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The current study reports a comparison of patients treated with shock waves and manual therapy of the cervical spine with age-matched cases receiving only shock wave therapy SWT in a sin

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of Chronic Tennis Elbow

Introduction

The causes of tennis elbow remain unclear

(Chard and Hazleman 1989, Pienimäki et al

1998) While most authors attribute pain at

the lateral epicondyle to overstrain of the

insertion of the m extensor carpi radialis

bre-vis and consequent local angiofibroblastic

tendinosis (Finestone and Helfenstein 1994,

Foley 1993, Kraushaar and Nirschl 1999,

Roe-tert et al 1995), there are reports suggesting a

reflex chain between intervertebral joint

dys-function and peripherally localized soft-tissue

pain syndromes (Sutter 1995, Waldis 1989,

Wanivenhaus 1986, Wyke 1979) Wright et al

(1994) write that neuronal changes within the

spinal cord might be more important than

peripheral nociceptor sensitization in the

development of chronic musculoskeletal

dis-orders such as tennis elbow This is in

accor-dance with reports of an association between

lateral epicondylitis and a dysfunction in the

cervical spine and at the cervicothoracic

junc-tion in more than 80 % of patients (Ehmer

1998) Cyriax (1982), however, argues that at

the age of 40-60 years it is hightly probably

that any patient suffering from chronic lateral

epicondylitis would have radiographical

evi-dence of cervical spondylosis as well He

denies that pain in the elbow provoked by wrist movements could have the neck as its origin Labelle et al (1992) conclude that con-servative procedures in tennis elbow lacked any scientific basis Boyer and Hastings (1999) also find no conclusive studies on operative and nonoperative treatment concepts New treatment methods have since been undergoing trials The finding that physical stimuli are capable of activating endogenous nociceptive control systems has led to the use

of shock waves in the treatment of persistent tennis elbow (Rompe et al 1996a) Extracor-poreal shock wave therapy (ESWT) was said to fulfill major properties of hyperstimulation analgesia, but the exact mechanism of pain reduction produced by ESWT is still unknown (Melzack 1994) Nevertheless, success rates of

G 50% were achieved in prospective, con-trolled studies on recalcitrant tennis elbow and plantar fasciitis (Heller and Niethard 1998) The current study reports a comparison

of patients treated with shock waves and manual therapy of the cervical spine with age-matched cases receiving only shock wave therapy (SWT) in a single unit (Rompe et al 2001a)

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Fig 6.1 Treatments received before ESWT LA: Local anesthetic.

Materials and Methods

Included in this study were patients

present-ing with chronic lateral epicondylitis of the

elbow in our university hospital

Inclusion Criteria

Inclusion criteria were: pain over the lateral

epicondyle for more than 6 months;

unsuc-cessful conservative therapy during the 6

months prior to referral to our hospital; at least

10 physical therapy visits (electrotherapy,

ion-tophoresis, cryotherapy, or ultrasound) (Fig

6.1); at least three local injections (steroid and/

or local anesthetic) (Fig 6.2); at least two of the

following provocation tests positive: 1

palpa-tion of the lateral epicondyle; 2 resisted wrist

extension (Thomsen test: with the shoulder

flexed to 60°, the elbow extended, the forearm

pronated, and the wrist extended about 30°,

pressure is applied to the dorsum of the second

and third metacarpal bones in the direction of

flexion and ulnar deviation to stress the m

extensor carpi radialis brevis and longus); 3

resisted finger extension (with the shoulder

flexed to 60°, the elbow extended, the forearm

pronated, and the fingers extended the middle

finger is actively extended against resistance);

4 Chair test (with the shoulder flexed to 60°,

and the elbow extended the patient attempts

to lift a chair weighing 3.5 kg); signs of cervical

dysfunction with persistent pressure pain at

the C4/C5 and/or C5/C6 level, protraction posi-tion of the head

Fig 6.2 Atrophy of the skin after multiple

corticoste-roid injections.

