81

ORIGINAL ARTICLE

A controlled clinical pilot trial to study the effectiveness of ice

Background: The use of ice as a supplement to an exercise programme has been recommended for the
management of lateral elbow tendinopathy (LET). No studies have examined its effectiveness.
Objectives: To investigate whether an exercise programme supplemented with ice is more successful than
the exercise programme alone in treating patients with LET.
Methods: Patients with unilateral LET for at least four weeks were included in this pilot study. They were
sequentially allocated to receive five times a week for four weeks either an exercise programme with ice or
the exercise programme alone. The exercise programme consisted of slow progressive eccentric exercises
See end of article for
of wrist extensors and static stretching of the extensor carpi radialis brevis tendon. In the exercise
authors’ affiliations programme/ice group, the ice was applied after the exercise programme for 10 minutes in the form of an
....................... ice bag to the facet of the lateral epicondyle. Patients were evaluated at baseline, at the end of treatment,
Correspondence to: and three months after the end of treatment. Outcome measures used were the pain visual analogue scale
D Stasinopoulos, School of and the dropout rate.
Health and Human Results: Forty patients met the inclusion criteria. At the end of treatment there was a decline in visual
Sciences, Faculty of Health, analogue scale of about 7 units in both groups compared with baseline (p,0.0005, paired t test). There
Leeds Metropolitan
University, Calverly St, were no significant differences in the magnitude of reduction between the groups at the end of treatment
Leeds LSI 3HE, UK; and at the three month follow up (p,0.0005, independent t test). There were no dropouts.
d_stasinopoulos@ Conclusions: An exercise programme consisting of eccentric and static stretching exercises had reduced
yahoo.gr
the pain in patients with LET at the end of the treatment and at the follow up whether or not ice was
Accepted 23 May 2005 included. Further research to establish the relative, absolute, and cost effectiveness as well as the
....................... mechanism of action of the exercise programme is needed.

L
ateral elbow tendinopathy (LET) commonly referred to as but all have the same aim, to reduce pain and improve
lateral epicondylitis and/or tennis elbow, is one of the function. Such a variety of treatment options suggests that
most common lesions of the arm. The origin of the the optimal treatment strategy is not known, and more
extensor carpi radialis brevis (ECRB) is the most commonly research is needed to discover the most effective treatment in
affected structure.1 LET is usually defined as a syndrome of patients with LET.
pain in the area of the lateral epicondyle2–4 and is a One of the most common physiotherapy treatments for
degenerative or failed healing tendon response characterised LET is an exercise programme.10 12 13 One consisting of
by the increased presence of fibroblasts, vascular hyperplasia, eccentric and static stretching exercises has shown good
increased amounts of proteoglycans and glycosaminoglycans, clinical results in LET18 as well as in conditions similar to LET
and disorganised collagen.1 4 It is generally a work related or in clinical behaviour and histopathological appearance, such
sport related pain disorder usually caused by excessive quick, as patellar19 20 and Achilles 21–26 tendinopathy. Such an
monotonous, repetitive motions of the wrist.5 The dominant exercise programme is used as the first treatment option for
arm is commonly affected, with a prevalence of 1–3% in the our patients.27 Some clinicians recommend the use of ice for
general population.6 The peak prevalence of LET is between 10–15 minutes as a supplement to the exercise pro-
30 and 60 years.4 7 The disorder appears to be of longer gramme.28 29 To our knowledge, there have been no studies
duration and severity in women.4 7 8 of the latter. The aim of this study was to compare the clinical
The main symptoms are pain and decreased function, both results of the use of ice after the exercise programme with
of which may affect activities of daily living. Diagnosis can be those of the exercise programme alone in patients with LET.
confirmed by tests that reproduce the pain, such as palpation
over the facet of the lateral epicondyle, resisted wrist MATERIALS AND METHODS
extension, resisted middle finger extension, and passive wrist A controlled, monocentre trial was conducted in a clinical
flexion.3 setting over 21 months to assess the effectiveness of an
However, no ideal treatment has emerged for the manage- exercise programme alone or with ice in patients with LET. A
ment of LET. Many clinicians advocate a conservative parallel group design was used because crossover designs are
approach as the choice of treatment for LET.9–12 limited in situations where patients are cured by the
Physiotherapy is a conservative treatment that is usually intervention and do not have the opportunity to receive the
recommended.11 13 14 A wide array of physiotherapy treat- other treatments after crossover.30 One investigator (PM)
ments has been recommended for the management of LET administered the treatments, evaluated the patients to
such as electrotherapeutic modalities, exercise programmes,
soft tissue manipulation, and manual techniques.11 15–17 These Abbreviations: ECRB, extensor carpi radialis brevis; LET, lateral elbow
treatments have different theoretical mechanisms of action, tendinopathy; VAS, visual analogue scale

