Subido por Verónica Sánchez Espíritu

A prospective randomized study comparing

J Shoulder Elbow Surg (2010) 19, 508-512
A prospective randomized study comparing a forearm
strap brace versus a wrist splint for the treatment
of lateral epicondylitis
Rishi Garg, MDa, Gregory J. Adamson, MDb,*, Patrick A. Dawson, MDb,
James A. Shankwiler, MDb, Marilyn M. Pink, PhDb
West Coast Orthopaedics, Arcadia, CA
Congress Medical Associates, Pasadena, CA
Background: The outcome is unknown for 2 common bracing treatments utilized for patients with lateral
epicondylitis. The purpose of this study was to compare the clinical outcomes of a wrist splint with that of
a counterforce forearm strap for the management of acute lateral epicondylitis.
Materials and methods: Forty-two patients (44 elbows) received either a wrist extension splint (Group I24 elbows) or a counterforce forearm strap (Group II-20 elbows). Measures on the Mayo Elbow Performance (MEP) and American Shoulder and Elbow Society (ASES) Elbow Assessment Form were collected
prior to treatment and at 6 weeks. A total score was derived, utilizing the ASES Elbow Assessment, as was
a score utilizing the standard scoring system for the MEP.
Results: Group I’s score derived from the ASES form improved 16 points and Group II’s score improved
13 points. Group I’s score on the MEP improved 13 points and Group II’s score improved 12 points. There
was no significant difference measured between the Groups with the ASES (P ¼ .60) nor MEP (P ¼ .63)
scores. However, within the ASES derived score, pain relief was significantly better with the extension
splint group (P ¼ .027). No other variables were statistically significantly different.
Discussion: Significant pain relief with the wrist extension splint may be due to improved immobilization
of the wrist extensor muscles in a resting position.
Conclusion: The wrist extension splint allows a greater degree of pain relief than does the forearm strap
brace for patients with lateral epicondylitis.
Level of evidence: Level II, Randomized Control Study, Lesser Follow-Up, Treatment Study.
Ó 2010 Journal of Shoulder and Elbow Surgery Board of Trustees.
Keywords: Elbow; lateral epicondylitis; forearm strap brace; wrist splint
With a reported annual incidence of 1% to 3% in the
general population, lateral epicondylitis, or ‘‘tennis elbow,’’
is the most common cause of lateral elbow pain.5
The authors received IRB approval #HMH04-37 at our institution Huntington Memorial Hospital.
*Reprint requests: Gregory J. Adamson, MD, Congress Medical
Associates, 800 S Raymond Ave., 2nd Floor, Pasadena, CA 91105.
E-mail address: [email protected] (G.J. Adamson).
Somewhat of a misnomer, ‘‘tennis elbow’’ actually occurs
in fewer than 5% to 10% of tennis players.2,6 Lateral epicondylitis, like most other tendinopathies, typically occurs
during the 4th and 5th decades of life. It is caused by
inflammation of the common extensor origin on the lateral
epicondyle of the humerus, with resultant microtears and
histologic changes of angiofibroblastic hyperplasia.15 The
extensor carpi radialis brevis (ECRB) and the extensor
1058-2746/2010/$36.00 - see front matter Ó 2010 Journal of Shoulder and Elbow Surgery Board of Trustees.
Lateral epicondylitis: brace vs splint
digitorum communis (EDC) have been implicated as the
most commonly affected tendons. Symptoms of lateral
elbow pain, aggravated by active wrist extension, supination, and power grip are common. Conservative treatment
strategies have been directed at relieving inflammation
through rest, icing, activity modifications, NSAIDs, splints,
injections, and, more recently, extracorporeal shock wave
therapy. Nonoperative treatment of lateral epicondylitis is
successful in 70-80% of cases at 1 year.4
Two popular methods of bracing include a forearm
counterforce strap and a wrist extension splint. The forearm
counterforce strap is placed around the muscle bellies of the
wrist extensors just distal to the elbow, while an extension
splint is placed on the wrist. The orthopaedic literature is
lacking in studies directly comparing the efficacy of wrist
splinting with forearm counterforce strap bracing for this
condition. The purpose of our study was to compare the
clinical outcome of a wrist splint with a forearm counterforce
strap brace for the management of acute lateral epicondylitis.
