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2004; 84:336-343.PHYS THER. Dinçer and Geert JMG van der HeijdenYesim Kurtais Gürsel, Yasemin Ulus, Ayse Bilgiç, GülayPlacebo-Controlled TrialDisorders of the Shoulder: A Randomized Adding Ultrasound in the Management of Soft Tissue

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Adding Ultrasound in theManagement of Soft Tissue Disordersof the Shoulder: A RandomizedPlacebo-Controlled Trial

Background and Purpose. There is still a lack of evidence about thebeneficial effects of ultrasound (US) intervention for the managementof soft tissue problems. Thus, this study was designed to assess theeffectiveness of US over a placebo intervention when added to otherphysical therapy interventions and exercise in the management ofshoulder disorders. Subjects and Methods. Forty patients who werediagnosed by ultrasonography or magnetic resonance imaging to havea periarticular soft tissue disorder of the shoulder were randomlyassigned to either a group that received true US (n�20; mean timesince onset of pain�8.7 months, SD�8.8, range�1–36) or a group thatreceived sham US (n�20; mean time since onset of pain�8.1 months,SD�10.8, range�1– 42). Besides true or sham US (10 minutes),superficial heat (10 minutes), electrical stimulation (15 minutes), andan exercise program (15–30 minutes) were administered to bothgroups 5 days each week for 3 weeks. Results. Subjects showedwithin-group improvements in pain, range of motion, Shoulder Dis-ability Questionnaire scores, and Health Assessment Questionnairescores with the intervention, but the differences did not reach signif-icance when compared between the groups. Discussion and Conclu-sion. The results suggest that true US, compared with sham US, bringsno further benefit when applied in addition to other physical therapyinterventions in the management of soft tissue disorders of theshoulder. [Kurtaiş Gürsel Y, Ulus Y, Bilgiç A, et al. Adding ultrasoundin the management of soft tissue disorders of the shoulder: a random-ized placebo-controlled trial. Phys Ther. 2004;84:336 –343.]

Key Words: Physical therapy, Randomized clinical trial, Shoulder, Soft tissue disorders, Ultrasound.

Yeşim Kurtaiş Gürsel, Yasemin Ulus, Ayşe Bilgiç, Gülay Dinçer, Geert JMG van der Heijden

336 Physical Therapy . Volume 84 . Number 4 . April 2004

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Shoulder pain is a major reason that patientsseek consultations with physicians. Pain restrictsshoulder motion and limits daily activities, caus-ing disability.1,2 In general, soft tissue impair-

ments and pathologies such as inflammation of thetendons and bursae surrounding the glenohumeral jointare often diagnosed even in patients without a history oftrauma.3 Management of these patients includes the useof analgesics and nonsteroidal anti-inflammatory drugs(NSAIDs), steroid injections, thermal modalities, ultra-sound (US), and exercise programs. Systematic reviewsof clinical trials on shoulder disorders show little benefitfrom NSAIDs and steroid injections.4,5

Ultrasound is used as a therapeutic modality for manyconditions in many countries6 and for soft tissue disor-ders. When US enters the body, it can exert effects onthe cells and tissues via thermal and nonthermal mech-

anisms, of which some are still inconclusive.6,7 Ultra-sound is believed to differ from superficial heatingmodalities by heating deeper tissues when applied withappropriate intensity and frequency.6 Nonthermaleffects are claimed to promote healing, although this hasnot been proven with in vivo studies.7 Systematic reviewsof clinical trials on shoulder disorders have shown US tobe ineffective in achieving success in the interven-tion.8 –11 The effect of US in the management of softtissue disorders of the shoulder was found to be of littleor no clinical benefit in some studies.12,13 Some stud-ies,14 –16 however, have shown US to be effective inimproving the symptoms. In our experience and con-trary to the published data, US seems to be of some valuein the management of shoulder problems. These con-flicting results led us to plan this placebo-controlledstudy. The aim of our study was to evaluate whether US,

Y Kurtaiş Gürsel, MD, is Assistant Professor, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, University of Ankara,Ankara, Turkey. Address all correspondence to Dr Kurtaiş Gürsel at Sedat Simavi Sok, MESA 6.Blok 37/32 Çankaya, Ankara, Turkey([email protected]).