6 Extracorporeal Shock Wave Application in the Treatment of Chronic Tennis Elbow

40

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Exclusion Criteria

Exclusion criteria were: age less than 18

years; pregnancy; previous operations on the

lateral epicondyle; previous manual therapy

to the cervical spine; bilateral epicondylitis;

osteoarthritis of the elbow joints;

pathologi-cal, neurologipathologi-cal, and/or vascular findings of

the upper extremity; provocation of pain in

the lateral elbow when examining the cervical

spine; local infection of the upper extremity;

tumorous disease of the upper extremity;

rheumatoid arthritis; coagulopathy; other

treatments or drugs used in the 6 weeks

before the trials began and during the first 3

months after ESWT

Group I

Group I comprised 30 patients suffering from

lateral elbow pain and neck pain All patients

were referred to our shock wave unit for

treat-ment of a recalcitrant epicondylitis These

patients received SWT and manual therapy to

the cervical spine

There were 16 women, 14 men, with a mean

age of 47 years (range: 35–65 years) and a

mean duration of pain of 38 months (range:

12–180 months) There were 27 right-handed individuals; the dominant side was affected in

25 cases A mean of 5.4 ± 1.5 conservative treatment procedures had been carried out without success The patients were not able to work for an average of 4.4 ± 7.2 weeks before the first ESWT

Group II

For each elbow studied, a control matched by age (3-year band) and sex at first conservative treatment was drawn at random from a series

of 146 patients who had undergone a mono-therapy with low-energy shock waves in the same unit in the past 3 years (group II)

There were 16 women and 14 men, with a mean age of 48 years (range: 37–68 years) and

a mean duration of pain of 40 months (range: 12–208 months) There were 26 right-handed patients; the dominant arm was affected in 27 patients An average of 5.5 ± 1.8 unsuccessful conservative therapy procedures had been carried out The mean period of inability to work was 4.5 ± 8.9 weeks before the first ESWT started

Method of Treatment

The ESWT was applied by an easily

maneuver-able therapy unit especially designed for

orthopedic use (Sonocur Plus, Siemens AG,

Erlangen, Germany), with the shock wave

head suspended from an articulating arm for

flexible movement of the head in three planes

The shock wave head was equipped with an

electromagnetic shock wave emitter Shock

wave focus guidance was established by

in-line integration of an ultrasound probe—a

7.5 MHz sector scanner—in the shock head

According to the consensus report (Wess et al

1997) the features of the device, measured

with a fiberoptic hydrophone, are listed in

Table 6.1.

Both groups were treated under the same

conditions and the patients were treated

sin-gly to avoid influencing one another Three times, at weekly intervals, 1000 impulses of 0.16 mJ/mm2

were administered at the ante-rior aspect of the lateral epicondyle at a

fre-quency of 4 Hz (Fig 6.3) No local anesthesia

was applied to the treated area, although the treatment is moderately painful

After the last ESWT, patients from group I were referred to physiotherapists certified for manual therapy who had been instructed to perform soft mobilization therapy of the cer-vical spine and of the cervicothoracic junction

to relieve pain in the C4/C5 and C5/6 motion segments, and to correct the observed pro-traction of the head due to an increased kyphosis of the neck (Butler 1995) Therefore, extension mobilization of the cervicothoracic

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Table 6.1 Fiberoptic data on the shock wave device1

(Minimum value)

Energy level 2 (Mean value)

Energy level 3 (Maximal value)

–6 dB focal extend in x,y,z direction f x (- 6 dB)

f y (- 6 dB)

f z (- 6 dB)

mm mm mm

6.0 6.0 58

5.2 5.2 55

4.8 4.8 49

5 MPa focal extent, lateral f x(5 Mpa)

f y(5 Mpa)

mm mm

2.2 2.2

7.8 7.8

19 19

1

The Sonocur Plus provides eight user-selectable energy levels The physical data listed in the table are typical values for the minimum energy, medium energy, and maximum energy The shock wave param-eters are described according to the consensus meet-ing in February 1997 (Wess et al 1997) All measure-ments were made using a fiberoptic hydrophone.

Fig 6.3 ESWT with the ultrasound-guided Sonocur

Plus device.

Fig 6.4 Mobilization of the cervical spine.