Figure 1
Hely and Weber wrist extension splint.
Materials and methods
This prospective randomized investigation was approved by the
Institutional Review Board at our institution prior to enrollment of
patients. Between 2005 and 2008, 509 consecutive patients presenting to our office with symptoms of acute lateral epicondylitis
were evaluated for inclusion in the study. Patients were included if
they met the diagnostic criteria of lateral sided elbow pain,
tenderness to palpation over the lateral extensor origin, and pain
with resisted wrist and long finger extension. Those who had
received prior treatments such as physical therapy, bracing, or
steroid injections within the last 6 months were excluded. Additionally, patients with cervical radiculitis or compressive neuropathies in the involved extremity were excluded. Standard
anteroposterior and lateral radiographs were obtained to further
assure that patients did not have alternate causes of elbow pain.
Patients were excluded if radiographs were positive for arthritis or
other pathology. A minimum 6-week follow-up was required.
A total of 70 patients (74 elbows) met the criteria; however, 25
patients were lost to follow-up and 3 did not complete outcome
measurement forms. Thus 42 patients (44 elbows) were randomized into 1 of 2 treatment groups.
Group I received the Hely & Weber (Santa Paula, CA) Velcro
wrist extension splint (Figure 1). This group consisted of 24
patients (24 elbows), of which 15 were female and 9 were male,
with an average age of 51.8 years 7.9. The majority of patients
were right-hand dominant (83%), and the dominant elbow was
involved 79% of the time.
Group II received the Hely & Weber forearm counterforce strap
brace (Figure 2). This group consisted of 18 patients (20 elbows), of
which 7 were female and 11 were male, with an average age of 53.1
years 11. The majority of patients were right-hand dominant
(89%), and the dominant elbow was involved 55% of the time.
Upon assignment of the brace, patients were sent to a single
certified orthotist for brace application. Patients were instructed to
wear the brace during all daytime hours for a period of 6 weeks. In
addition to bracing, patients were given standardized instructions in
icing and home stretching exercises. Brace removal was allowed
Figure 2
Hely and Weber forearm strap brace.
only for bathing, sleeping, and during performance of stretching
exercises. Analgesics and anti-inflammatory medications were not
formally prescribed for the patients during the study period;
however, patients were allowed to take occasional over the counter
nonsteroidal anti-inflammatory drugs (NSAIDs) as needed.
In addition to a history and physical examination, clinical
outcomes were measured using the American Shoulder and Elbow
Society (ASES) Elbow Assessment Form10 and the Mayo Elbow
Performance (MEP).14 Clinical outcomes were measured at the
time of enrollment, as well as at the 6-week follow-up. A 3-week
interval visit was also scheduled to track patient progress and
check for compliance with the treatment protocol.
The score derived from the ASES Elbow Assessment form
(henceforward called the ASES derived score) was calculated
using a formula based on the variables that did not produce
a ceiling effect.13 These variables included pain at its worst,
ability to carry a heavy object, and ability to perform heavy
household chores. The derived score formula was conceptually
similar to that of the ASES Shoulder Score Index.16 The
maximum total score is 100 points, with half the points derived
from pain and half the points from function. The pain scale is
a 10-point analogue pain scale. Each functional variable outcome
consists of 4 choices in an ordinal scale.
The MEP score was calculated as per prior publication.14 The
maximum total score is 100 points. Pain is weighted as 45% of the
score, ROM as 20%, stability as 10%, and ADL as 25%. The pain
variable outcome consists of a 4-choice ordinal scale, ROM and
stability are each a 3-choice ordinal scale, and the 5 functional
activities are a dichotomous (can do/cannot do) scale.
A change score for each variable and each total score was
calculated by subtracting the pre-treatment scores from the 6week follow-up scores. A post-hoc power analysis was performed
to determine if sufficient sample size was obtained to achieve 80%
power to detect a 20% difference in mean.