Y Ulus, MD, is Specialist in Physical Medicine and Rehabilitation, Department of Physical Medicine and Rehabilitation, Bayındır Hospital, Ankara,Turkey.

A Bilgiç, MD, is Assistant Professor, University of Ankara, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, University ofAnkara.

G Dinçer, MD, is Professor, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, University of Ankara.

GJMG van der Heijden, PhD, is Clinical Epidemiologist and Physiotherapist, Julius Center for Health Sciences and Primary Care, UniversityMedical Center, Utrecht, the Netherlands.

Dr Kurtaiş Gürsel and Dr Dinçer provided concept/idea/research design. Dr Kurtaiş Gürsel and Dr van der Heijden provided writing. Dr KurtaişGürsel, Dr Ulus, and Dr Bilgiç provided data collection, and Dr Kurtaiş Gürsel provided data analysis. Dr Kurtaiş Gürsel, Dr Ulus, Dr Bilgiç, andDr Dinçer provided subjects. Dr Kurtaiş Gürsel and Dr Dinçer provided project management. Dr Kurtaiş Gürsel and Dr Ulus providedfacilities/equipment. Dr Dinçer provided institutional liaisons. Dr Ulus was responsible for patient assessment and provided clerical support. Drvan der Heijden provided consultation (including review of manuscript before submission).

The study protocol was approved by the ethics committee of the İbn-i Sina Hospital, University of Ankara.

This article was received December 30, 2002, and was accepted October 20, 2003.

Physical Therapy . Volume 84 . Number 4 . April 2004 Kurtaiş Gürsel et al . 337

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when combined with hot packs and interferential cur-rent, enhances the outcomes of intervention.

Method

SubjectsPatients with soft tissue disorders of shoulder wereconsidered for the study from the outpatient clinic andexamined by the researchers, who are all senior physicalmedicine physicians. Physical, laboratory, and radiolog-ical examinations were used to confirm the diagnosisand rule out other conditions. The following selectioncriteria were used in our study:

1. Shoulder pain and limitation of movement for at least4 weeks prior to the study (to eliminate acute painthat may recover quickly and spontaneously after afew physical therapy sessions).

2. Diagnosis of a soft tissue disorder of the shoulder (eg,bicipital tendinosis, rotator cuff tendinosis [includingrotator cuff tears], subacromial bursitis) by ultra-sonography or magnetic resonance imaging (throughwhich calcific tendinitis was excluded).

3. Absence of direct trauma to the shoulder or thememory of trauma (to exclude probable fractures orresorbing hematoma).

4. Absence of underlying neurologic, inflammatoryrheumatic disease, notably rheumatoid arthritis, sys-temic lupus erythematosus, or extrinsic diseases suchas cervical spondylosis with referring pain to theshoulder. These other diseases were ruled out byphysical examination and further laboratory exami-nations whenever needed.

5. No physical therapy for the shoulder was given in the4 to 5 weeks prior to the study.

Forty patients who fulfilled the selection criteria andsigned informed consent statements were enrolled inthe study and were randomly assigned by the use ofrandom numbers to either a group that received true USor a group that received sham US. The selector (GD),who did not perform any assessment, was aware of therandomization scheme and opened the codes at thestatistical evaluation stage. The assessor (YU) and thesubjects, however, were not informed about the truenature of US application. The treating physical therapistwas aware of the nature of this intervention and thephysical findings of the subjects, but did not change theintervention according to the symptoms during thestudy. Two subjects (one from each group) withdrew forpersonal reasons at the beginning of the study. The

demographic characteristics of the remaining 38 sub-jects are shown in Table 1.