6 Extracorporeal Shock Wave Application in the Treatment of Chronic Tennis Elbow

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Fig 6.5 Evaluation of grip strength with the JAMAR

hand dynamometer.

junction (e.g., Maitland (1991) grade IV)

(Fig 6.4) and flexion mobilization of the high

cervical joints was recommended (e.g.,

Mait-land grade IV) For the intermediate cervical

segments traction and glide movements were

suggested (e.g., Maitland grade II or III minus)

No therapeutic procedures were to be admin-istered to the lateral elbow Ten treatment sessions were held after the last ESWT Follow-ups, by an independent observer, were done 3 months and 12 months after the last application of the extracorporeal shock waves

Method of Evaluation

At all follow-ups the patients were asked

about their pain assessment compared to

pre-treatment conditions The total outcome was

rated following Roles and Maudsley (1972):

—Excellent: No pain, full movement, full

activity;

—Good: Occasional discomfort, full

movement, full activity;

—Acceptable: Some discomfort after

pro-longed activities;

—Poor: Pain limiting activities

The Roles and Maudsley outcome score at the

12-month follow-up was defined as the main

outcome measure The extent of pain was

specified using a Visual Analogue Scale (VAS)

ranging from 0, i.e., no pain, to 10, i.e.,

maxi-mal pain The examination was carried out

independently of the treating physician and

comprised the same four diagnostic tests that

determined entry into the study Additionally,

grip strength was measured bilaterally at the

extended and pronated forearm with a

vigori-meter (Jamar Dynamovigori-meter, Preston

Health-care, Jackson, United States), the pressure

being registered in kp/cm2 Reduction of pain

and grip strength compared to the unaffected

side were regarded as secondary outcome

parameters (Fig 6.5).

Statistics

For statistical analysis, the Wilcoxon–Mann–

Whitney test for two independent samples,

the t-test for the normally distributed

vari-ables of the vigorimeter measures, and the Fisher exact test and its extension to r × c tables were used to compare the two groups Comparison between different examinations were done by means of the Wilcoxon test and t-test, respectively, for dependent samples, and the McNemar test The level of signifi-cance was set at 95 % Tested comparisons with p-values X 5% were considered to be sig-nificantly different

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Table 6.2 Total outcome according to Roles and Maudsley

follow-up

12-month follow-up Group I

(n=30)

Group II (n=30)

Group I (n=30)

Group II (n=30)

Group I (n=27)

Group II (n=25)

Table 6.3 Pain rating on the Visual Analogue Scale (VAS)1

Group I Group II p-value Group I Group II p-value Group I Group II p-value Pressure pain 6.21 ± 2.65 6.15 ± 2.43 0.28 3.99 ± 2.74 3.59 ± 2.29 0.65 2.27 ± 2.59 1.97 ± 2.05 0.82

Thomsen test 6.18 ± 1.72 6.24 ± 1.74 0.60 3.69 ± 2.52 3.86 ± 2.28 0.55 1.93 ± 1.97 2.09 ± 2.01 0.71

Resisted finger

extension

4.62 ± 3.29 4.97 ± 2.84 0.18 2.77 ± 2.29 3.01 ± 3.32 0.58 1.45 ± 1.84 1.66 ± 1.79 0.57

Chair test 5.46 ± 2.11 5.59 ± 2.13 0.54 2.98 ± 2.46 3.00 ± 2.40 0.81 1.91 ± 2.51 1.97 ± 2.27 0.76

1 mean ± standard deviation

Results

There was no difference between the groups

concerning the affected side, sex, age, period

of pain, period of inability to work, and

num-ber of conservative treatment procedures

All the patients were examined at 3 months

Twelve (40 %) patients in group I and 15 (50 %)

patients in group II reached an “Excellent” or

“Good” result Additionally, the patients were

asked to estimate the improvement of pain in

percent, 0 % meaning no relief, 100 % meaning

complete relief of symptoms Mean subjective

improvement of the symptoms was rated at

62 ± 27 % in group I and at 60 ± 34 % in group II

Mean grip strength increased to 91 % of

the unaffected side in group I and to 94 % in

group II

After 12 months we evaluated 27 patients

from group I and 25 from group II At this

point in time we observed 15 (55.5 %)

“Excel-lent” or “Good” results in group I and 15 (60 %)

“Good” or “Excellent” results in group II (Table

6.2) Mean subjective improvement was 75 ±

23 % in group I and 72 ± 33 % in group II Mean

grip strength compared to the contralateral side now amounted to 100 % in group I and to

101 % in group II

The data concerning VAS ratings for 3 months and 12 months are summarized in

Table 6.3 With the numbers available there

was no statistically significant difference between group I and group II concerning the Roles and Maudsley score (extended Fisher test) and the VAS rating (Wilcoxon test for independent samples) Within the two groups there was a highly significant improvement in the VAS and of the Roles and Maudsley out-come score at both follow-ups compared with pretreatment conditions (p X 0.0001)