The data were treated as parametric for the analog pain scale
within the ASES Elbow Assessment and as non-parametric for any
variable with 4 or less ordinal outcome choices. Likewise, the
derived ASES Score and the MEP Score were treated as
nonparametric, as at least half the score consisted of nonparametric components. Independent t tests compared the change
scores of each outcome variable and the derived scores for the 2
splint conditions (P < .05).
R. Garg et al.
Figure 3 American Shoulder and Elbow Society score before
and 6 weeks after treatment.
Power, in each group, was minimally 80%. In Group I, the
mean ASES score prior to treatment was 35.2 16.9, and
at 6 weeks post-treatment was 51.1 19.0 (Figure 3). In
Group II, the mean ASES score prior to treatment was 40.7
25.2, and at 6 weeks post-treatment was 54.3 16.6.
Although both groups improved, the difference between the
2 groups was not significant (P ¼ .60). In evaluating the
individual components of the ASES score, patients in
Group I reduced their pain at worst score from 7.5 1.8 to
5.8 2.0 at 6 weeks, while patients in Group II reduced
this score from 6.7 2.7 to 6.4 2.6 (Figure 4). This
difference was significant (P ¼ .027), demonstrating the
wrist extension splint group had better pain relief. The
score for carrying heavy objects in Group I increased from
1.4 0.7 to 1.7 0.7 at 6 weeks, while for Group II the
score increased from 1.3 0.9 to 2.1 0.6 (Figure 5). This
difference was not significant (P ¼ .06). The score for
ability to perform heavy chores increased from 1.4 0.8 to
1.9 0.8 in Group I at 6 weeks and increased from 1.6 0.8 to 2.3 0.6 in Group II (Figure 6). This difference was
not significant (P ¼ .59).
Both groups improved their MEP Scores, with Group I
increasing from 70.8 7.9 to 83.5 9.8 at 6 weeks and
Group II increasing from 69.8 10.9 to 81.3 9.6 (Figure 7).
The difference between the 2 groups’ improvement was not
significant (P ¼ .63). All patients in both groups had full
range of motion and stability before and after treatment.
There are several reasons why the extension splint group
had significantly better pain relief. One possible theory
explaining this finding is that the wrist splint allows
Figure 4 Pain at worst score before and 6 weeks after treatment
as part of the ASES score with low numbers ¼ less pain.
improved immobilization of the wrist extensors in the
resting position. Jansen et al9 investigated the amount of
electrical activity in the wrist extensors by electromyography during activity with and without the wrist splint. The
authors discovered a significant decrease in electrical
activity using the splint during lifting activities compared to
no splint and, therefore, assumed there was decreased
tension on the tendon. Additionally, the wrist extension
splint is generally visible and serves as a constant reminder
to avoid using that arm, possibly allowing better pain relief
than the forearm strap. Furthermore, the wrist splint
prevents passive stretching of the extensor tendons, thus
contributing to pain relief, while the forearm strap does not.
Counterforce strap bracing was introduced by Ilfeld in
1965, but Nirschl coined the term ‘‘counterforce’’ in
reference to a nonelastic strap to prevent full muscular
expansion of the proximal forearm.8,15 The therapeutic
effect of this brace lies in the compressive force applied just
distal to the origin of the ECRB, which acts to reduce force
transmission across the inflamed portion of the muscle
tendon unit. Meyer et al12 performed a combined cadaveric
and clinical study showing a 13-15% force reduction of the
ECRB origin. Snyder-Mackler and Epler18 demonstrated
a statistically significant decrease in ECRB and EDC
Lateral epicondylitis: brace vs splint
Figure 5 Ability to carry heavy objects score before and 6
weeks after treatment as part of the ASES score.
Figure 6 Ability to perform heavy chores score before and 6
weeks after treatment as part of the ASES score.
muscle force recruitment with the counterforce strap, when
compared to no strap, as measured by electromyography.