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82 Dimitrios, Manias

confirm the LET diagnosis, performed all baseline and follow patient’s tolerance. This position was held for 30–45 seconds
up assessments, and obtained informed consent. each time and then released. The exercise programme was
Patients over 18 years old with lateral elbow pain were given five times a week for four weeks and was individualised
examined and evaluated in a private outpatient physiother- on the basis of the patient’s description of pain experienced
apy clinic in Ithaki between January 2003 and June 2004. All during the procedure. In the exercise programme/ice group,
patients lived in Ithaki, Greece, were native Greek speakers, the ice was applied after the exercise programme for
and were either self referred or referred by their doctor or 10 minutes in the form of an ice bag to the painful area
physiotherapist. (facet of lateral epicondyle).
Patients were included in the study if, at the time of Pain and dropout rate were measured in this study. Each
presentation, they had been evaluated as having clinically patient was evaluated at the baseline (week 0), at the end of
diagnosed LET for at least four weeks. Patients were included treatment (week 4), and three months (week 16) after the
in the trial if they reported (a) pain on the facet of the lateral end of treatment in order to see the intermediate effects of
epicondyle when palpated, (b) less pain during resistance the treatments.
supination with the elbow in 90˚ of flexion rather than in full Pain was measured on a visual analogue scale (VAS),
extension,1 and (c) pain in at least two of the following four where 0 (cm) was ‘‘least pain imaginable’’ and 10 (cm) was
tests:3 ‘‘worst pain imaginable’’. The pain VAS was used to measure
the patient’s worst level of pain over the 24 hours before each
1. Tomsen test evaluation, and this approach has been shown to be valid and
2. Resisted middle finger test sensitive.32
3. Mill’s test The dropout rate was also used as an indicator of treatment
4. Handgrip dynamometer test outcome. Dropouts were categorised as follows: (a) with-
drawal without reason; (b) did not return for follow up; (c)
Patients were excluded from the study if they had one or request for an alternative treatment.
more of the following conditions: (a) dysfunction in the The change from baseline was calculated for each follow
shoulder, neck and/or thoracic region; (b) local or generalised up. Differences between groups were determined using the
arthritis; (c) neurological deficit; (d) radial nerve entrapment; independent t test. The difference within groups between
(e) limitations in arm functions; (f) the affected elbow had baseline and end of treatment was analysed with a paired t
been operated on; (g) had received any conservative treat- test. A 5% level of probability was adopted as the level for
ment for the management of LET in the four weeks before statistical significance. SPSS 11.5 statistical software was
entering the study.3 5 31 used for the statistical analysis.
All patients received a written explanation of the trial
before entry into the study and then gave signed consent to
RESULTS
participate. They were allocated to two groups by sequential
Sixty two patients eligible for inclusion visited the clinic
allocation. For example, the first patient with LET was
within the trial period. Twelve were unwilling to participate
assigned to the exercise programme/ice group, the second
in the study, and 10 did not meet the inclusion criteria
patient with LET to the exercise programme alone group, and
so on.
All patients were instructed to use their arm during the All LET patients presenting to the clinic
course of the study but to avoid activities that irritated the (n = 62)
elbow such as shaking hands, grasping, lifting, knitting,
handwriting, driving a car, and using a screwdriver. They Unwillingness
were also told to refrain from taking anti-inflammatory drugs (n = 12)
throughout the course of study. Patient compliance with this
request was monitored using a treatment diary. Potential participants
The exercise programme consisted of slow progressive (n = 50)
eccentric exercises of the wrist extensors and static stretching
exercises of the ECRB tendon. Three sets of 10 repetitions of
slow progressive eccentric exercises of the wrist extensors at Inclusion criteria
each treatment session were performed, with one minute rest
interval between each set. Static stretching exercises of the
ECRB tendon were repeated six times at each treatment Not meeting inclusion
session, three times before and three times after the eccentric criteria (n = 10)
exercises, with a 30 second rest interval between each
repetition. Eccentric exercises of the wrist extensors were Eligible patients
performed with the elbow on the bed in full extension, the (n = 40)
forearm in pronation, the wrist in an extended position (as
high as possible), and the hand hanging over the edge of the
bed. From this position, patients flexed their wrist slowly Sequential allocation
while counting to 30, then returned to the starting position (n = 40)
with the help of the other hand. Patients were told to
continue with the exercise even if they experienced mild
pain. However, they were told to stop the exercise if the pain Exercise programme Exercise programme
became disabling. When patients were able to perform the with ice (n = 20) (n = 20)
eccentric exercises without experiencing any minor pain or
discomfort, the load was increased using free weights. Static
stretching exercises of the ECRB tendon were performed with Completed trial Completed trial
the help of the therapist (PM). The therapist placed the elbow (n = 20) (n = 20)
of the patient in full extension, the forearm in full pronation,
and the wrist in flexion and ulnar deviation according to the Figure 1 Flow chart of the study.