Additional Treatment

No patient reported additional treatment at the assessment of results at 12 weeks Between 3 and 12 months, three patients in group I and two patients in group II had undergone a release operation In group I two patients required occasional pain medication;

6 Extracorporeal Shock Wave Application in the Treatment of Chronic Tennis Elbow

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Fig 6.6 Hematoma

after low-energy ESWT

of the lateral elbow.

three regularly In group II four patients took

pain medication on a regular basis; three

occasionally With the numbers available

there was no statistically significant

differ-ence between group I and group II with regard

to additional treatment

Complications

Besides petechial bleeding (Fig 6.6), which

occurred in 7 out of 60 patients, no adverse effects were recorded

Discussion

The biological working mechanism of shock

wave application (SWA) is poorly understood

Haake et al (2001) fail to demonstrate any

spi-nal response to low-energy SWA on the

endog-enous opioid systems in rats Schmitz (2001)

reports an investigation on alterations of

neu-ropeptides after applying 1500 shock waves of

an energy flux density of 0.9 mJ/mm2 to the

intact rabbit femur When measuring the

con-centrations of substance P eluated from the

femur periosteum compared to the untreated

contralateral limb, release of substance P had

increased 6 hours and 24 hours after SWA, but

had decreased 6 weeks after SWT Remarkably,

there was a close relationship between the

time course of the release of substance P and

the well-known clinical time course of initial

pain occurrence and subsequent pain relief

after SWA for tendon diseases

According to a review of the literature by Heller and Niethard (1998), the first prospec-tive controlled study on the effecprospec-tiveness of extracorporeal shock waves for the treatment

of chronic tennis elbow was published in

1996 At the 6-month follow-up 48 % “Good”

or “Excellent” outcomes in the treatment group compared to 6 % in the control group were reported according to the Roles and Maudsley score (Rompe et al 1996a) Krischek

et al (1999) prospectively compare the anal-gesic effects of ESWT in patients with recalci-trant lateral or medial epicondylitis With regard to the Verhaar score (Verhaar et al 1993) they report 62 % “Good/Excellent” out-comes in patients with tennis elbow after 1 year compared to 28 % in patients with golfer elbow Perlick et al (1999a) prospectively compare the outcome after ESWT and after

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surgery in 60 patients with chronic tennis

elbow They describe “Good” or “Excellent”

results according to the Roles and Maudsley

score in 43 % and 73 % at the 12-month

follow-up Twenty-three percent versus 10 % of the

patients reported no improvement at all

Haake and Boeddeker (2001) analyze early

results of a prospective placebo-controlled,

double-blinded, multicenter trial on 272

patients Group I was treated three times, at

weekly intervals, with 2000 low-energy

impulses under local anesthesia; group II

received sham therapy After 3 months an

identical successful outcome was observed in

only 25 % of patients in both groups vom Dorp

et al (2001) report preliminary results of 40

out of 114 patients involved in a randomized,

placebo-controlled, double-blinded trial

Three months after three treatments, at

weekly intervals, with 2100 low-energy

impulses without local anesthesia, a

reduc-tion in pain of more than 50 % on the VAS was

observed in 60 % of patients compared with

15 % of patients after placebo therapy

Besides these comparative studies there are

numerous uncontrolled retrospective reports

on the efficacious use of shock waves in the

treatment of tennis elbow (Auersperg 1998,

Boxberg et al 1996, Brunner et al 1997, Göbel

et al 1997, Lohrer et al 1998, Tsironis et al

1997, Wolf and Breitenfelder 1996) As

inclu-sion criteria, treatment procedures, and

out-come measurements were not standardized

the success rates of these studies—58–85 %—

have to be viewed with caution Besides local

hematomas, no shock wave–related

complica-tions have been reported (Sistermann and

Katthagen 1998)

The present study confirmed former results,

leading to “Good/Excellent” results in 56 % and

60 % of the patients at the 1-year follow-up

This is comparable with results after local

cor-ticosteroid injection (Day et al 1978, Verhaar

et al 1996), but in our patients a mean of 2.1

(range: 1–5) steroid infiltrations had led to no

improvement of the symptoms prior to ESWT

Although the procedure is approved by

manual therapists, the quality of the literature

concerning manual therapy of the cervical

spine in the treatment concept of lateral epi-condylitis is poor In a Medline search we found only five matches for cervical spine and tennis elbow between 1976 and 1998 (Wani-venhaus 1986, Waldis 1989, De Marco et al

