definite with flinch); pain on resisted exten-
sion of middle finger and wrist with arm extended (3
point scale: none, some, definite with flinch); number
and type of co-interventions (questionnaire and case
note review); time off paid employment; complications
of treatment (post-intervention exacerbation of pain
(daily 10-point pain scale measured for five days), local
skin atrophy,gastrointestinal side effects).
Sample size calculations were based on publications
which describe a 70% recovery or improvement with
non-steroidal anti-inflammatory drugs after four weeks
(two tailed ? = 0.05, ? = 0.2).10Overall success was
defined a priori as a 20% difference between treatment
groups in the primary outcome measure. A total
sample size of 180 patients was required.
Intention to treat analysis was performed blind to
treatment group. All hypothesis tests were two tailed
with ? = 0.05. We compared groups with ?2test for
nominal variablesor Fisher’s
appropriate for small samples. Ordinal variables were
compared by Mann-Whitney U tests. Area under the
curve slopes were compared by the methods of
Matthews et al.11Analyses were carried out with spss
Thirty seven general practitioners from 23 practices
registered 182 patients. Of these patients, 164 (78
women) were randomised:53 to receive local injection,
53 to naproxen, and 58 to placebo. Eleven of the 37
general practitioners recruited six or more patients,
accounting for 94 (57%) of the 164 in the study popu-
lation (overall range recruited 1-17). Allocation of
intervention and baseline patient characteristics were
similar in high recruiting and low recruiting practices.
University School of
Stoke on Trent
Susan M Paterson
1980 Great Western
E M Hay
BMJ VOLUME 319 9 OCTOBER 1999www.bmj.com
The figure shows the progress of patients through the
trial, and table 1 shows the baseline characteristics of
the study sample.
At four weeks, outcome in the injection group was
significantly better than in the naproxen and placebo
groups (table 2). Naproxen showed no advantage over
placebo. Recovery or improvement was reported in 48
patients (92%) in the injection group,30 patients (57%)
in the naproxen group, and 28 patients (50%) in the
Table 3 shows median scores for the Likert scales
for pain, function, and “main complaint” at each follow
up assessment. At four weeks, injection showed a clear
advantage over naproxen and placebo. There were
some small but significant differences in favour of
naproxen or placebo at 6 and 12 months.
The clinical interpretation of these differences was
explored as follows. Comparison between the Likert
scores for pain and participants’ global assessment of
change at four weeks showed that 89% of subjects scor-
ing <3 rated themselves as completely better or
improved; none had got worse. Based on this, outcome
was dichotomised as “better” (pain score <3) or “not
better”(pain score >4).This allowed us to compare the
numbers of patients who had responded to treatment
at each time point (table 4). Overall, 84% of recruited
patients were better at 12 months, and this proportion
was similar for each treatment group (injection 84%,
naproxen 85%, placebo 82%). Some subjects in the
injection group, however, had worsened at six months
but improved again by 12 months.
Details of the self reported presence of elbow pain,
the nurse’s examination findings, and disability scores
are given on the BMJ’s website. Injection was superior
to naproxen and placebo at four weeks; the three
groups were similar at 12 months with a relapse in
some patients in the injection group at six months.
The numbers of patients taking time off paid
employment at four weeks were five (14%) in the injec-
tion group, four (10%) in the naproxen group, and
eight (17%) in the placebo group; the numbers at 12
months were five (14%), four (10%), and 10 (21%),
respectively (P > 0.05 for both times). The numbers of
patients taking painkillers in each group at four weeks
and six and 12 months were similar: 18 (35%), 22
(42%), and 29 (50%) at four weeks; 21 (40%), 19 (36%),
23 (40%) at six months,and 14 (26%),14 (26%),and 16
(28%) at 12 months for injection, naproxen, and
placebo groups respectively.
Case notes were available for 160 participants; four
had transferred practices. In all, 155 records (50 injec-
tion, 52 naproxen, 53 placebo) had information about
the randomised treatment, and 151 records (49
injection, 50 naproxen, 52 placebo) had complete
information concerning patient treatment between the
date of referral and follow up.
significantly between groups during follow up (table 5).