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Ice for lateral elbow tendinopathy 83

Table 1 Previous treatments of participants Table 3 Change in pain over the 24 hours before each
evaluation from baseline
Exercise Exercise
programme and ice programme Exercise Exercise
programme and ice programme p Value
Drugs 12 (60) 11 (55)
Physiotherapy 4 (20) 4 (20) Week 4 26.90 26.90 .0.0005
Injection 4 (20) 5 (25) Week 16 27.10 27.10 .0.0005

Values are number (%). Values are mean visual analogue scores where 0 = least pain
imaginable and 10 = worst pain imaginable. p Values for independent t
test on change in VAS from baseline are shown.
described above. The other 40 patients were sequentially
allocated to one of the two possible groups: (a) exercise
programme and ice (n = 20; seven men, 13 women; mean Eccentric exercises were performed at a low speed in every
(SD) age 43.14 (6.15) years); (b) exercise programme alone treatment session because this allows tissue healing.1 21
(n = 20; six men, 14 women; mean (SD) age 42.57 Exercise programmes appear to reduce the pain and
(6.31) years). Patient flow through the trial is summarised improve function, reversing the pathology of LET,36–39 as
in a CONSORT flow chart (fig 1). supported by experimental studies on animals.40 The way that
At baseline there were more women in the groups (14 more an exercise programme achieves the goals remains uncertain
in total). The mean age of the patients was about 40 years, as there is a lack of good quality evidence to confirm that
and the duration of LET was about four months. LET was in physiological effects translate into clinically meaningful
the dominant arm in 85% of patients. There were no outcomes and vice versa.
significant differences in mean age (p.0.0005, independent There are two types of exercise programme: home exercise
t test) or the mean duration of symptoms (p.0.0005, programmes and exercise programmes carried out in a
independent t test) between the groups. Patients had received clinical setting. A home exercise programme is commonly
a wide range of previous treatments (table 1). Drug therapy advocated for patients with tendinopathies such as LET
had been tried by 55%. All patients were manual workers. because it can be performed any time during the day without
Baseline pain on VAS was 8.70 (95% confidence interval requiring supervision from a physiotherapist. Our clinical
8.42 to 8.98) for the whole sample (n = 40) (table 2). There experience, however, has shown that patients fail to comply
were no significant differences between the groups for with the regimen of home exercise programmes.27 This
baseline pain (p.0.05 independent t test; table 2). At week problem can be solved by exercise programmes performed
4 there was a decline in VAS of about 7 units in both groups in a clinical setting under the supervision of a physiothera-
compared with the baseline (p,0.0005, paired t test; table 3). pist. For the purposes of this report, ‘‘supervised exercise
There were no significant differences in the magnitude of programme’’ will refer to such programmes.
reduction between the groups at week 4 and week 16 This exercise programme has been used in previous clinical
(p,0.0005 independent t test; table 3). trials on LET.18 31 41–46 However, it was the sole treatment in
There were no dropouts and all patients successfully only two previous trials.18 31 A home exercise programme was