ProcedureThe true-US group received continuous US using aPetsan 250 device* that, according to the manufacturer,operated at a frequency of 1 MHz and at an intensity of1.5 W/cm2. The transducer head had an area of 6.2 cm2 ,an effective radiating area of 5 cm2 , and a beam non-uniformity ratio of 1:6. While sitting on a table, eachsubject placed an arm with the hand supinated in his orher lap. Using slow circular movements, the treatingphysical therapist applied the transducer head over thesuperior and anterior periarticular regions of the sub-ject’s glenohumeral joint, covering an area of approxi-mately 15 cm2. The treatment duration was 10 minutes.For the sham-US intervention, the device was set to the“off” mode. The transducer head was applied to thesame area using the same machine, and Aquasonictransmission gel† was used.

All patients had pain and limitation of motion; there-fore, we did not believe we could treat the sham-USgroup without additional interventions. Other physicaltherapy interventions were applied to subjects in bothgroups. Superficial heat was administered by use of hotpacks (60°C) for 10 minutes. Interferential current wasdelivered using Medi-Link Model 71,‡ which operatedwith a carrier frequency of 4,000 Hz, with an amplitude-modulated frequency of 100 Hz. Rubber bipolar plateelectrodes (6�8 cm) were placed again over the supe-

* Petaş, Ankara, Turkey.† Parker Laboratories Inc, 286 Eldridge Rd, Fairfield, NJ 07004.‡ EMS, Oxfordshire, United Kingdom.

Table 1.Demographic Characteristics of Subjects

True-UltrasoundGroup(n�19)

Sham-UltrasoundGroup(n�19)

Age (y)X 54.16 54.00SD 8.22 9.80Range 38–69 35–69

Time since onset of pain (mo)X 8.68 8.11SD 8.84 10.81Range 1–36 1–42

Sex (female/male) 12/7 14/5

Diagnosis (n)Supraspinatus tendinosis 6 6Supraspinatus partial rupture 11 7Rotator cuff rupture 1 3Biceps tendinosis 8 7

338 . Kurtaiş Gürsel et al Physical Therapy . Volume 84 . Number 4 . April 2004 by guest on August 13, 2013http://ptjournal.apta.org/Downloaded from

rior and anterior periarticular regions of the glenohu-meral joint. The intensity was set according to thesensory threshold level of each patient, and the treat-ment duration was 15 minutes.

Exercise for the shoulder girdle included the active andpassive range of motion (ROM) exercises, stretching,Codmann exercises, and isometric and isotonic exer-cises. The exercises were applied to all of the subjects bythe same physical therapist. The duration of exercise wasa minimum of 15 minutes and a maximum of 30minutes. At the start of the therapy, or when a subjecthad severe pain, passive restricted ROM exercises andgentle stretching were used. At a later phase or whenpain lessened, exercise shifted toward active ROM exer-cises, and gradually isometric and dynamic resistanceexercises were added, resulting in a longer duration ofintervention.

The duration of physical therapy intervention was 15days (5 days each week), which is the usual treatmentregimen in our department’s practice. The treatmentprotocol was not changed during the study in order tostandardize intervention for all subjects. After the studyperiod ended, the subjects’ physical therapy interven-tions were changed, if needed. The subjects were notallowed to take medications other than a simple analge-sic (paracetamol, maximum of 500 –1,000 mg daily dueto their pain).

Outcome MeasuresPain intensity at rest and with motion was measuredusing a 4-point Likert scale (0�no pain, 1�mild pain,2�moderate pain, 3�severe pain). Passive and activeROM in flexion, extension, abduction, adduction, andmedial (internal) and lateral (external) rotation wasmeasured using a goniometer. All of the measurementswere done while the subjects were positioned supineexcept for ROM in extension, which was measured whilethe subjects were sitting erect in a chair. Before the studybegan, the assessor (YU) performed repetitive goniomet-ric measurements of the shoulder joints of 10 subjectswith no known pathology or impairments to enhancethe reliability of her assessment, but no other reliabilitystudy was performed. The Health Assessment Question-naire (HAQ)17 was used to assess activities of daily living,and only items regarding upper-extremity function wereincluded. The HAQ was shown to be sensitive fordetecting changes in patients with rheumatoid arthritisand patients who had undergone joint replacementsurgery, but no further studies have been done toevaluate the sensitivity of the tool in patients withshoulder disorders.18,19 Shoulder disability was assessedwith the Shoulder Disability Questionnaire (SDQ),which was shown to be responsive to changes in symp-toms and physical findings.20,21 When the study began

and on the day following the last day (15th day) ofintervention, the same physician (YU), who was maskedto the randomization, took all of the measurements.

