2004; 84:336-343.PHYS THER. Dinçer and Geert JMG van der Heijden Yesim Kurtais Gürsel, Yasemin Ulus, Ayse Bilgiç, Gülay Placebo-Controlled Trial Disorders of the Shoulder: A Randomized Adding Ultrasound in the Management of Soft Tissue

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Adding Ultrasound in the Management of Soft Tissue Disorders of the Shoulder: A Randomized Placebo-Controlled Trial

Background and Purpose. There is still a lack of evidence about the beneficial effects of ultrasound (US) intervention for the management of soft tissue problems. Thus, this study was designed to assess the effectiveness of US over a placebo intervention when added to other physical therapy interventions and exercise in the management of shoulder disorders. Subjects and Methods. Forty patients who were diagnosed by ultrasonography or magnetic resonance imaging to have a periarticular soft tissue disorder of the shoulder were randomly assigned to either a group that received true US (n�20; mean time since onset of pain�8.7 months, SD�8.8, range�1–36) or a group that received 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), and an exercise program (15–30 minutes) were administered to both groups 5 days each week for 3 weeks. Results. Subjects showed within-group improvements in pain, range of motion, Shoulder Dis- ability Questionnaire scores, and Health Assessment Questionnaire scores 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, brings no further benefit when applied in addition to other physical therapy interventions in the management of soft tissue disorders of the shoulder. [Kurtaiş Gürsel Y, Ulus Y, Bilgiç A, et al. Adding ultrasound in 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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S houlder pain is a major reason that patients seek consultations with physicians. Pain restricts shoulder motion and limits daily activities, caus- ing disability.1,2 In general, soft tissue impair-

ments and pathologies such as inflammation of the tendons and bursae surrounding the glenohumeral joint are often diagnosed even in patients without a history of trauma.3 Management of these patients includes the use of analgesics and nonsteroidal anti-inflammatory drugs (NSAIDs), steroid injections, thermal modalities, ultra- sound (US), and exercise programs. Systematic reviews of clinical trials on shoulder disorders show little benefit from NSAIDs and steroid injections.4,5

Ultrasound is used as a therapeutic modality for many conditions in many countries6 and for soft tissue disor- ders. When US enters the body, it can exert effects on the 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 heating modalities by heating deeper tissues when applied with appropriate intensity and frequency.6 Nonthermal effects are claimed to promote healing, although this has not been proven with in vivo studies.7 Systematic reviews of clinical trials on shoulder disorders have shown US to be ineffective in achieving success in the interven- tion.8 –11 The effect of US in the management of soft tissue disorders of the shoulder was found to be of little or no clinical benefit in some studies.12,13 Some stud- ies,14 –16 however, have shown US to be effective in improving the symptoms. In our experience and con- trary to the published data, US seems to be of some value in the management of shoulder problems. These con- flicting results led us to plan this placebo-controlled study. 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 of Ankara.

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, University Medical 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 Kurtaiş Gürsel, Dr Ulus, and Dr Bilgiç provided data collection, and Dr Kurtaiş Gürsel provided data analysis. Dr Kurtaiş Gürsel, Dr Ulus, Dr Bilgiç, and Dr Dinçer provided subjects. Dr Kurtaiş Gürsel and Dr Dinçer provided project management. Dr Kurtaiş Gürsel and Dr Ulus provided facilities/equipment. Dr Dinçer provided institutional liaisons. Dr Ulus was responsible for patient assessment and provided clerical support. Dr van 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

Subjects Patients with soft tissue disorders of shoulder were considered for the study from the outpatient clinic and examined by the researchers, who are all senior physical medicine physicians. Physical, laboratory, and radiolog- ical examinations were used to confirm the diagnosis and rule out other conditions. The following selection criteria were used in our study:

1. Shoulder pain and limitation of movement for at least 4 weeks prior to the study (to eliminate acute pain that may recover quickly and spontaneously after a few physical therapy sessions).

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

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

4. Absence of underlying neurologic, inflammatory rheumatic disease, notably rheumatoid arthritis, sys- temic lupus erythematosus, or extrinsic diseases such as cervical spondylosis with referring pain to the shoulder. These other diseases were ruled out by physical examination and further laboratory exami- nations whenever needed.