completed the study. the sole treatment in one of these two,31 and was
administered in a totally different manner from the
supervised exercise programme used in the present controlled
DISCUSSION clinical trial and the study of Stasinopoulos et al.18 The
The results obtained from this pilot trial are novel, as to date differences were not only in the environment in which the
there have been no data comparing the effectiveness of an exercise programmes were administered, but also in the
exercise programme with ice and an exercise programme development of the treatment protocol (type of exercises,
alone for the reduction of pain in LET. intensity, frequency, duration of treatment). There is clearly a
The ice may decrease the extravasation of blood and need for a clinical trial that would compare the effects of the
protein from new capillaries found in tendinopathy as well as supervised exercise programme treatment protocol, consist-
decreasing the metabolic rate of the tendon.33 Both mechan- ing of eccentric and static stretching exercises, with the home
isms promote healing of LET. In addition, ice can be used for exercise programme treatment protocol used by Pienimaki et
symptomatic relief of pain. However, the findings of this trial al.31
indicate that ice as a supplement to the exercise programme Previous trials have found that a home exercise programme
offers no benefit in patients with LET. Therefore the reduced the pain in patellar19 20 and Achilles 21–26 tendino-
reduction in pain at the end of the treatment and at the pathy. However, it was performed for about three months in
follow up was due to the exercise programme consisting of all previous studies. In contrast, in the present controlled
eccentric and static stretching exercises. clinical trial and the studies of Stasinopoulos and collea-
Standard eccentric exercises offer adequate rehabilitation gues,18 20 a supervised exercise programme was administered
for tendon disorders, but many patients with tendinopathies for a month. Thus it seems that the supervised exercise
do not respond to this prescription alone.34 The load of programme may give good long term clinical results in a
eccentric exercises was increased according to the patients’ shorter period of time than the home exercise programme.
symptoms because the opposite has shown poor results.35 The most likely explanation for this difference is that a

Table 2 Pain over the 24 hours before each evaluation

Exercise programme and ice 8.60 (8.22 to 8.98) 1.70 (0.99 to 2.41) 1.50 (0.94 to 2.06)
Exercise programme 8.80 (8.35 to 9.25) 1.90 (1.08 to 2.72) 1.60 (0.83 to 2.37)

Values are mean (95% confidence interval) visual analogue scores where 0 = least pain imaginable and 10 =
worst pain imaginable.

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84 Dimitrios, Manias

.....................
Authors’ affiliations
What is already known on this topic D Stasinopoulos, School of Health and Human Sciences, Faculty of
Health, Leeds Metropolitan University, Leeds, UK
N Many clinicians use ice as a supplement to an exercise P Manias, Private Clinic, Ithaki 28300, Greece
programme consisting of eccentric and static stretching Competing interests: none declared
exercises for the management of lateral elbow This paper was presented at the 10th Symposium in Lixouri, Kefalonia
tendinopathy entitled Athletic exercise doping, 3 September 2005.

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