A second injection was received by seven (14%)
patients in the injection group;17 (34%) patients in the
naproxen group and 15 (29%) in the placebo group
Patient did not consent (n=12)
Patient excluded by criteria (n=5)
Not received (n=2)
4 weeks (n=53)
6 months (n=53)
12 months (n=53)
Not received (n=4)
4 weeks (n=53)
6 months (n=53)
12 months (n=53)
Not received (n=2)
4 weeks (n=58)
6 months (n=58)
12 months (n=57)
Patient recruitment, randomisation to treatment group, and follow
Table 1 Baseline characteristics of participants according to
treatment group. Values are numbers (percentages) of
Age (>45 years)
Social class (manual)
Elbow pain today
Pain every day for 1 week
Duration of pain >3 months
Both elbows affected
Belief that current episode was activity induced
Time off work
Long standing medical condition
Medication or pain killers in past 48 hours
Superficially normal joint
Skin atrophy present
Movement and strength
Grip strength >300 mm Hg
Definite pain on resisted extension of middle
Definite pain on resisted extension of wrist
*Percentages may not calculate exactly because of missing data.
BMJ VOLUME 319 9 OCTOBER 1999www.bmj.com
also received an injection during follow up. Fewer
patients in the injection group reconsulted their
randomised intervention, but observed consultation
for tennis elbow pain was similar in all three groups by
Local skin atrophy at the lateral epicondyle was
observed in only two patients at six months and one
patient at 12 months. The three affected patients were
from the naproxen and placebo groups, and only one
had additionally received a local injection. Naproxen
was discontinued in four patients because of gastro-
intestinal side effects. One patient on naproxen had an
allergic reaction characterised by oedema. Pain diaries
recorded for five days after intervention showed a
minor, non-significant, increase in severity of pain after
injection, lasting one day only.
Our results have two important implications for the
management of new episodes of lateral epicondylitis in
general practice. Firstly, a local corticosteroid injection
is an effective, safe initial treatment with a clear clinical
advantage four weeks later compared with a two week
course of naproxen. Naproxen had no advantage over
simple analgesics and a standard advice sheet alone.
Secondly, by 12 months most patients with lateral epi-
condylitis had improved irrespective of initial treat-
ment. Early effective treatment with local steroid
symptoms but did not influence long term outcome.
A small proportion of patients failed to respond to
the initial injection,and some patients who had initially
improved had worse symptoms at six months. These
may be patients whose primary disease lay within the
rapid resolution of
cervical spine or whose local injection was not
accurately placed. We did not give participants specific
instructions about resting or abstaining from work or
sporting activities, and effective pain relief might have
led to a premature return to activity in the injection
group causing a temporary worsening of their
symptoms. Studies of other painful musculoskeletal
syndromes, such as low back pain,12have observed
similar lack of association between early response to
treatment and longer term outcomes. Further research
is required to investigate these issues.
Strengths and weaknesses
The main criticism of previous reviews of treatment for
tennis elbow has been the lack of methodologically
rigorous trials.4 5Our pragmatic study, carried out in a
routine primary care setting, included a relatively
homogeneous population of patients and was suffi-
ciently large to detect clinically important differences
between treatment groups. Possible prognostic vari-
ables were equally distributed between the three treat-
ment groups at baseline. Although patients and
doctors knew which treatment was given, the nurse
who assessed outcome remained unaware of the treat-
ment allocation throughout. Home based assessment
minimised loss to follow up, enabling us to perform a
robust intention to treat analysis.
We recognise a number of limitations to our study.
Firstly, although we aimed to enrol all eligible patients
consulting their general practitioner with a new
episode of tennis elbow during the recruitment period,
Table 2 Outcome at four weeks after invention according to treatment group. Values
are numbers (percentages) of patients
Change in elbow
*P<0.05 compared with naproxen and with placebo.
Table 3 Median (interquartile range) pain and disability self assessment scores
(Likert scale 0-9) in patients with lateral epicondylitis according to treatment group
Time of assessment
Injection Naproxen Placebo
*P<0.05 for injection versus naproxen.
†P<0.05 for injection versus placebo.
‡By area under the curve analysis.
Table 4 Numbers (percentages) of patients with lateral
epicondylitis who were better (pain score <3) at follow up
compared with baseline according to treatment group*
*Percentages may not calculate exactly because of missing data.
†P<0.05 for injection versus naproxen.
‡P<0.05 for injection versus placebo.
Table 5 Numbers (percentages) of patients recorded to have
reconsulted with general practitioner and received
cointerventions during follow up*
*Numbers are cumulative totals during follow up. Percentages may not
calculate exactly because of missing data.
BMJ VOLUME 319 9 OCTOBER 1999 www.bmj.com
the variability in numbers of patients recruited by each Download full-text
general practitioner suggests that some potential
participants were lost at this point. In some of the large
group practices only one or two partners participated.