1998, Gunn and Milbrandt 1976, Vicenzino et

al 1996) This is surprising because following our experience of now more than 160 patients with chronic tennis elbow hardly any patient has no signs of cervical dysfunction such as localized pressure pain at the lower cervical spine, limited range of motion, and protrac-tion of the head Radiologically there were of course signs of cervical spondylarthrosis due

to the age of our patients Patients with neu-rological deficits or pathological conditons of the spinal canal in computed tomography (CT)

or in magnetic resonance imaging (MRI) were excluded from this study

Gunn and Milbrandt (1976) discuss a reflex localization of pain from radiculopathy at the cervical spine in patients with therapy-resistant tennis elbow who had presented with hypomobility of the lower cervical motion segments Maitland (1991) finds that mobilization, traction, isometric exercises and heat, and/or ultrasound, applied to the cervi-cal spine, improved the signs and symptoms

of lateral epicondylitis Maigne (1988) reports complete healing of symptomatic tennis elbow after exclusively manual therapy for the cervical dysfunction in 51 out of 92 patients, and significant improvement in another 29 patients Only two patients required surgery However, inclusion criteria, outcome assessment, and follow-up were not described Huguenin (1988) treated 49 patients with chronic tennis elbow with an ipsilateral cervical segmental dysfunction All patients reported neck pain, an induration of the autochthonous musculature, and limita-tion of the joint play was described The type

of manual treatment applied was not explained No results were specified, never-theless the author stated that his good results documented the connection between seg-mental dysfunction and peripheral muscular symptoms In his opinion a treatment success could not be expected before 4–8 weeks after

6 Extracorporeal Shock Wave Application in the Treatment of Chronic Tennis Elbow

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manual therapy de Branche (1988) analyzed

58 cases with local epicondylalgia and a

cervi-cal spine pathology All the patients received

one to four manipulations of the cervical

spine at weekly intervals In 28.4 % of the

patients a significant improvement was

achieved for 2–4 days; 43.1 % for a longer, not

exactly specified, period Only 15.5 %

remained painfree and were rated a success

The author was not able to establish selection

criteria for manual treatment of the cervical

spine Vincenzino et al (1996) focuses on the

immediacy with which manipulative therapy

may initiate improvement in pain and

func-tion They report a randomized, double blind,

placebo-controlled, repeated measures design

to study the initial effects of a cervical spine

treatment in a group of 15 patients with

lat-eral epicondylitis All the subjects received

treatment, placebo, and control conditions

The treatment condition (contralateral lateral

glide treatment technique for the cervical

spine) produced significant improvement in

the pressure pain threshold, painfree grip

strength, neurodynamics, and pain scores

rel-ative to placebo and control conditions The

authors conclude that manipulative therapy

of the cervical spine is capable of eliciting a

rapid hypoalgesic effect In their opinion

impairment of lateral epicondylagia is

pro-jected from the hypomobile cervical spine

motion segments and that the improvements

gained following application of the

contralat-eral gliding technique result from treating the

source of the referred pain Moreover, mobili-zation of the lower cervical spine is discussed

as being capable of producing a sufficient sen-sory input to recruit and activate descending pain inhibitory systems which exert a portion

or all of the pain relieving effects (Bogduk

1994, Grieve 1994)

In the current study, the focus was on possi-ble additive effects of cervical spine manual therapy on patients treated with ESWT for chronic tennis elbow With the numbers avail-able we failed to demonstrate a positive effect

of a standardized manual therapy to the cervi-cal spine Though, statisticervi-cally, our treatment groups did not differ with regard to epidemio-logical data, it must be made clear that the patients for both procedures were not ran-domized, therefore selection and information bias cannot be ruled out

Our data underline the value of low-energy ESWT in chronic lateral epicondylalgia and question the usefulness of additional cervical spine manual treatment in these patients Fur-ther studies are mandatory to establish the optimum treatment regime with ESWT for patients with recalcitrant tennis elbow and to clarify what role manual therapy of the cervi-cal spine may play in the treatment of this enthesiopathy The mechanisms by which ESWT or cervical spine manual therapy achieve improvements in pain and function are yet to be elucidated and must form the basis for ongoing research

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