Data AnalysisDifferences between baseline and postintervention mea-surements for each studied outcome were analyzedwithin and between the groups. Repeated measurementsobtained before and after intervention were analyzedwithin groups by a Wilcoxon rank sum test. Postinterven-tion changes in categorical data within groups were ana-lyzed by chi-square test with Yates correction. Between-group comparisons of differences after intervention wereperformed by a Mann-Whitney U test at a .05 level ofsignificance.

ResultsSeventeen subjects (89%) in the true-US group and 16subjects (84%) in the sham-US group completed the15-day intervention program. One subject from thetrue-US group and 1 subject from the sham-US groupwithdrew from the study because they could not sparetime for the physical therapy sessions. Another subjectfrom the true-US group and 2 other subjects from thesham-US group withdrew without any explanation.

Baseline and postintervention measurements are dis-played in Table 2. No differences between groups wereobserved in the baseline measurements, and variabilitywas relatively limited for almost all measurements; thatis, standard deviations of the observed means of thechanges over time were relatively small. For the true-USgroup, there were preintervention-postintervention dif-ferences for pain, ROM (except for passive abduction),and HAQ and SDQ scores. For the sham-US group,improvement was detected for pain, ROM (except forpassive lateral rotation), and HAQ and SDQ scores. Thepreintervention-postintervention differences in the mea-surements, however, did not show any statistical differ-ence between groups (Tab. 3).

DiscussionIn the management of soft tissue disorders, US has beenused for more than 30 years.22,23 Increased blood flow,vascular permeability, and cell metabolism; enhance-ment of fibrous tissue extensibility; and muscle relax-ation are the purported physiologic effects of US. Ultra-sound is proposed to promote healing and regenerationin inflamed tissue, to reduce pain, and to improveROM,24,25 and this is the rationale for the use of US forthe management of soft tissue disorders in all joints,including the shoulder. In our experience, US is com-monly prescribed in addition to other interventions suchas electrical stimulation and exercise. We used interfer-ential current in our study because it is believed by someauthors26 –28 to have analgesic effects, but these effects

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Table

Ass

essm

entP

aram

eter

sof

True

-Ultr

asou

ndan

dSh

am-U

ltras

ound

Gro

ups

Befo

rean

fter

Inte

rven

tion

Vari

able

True-U

ltra

sound

Gro

(n�

)

Sham

-Ultra

sound

Gro

(n�

16)

Befo

reIn

terv

ention

Aft

Inte

rvention

Befo

reIn

terv

ention

Aft

Inte

rvention

XSD

Range

XSD

Range

XSD

Range

XSD

Range

Pain

ratin

g(o

–3Li

kert

scal

e)A

tres

t2.4

0.5

1–2

1.0

0.1

1–1

.00

1.8

0.7

1–3

1.3

0.4

1–2

.007

With

mot

ion

2.4

0.5

2–3

1.9

0.2

1–2

.00

2.7

0.4

2–3

2.1

0.2

2–3

.001

Flex

ion

ARO

M(°

)127.6

4.9

–16

.41

2.6

0–1

.00

3.7

.390–1

160.3

12.0

140–1

.0001

PRO

M(°

)145.3

24.0

0–1

8.2

.71

–18

0.0

.11

8.9

110–1

172.8

10.3

150–1

.0001

Abd

uctio

ROM

(°)