By inhibiting muscle expansion, the strap decreases the
magnitude of muscle contraction and, therefore, reduces
tension at the musculotendinous junction proximal to the
band. Furthermore, the direct compression provided by the
strap creates a secondary origin of the extensor tendons;
therefore, unloading the true origin at the lateral
Although better pain relief was discovered in the wrist
splint group, there was no functional difference between the
2 groups. This explains why the total ASES and MEP
scores were not significantly different. The high functioning level diluted the pain to an almost undetectable
difference. Altan and Kanat1 performed a similar randomized prospective study and concluded there was no significant difference between the 2 brace groups at 6 weeks. The
extension splint did not provide improved pain relief over
the strap. However, the authors used different outcome
measurements than this study. For example, pain was
measured during rest and movement rather than specifying
pain at worst. In addition, ability to perform daily activities
was not evaluated. Their patient population differed from
this study as well, possibly explaining the difference in
Figure 7 Mayo Elbow Performance score before and 6 weeks
after treatment.
results. In another similar study, Van de Streek et al21 also
concluded there was no difference between the 2 groups at
6 weeks. Their primary outcome measurement was grip
strength and pain with grip, as opposed to activities of daily
living and pain at worst, therefore explaining the difference
in results from this study.
Although braces are commonly prescribed for lateral
epicondylitis, there is some question regarding their effectiveness. Wuori et al22 compared a counterforce strap with
a simple elbow support sleeve, placebo brace, and no brace,
and found no significant difference in both grip strength
and pain between the groups. However, pain was measured
during gripping activities and not subjectively by questionnaire; thus average pain scores were between 1 and 3 on
a visual analog scale, while, in this study, pain scores were
much higher. Derebery et al7 performed a retrospective
study on injured workers with epicondylitis to compare
patients who received extension splints to those who did
not. Significant findings included patients with splints had
higher rates of limited duty, more medical visits and
charges, higher total charges, and longer treatment durations than patients without splints. However, the authors
included medial epicondylitis in the study group and did
not control for concurrent treatments, such as medication or
therapy due to the retrospective study design. Additionally,
there were several baseline differences between the groups
that received the brace from the group that did not. Patients
with higher pain severity ratings were more likely to
receive the brace.
Several studies have compared bracing to other treatment
modalities, and there is a lack of evidence for the long-term
benefit of physical interventions in general.3 In a randomized
controlled trial, Struijs et al19 evaluated the clinical outcome
and cost-effectiveness of 180 patients receiving either
therapy, elbow strap bracing, or a combination of both for the
treatment of lateral epicondylitis at a minimum 1-year
follow-up. No clinically relevant or statistically significant
differences were found between the groups in regard to pain
and function. Success rate at 12 months was 89% in the
physical therapy group, 86% in the brace group, and 87% in
the combination group. The same authors performed a metaanalysis that included all randomized clinical trials
describing individuals with diagnosed lateral epicondylitis
and comparing the use of an orthotic device as a treatment
strategy.20 Only 5 studies met their inclusion criteria;
therefore, there were few outcome measures, large heterogeneity, and limited long-term results. They stated no
definitive conclusions could be drawn concerning the
effectiveness of orthotic devices and that more well-designed
randomized clinical trials of sufficient power are warranted.
Labelle et al11 performed a systematic review to assess the
scientific evidence for methods of treatment for lateral epicondylitis. The authors concluded that there was insufficient
evidence to support any of the current conservative treatment
options, secondary to lack of scientific validity.
Several limitations to this study existed, including the
lack of a control group whom received no treatment. Smidt
et al17 showed patients who did not receive any treatment
had similar success rates at 1 year compared to other
treatment modalities, although they did significantly worse
in the short term. The study reported herein did not focus
on whether the brace groups improved individually versus
no treatment, but rather compared the differences in clinical
outcome between the 2 types of braces.
Another limitation of this study is that occasional
NSAID use was allowed if pain was intolerable. This
potentially adds a confounding variable, although it was
assumed each group had equal amounts of NSAID usage.
The last limitation is the lack of long-term follow-up. The
follow-up interval was purposefully chosen to determine
the acute clinical outcome differences between the 2 brace
groups at 6 weeks rather than long-term differences.
There was no difference in total clinical outcome scores
between the forearm counterforce strap and the extension wrist splint groups for the treatment of lateral epicondylitis of the elbow at 6 weeks. However, the
extension splint group had significantly better pain relief
and thus is recommended over the forearm strap brace.
The authors, their immediate families, and any research
foundations with which they are affiliated have not
received any financial payments or other benefits from any
commercial entity related to the subject of this article.
R. Garg et al.
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