We do not, therefore, have an accurate knowledge of
the denominator population, making it difficult to use
incidence of tennis elbow in primary care1to estimate
the proportion of all eligible subjects who were
included in the study. However, there were no
differences in participants’ baseline characteristics
between high and low recruiting practices,suggesting a
lack of significant selection bias. By contrast, results
from hospital based studies are difficult to generalise to
primary care.3 5Patients recruited in secondary care
represent an unknown selection of all affected
individuals seen by general practitioners and probably
have more severe, persistent complaints. The median
duration of disease in our patients (nine weeks) was
shorter than in hospital based studies.4 11This indicates
that our study population consisted mainly of patients
with relatively short duration of symptoms,characteris-
tic of those seen in primary care.
Secondly, although standard treatment types and
doses were used, our results apply only to the specific
injection and non-steroidal anti-inflammatory regi-
mens that we used. A two week course of a
practitioners as being in line with current prescribing
practice for a self limiting condition and is the regimen
most commonly used in
condition.10Thirdly, general practitioners taking part
in this study all had previous experience of injecting,13
and care was taken to standardise the injection proce-
dure. Practitioners less skilled in administering soft
tissue injections might not reproduce the positive
results obtained in this study. However, the general
technique was not reviewed, and they were “service”
rheumatology groups or from designated research
Time constraints in primary care make large scale
trials like ours difficult to perform in the context of
every day practice. We involved the general practition-
ers in designing the trial from an early stage to maxim-
ise ownership and commitment.14The protocol was
easy to follow, and use of a research nurse relieved
general practitioners from as much of the paperwork
and data recording as possible. Results from the study
have been fed back to the general practitioners by post
and in practice based workshops. This network of gen-
eral practitioners is currently participating in further
other studies of this
studies of common
We conclude that corticosteroid injections are the
initial treatment of choice for lateral epicondylitis in
primary care if the objective of treatment is to obtain
optimal relief of symptoms during the early weeks.
Patients, however, can be reassured that regardless of
their treatment the probability is high that they will get
better in the longer term. Further research should
determine why some patients do less well after initial
pain relief by injection.
We thank the general practitioners from the Community
Musculoskeletal Research Group (see BMJ’s website for list of
names) for their enthusiasm and hard work. We thank the
Primary Care Rheumatology Society, Professor A Silman, and
Dr P Brennan for help with the study design and early encour-
agement and endorsement; Gill Latham for providing holiday
cover for the study nurse; and Bronwyn Montgomory for
preparing the treatment packages. Finally we thank the patients
who made this project possible.
Contributors: EMH reviewed the literature, prepared the
grant application, contributed to the design of the study, coordi-
nated the study, contributed to the analysis, and acts as guaran-
tor. SMP contributed to the literature review, designed the
questionnaires, performed the patient interviews, contributed to
coordination of the study,and performed most of the data entry.
ML had the main responsibility for data analysis and
contributed to the design and running of the study. GH contrib-
uted to the design of the study.PC contributed to the design and
coordination of the study and supervised the data analysis.EMH
wrote the manuscript, and tables and figures were prepared by
ML. Various drafts were reviewed and revised by all the authors.
Funding:Arthritis Research Campaign.Methylprednisolone
injections were provided by UpJohn and enteric coated
naproxen by Syntex.
Competing interests: None declared.
1 Hamilton PG. The prevalence of humeral epicondylitis: a survey in gen-
eral practice. J R Coll Gen Pract 1986;36:464-5.
Chard MD, Hazleman BL. Tennis elbow—a reappraisal. Br J Rheumatol
Labelle H, Guibert R. Efficacy of diclofenac in lateral epicondylitis of the
elbow alsotreatedwithimmobilization. University
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Labelle H,Guibert R,Joncas J,Newman N,Fallaha M,Rivard CH.Lack of
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Assendelft WJ,Hay EM,Adshead R,Bouter LM.Corticosteroid injections
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11 Matthews JN, Altman DG, Campbell MJ, Royston P. Analysis of serial
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12 Mitchell RI, Carmen GM. Results of a multicenter trial using an intensive
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+ Most lateral epicondylitis is managed by general
practitioners, but optimum treatment is unclear
+ This large pragmatic randomised trial showed
that corticosteroid injection was significantly
better than non-steroidal anti-inflammatories or
placebo tablets at four weeks
+ A two week course of a standard non-steroidal
anti-inflammatory was no better than placebo
+ A few patients who respond well initially to
injection relapse by six months.
+ Long term outcome was good, irrespective of
initial treatment allocation
BMJ VOLUME 319 9 OCTOBER 1999www.bmj.com