105.5

29.4

60–1

0.2

.01

00–1

.00

.43

7.0

60–1

162.2

16.7

120–1

.001

PRO

M(°

)127.3

25.4

80–1

0.6

.71

20–1

.00

.52

5.9

100–1

174.4

10.7

140–1

.001

Late

ralr

otat

ion

ARO

M(°

)65.8

4.0

20–7

1.4

.53

0–7

0.0

4.1

.720–7

087.8

5.4

60–7

0.0

PRO

M(°

)77.3

17.9

40–7

4.7

.14

0–7

0.0

.51

6.9

40–7

089.3

2.5

70–7

0.0

Med

ialr

otat

ion

ARO

M(°

)48.2

4.0

20–6

1.4

.74

0–6

0.0

2.8

.820–7

072.2

13.4

50–7

0.0

PRO

M(°

)68.2

20.5

30–6

0.6

.35

0–6

0.0

.11

7.2

40–7

088.1

7.5

60–7

0.0

Exte

nsio

ROM

(°)

43.5

9.9

30–6

1.7

9.0

–60

.00

.61

1.5

30–6

557.2

7.9

45–6

5.0

ARO

M(°

)55.0

7.0

40–6

7.9

8.1

–70

.12

.86

.345–6

560.3

6.1

50–7

0.0

0.5

0.2

–2.5

0.3

0.2

0–0

.8.0

1.2

0.5

0.6

–2.5

0.4

0.2

0.1

–0.8

.0001

SDQ

76.1

11.7

46–1

.52

0.3

6–8

0.0

.01

1.8

40–1

38.2

15.6

4–7

3.0

001

M�

acti

vera

nge

tio

�p

assi

vera

nge

tio

Q�

Hea

lth

Ass

essm

ent

esti

nai

re,

SDQ

�Sh

lder

Dis

abil

ity

esti

nai

re.

bSt

atis

tica

lly

sign

ific

ant

dif

fere

nce

(sta

tist

ical

leve

fsi

gnif

ican

ce:

.05,

Wil

coxo

nsi

gned

ran

kste

st).

340 . Kurtaiş Gürsel et al Physical Therapy . Volume 84 . Number 4 . April 2004 by guest on August 13, 2013http://ptjournal.apta.org/Downloaded from

are yet to be determined because of the inconclusiveresults obtained by other researchers.29,30

In our study, US was applied in addition to the use ofsuperficial heat because of the often-used hypothesisthat US further affects healing in people with soft tissuediseases. Our study did not allow us to determinewhether the heating effect of US was masked by theapplication of superficial heat. The results of our maskedstudy demonstrated that at the end of the interventionperiod, our subjects with soft tissue disorders of theshoulder showed improvements in pain, ROM, andHAQ and SDQ scores when either true US or sham USwas administered in addition to superficial heat, inter-ferential current, and exercise, but neither group wascompared with a group that received no intervention.Our groups were similar after randomization, with fewdropouts, and there were no differences between thegroups at our short-term follow-up. Whether the changeswe observed would remain over time cannot bedetermined.

In a systematic review of randomized clinical trials forpatients who received physical therapy for soft tissuedisorders of the shoulder, 6 trials on the effects of USwere found to be of acceptable methodological quality.8

However, US did not seem to be effective in placebo-controlled trials and was no better than cold therapy,steroid injections, NSAIDs, acupuncture, or transcutane-ous electrical stimulation. In another systematic review,van der Windt et al9 showed a lack of sufficient data tosupport positive results about the effectiveness of US formusculoskeletal disorders, including soft tissue prob-lems of the shoulder.

Several authors12,13,31 have reported that there were nodifferences between subjects with soft tissue disorders ofthe shoulder who received true US and those whoreceived sham US. Studies by other researchers14 –16support the efficacy of US therapy in improving pain,activities of daily living, and quality of life. The subjectsin these studies varied from another. For instance,Ebenbichler et al,15 who reported no effects of US onpain and disability in the long term, found changes inthe calcific deposits of their subjects with calcific tendi-nitis of the shoulder. We excluded patients with calcifictendinitis of the shoulder in our study; therefore, ourstudy is not comparable to that of Ebenbichler et al.

Despite various suggestions provided in classical text-books on physical treatments,24,25 there is no acceptedstandardized method for US application. Yet, although

Table 3.Change Over Time in Measurements From the True-Ultrasound and Sham-Ultrasound Groups

Variablea

True-Ultrasound Group (n�17) Sham-Ultrasound Group (n�16)

Preintervention-PostinterventionDifference

X SD Range X SD Range

Pain rating (on 0–3 Likert scale)At rest 0.7 0.4 0–1 0.5 0.6 0–2 .36With motion 0.4 0.5 0–1 0.6 0.4 0–1 .21

FlexionAROM (°) 29.4 23.6 0–70 36.5 25.5 5–90 .39PROM (°) 22.9 20.1 0–60 23.7 16.4 5–60 .87

AbductionAROM (°) 44.1 24.6 10–90 48.7 29.9 0–100 .65PROM (°) 33.2 22.7 5–80 32.8 26.3 0–80 .85

Lateral rotationAROM (°) 15.5 16.9 0–50 13.7 18.3 0–50 .69AROM (°) 7.4 12.0 0–40 6.8 15.3 0–50 .45

Medial rotationAROM (°) 24.4 17.1 0–70 28.7 17.3 0–55 .28PROM (°) 14.7 16.1 0–60 14.1 16.0 0–50 .79

ExtensionAROM (°) 10.0 8.4 0–25 11.5 8.1 0–25 .55PROM (°) 4.1 6.6 0–25 3.4 6.2 0–25 .82

HAQ 0.6 0.5 0.1–2.3 0.8 0.5 0.2–2.3 .27

SDQ 34.5 19.0 1–12 36.7 18.1 1–12 .71

a AROM�active range of motion, PROM�passive range of motion. HAQ�Health Assessment Questionnaire, SDQ�Should Disability Questionnaire.b Statistical level of significance: .05, Mann-Whitney U test.

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there is no evidence from well-designed studies that onemethod of application outperforms another, we cannotbe sure which method is the best. Treatment intensity,duration, and frequency and localization of US applica-tion were not the same in all the trials cited. In 2studies,13,14 the frequency of US was the same as in ourstudy (1 MHz). Commonly, US is applied as aco-intervention. The co-interventions in the cited studiesalso were very different. Ginn et al32 reported thatsubjects who received a program of exercise aimed atrestoring force, length, and control of muscles demon-strated better outcomes than did subjects who receivedno intervention. A comparison of groups that receivedeither true or sham US with a group that did not receiveUS, however, did not show results favoring the use of US,either on short- or long-term follow-up.12 A recentoverview of research on shoulder disorders has shownthat evidence for an effect of physical therapy on thelong-term outcome of shoulder disorders is lacking.33

The results of our study showed that there were nodifferences between the outcomes of 2 groups. Ourstudy provided no evidence that true US, as comparedwith sham US, is beneficial when applied in addition tosome commonly used interventions, including modali-ties such as exercise therapy. This result seems to be inconcordance with the findings of many other studies.Due to our small sample size, however, our results lackstatistical power. In addition, the between-group differ-ences were too small to be clinically relevant. Given thelack of between-group differences at short-term followup, it is unlikely that with evaluation of effects at a longerterm an effect in favor of true US would be observed.

ConclusionBased on the literature and the results of our study, weconclude that there is insufficient evidence to merit wideuse of 1-MHz US in combination with other interven-tions in the management of painful shoulder conditions.In our opinion, with the guidance of randomized con-trolled trials, it is time to use interventions that favorminimal use of time and maximum economy. Althoughfurther studies are needed on the effectiveness of physicaltherapy interventions in the management of painful con-ditions such as shoulder disorders, it is apparent thatadding US to a well-planned intervention regimen has nobenefit. We believe future research should consider com-parisons of interventions with painkillers, NSAIDs, steroidinjections, or even the use of a wait-and-see policy.

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