5. No physical therapy for the shoulder was given in the 4 to 5 weeks prior to the study.

Forty patients who fulfilled the selection criteria and signed informed consent statements were enrolled in the study and were randomly assigned by the use of random numbers to either a group that received true US or a group that received sham US. The selector (GD), who did not perform any assessment, was aware of the randomization scheme and opened the codes at the statistical evaluation stage. The assessor (YU) and the subjects, however, were not informed about the true nature of US application. The treating physical therapist was aware of the nature of this intervention and the physical findings of the subjects, but did not change the intervention according to the symptoms during the study. Two subjects (one from each group) withdrew for personal reasons at the beginning of the study. The

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

Procedure The true-US group received continuous US using a Petsan 250 device* that, according to the manufacturer, operated at a frequency of 1 MHz and at an intensity of 1.5 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, each subject placed an arm with the hand supinated in his or her lap. Using slow circular movements, the treating physical therapist applied the transducer head over the superior 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 the same area using the same machine, and Aquasonic transmission gel† was used.

All patients had pain and limitation of motion; there- fore, we did not believe we could treat the sham-US group without additional interventions. Other physical therapy interventions were applied to subjects in both groups. Superficial heat was administered by use of hot packs (60°C) for 10 minutes. Interferential current was delivered using Medi-Link Model 71,‡ which operated with a carrier frequency of 4,000 Hz, with an amplitude- modulated frequency of 100 Hz. Rubber bipolar plate electrodes (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- Ultrasound Group (n�19)

Sham- Ultrasound Group (n�19)

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

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

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

Diagnosis (n) Supraspinatus tendinosis 6 6 Supraspinatus partial rupture 11 7 Rotator cuff rupture 1 3 Biceps 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 the sensory threshold level of each patient, and the treat- ment duration was 15 minutes.

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

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

Outcome Measures Pain intensity at rest and with motion was measured using a 4-point Likert scale (0�no pain, 1�mild pain, 2�moderate pain, 3�severe pain). Passive and active ROM in flexion, extension, abduction, adduction, and medial (internal) and lateral (external) rotation was measured using a goniometer. All of the measurements were done while the subjects were positioned supine except for ROM in extension, which was measured while the subjects were sitting erect in a chair. Before the study began, the assessor (YU) performed repetitive goniomet- ric measurements of the shoulder joints of 10 subjects with no known pathology or impairments to enhance the reliability of her assessment, but no other reliability study was performed. The Health Assessment Question- naire (HAQ)17 was used to assess activities of daily living, and only items regarding upper-extremity function were included. The HAQ was shown to be sensitive for detecting changes in patients with rheumatoid arthritis and patients who had undergone joint replacement surgery, but no further studies have been done to evaluate the sensitivity of the tool in patients with shoulder disorders.18,19 Shoulder disability was assessed with 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) of intervention, the same physician (YU), who was masked to the randomization, took all of the measurements.

Data Analysis Differences between baseline and postintervention mea- surements for each studied outcome were analyzed within and between the groups. Repeated measurements obtained before and after intervention were analyzed within 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 were performed by a Mann-Whitney U test at a .05 level of significance.

Results Seventeen subjects (89%) in the true-US group and 16 subjects (84%) in the sham-US group completed the 15-day intervention program. One subject from the true-US group and 1 subject from the sham-US group withdrew from the study because they could not spare time for the physical therapy sessions. Another subject from the true-US group and 2 other subjects from the sham-US group withdrew without any explanation.

Baseline and postintervention measurements are dis- played in Table 2. No differences between groups were observed in the baseline measurements, and variability was relatively limited for almost all measurements; that is, standard deviations of the observed means of the changes over time were relatively small. For the true-US group, 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 for passive lateral rotation), and HAQ and SDQ scores. The preintervention-postintervention differences in the mea- surements, however, did not show any statistical differ- ence between groups (Tab. 3).

Discussion In the management of soft tissue disorders, US has been used 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 regeneration in inflamed tissue, to reduce pain, and to improve ROM,24,25 and this is the rationale for the use of US for the management of soft tissue disorders in all joints, including the shoulder. In our experience, US is com- monly prescribed in addition to other interventions such as electrical stimulation and exercise. We used interfer- ential current in our study because it is believed by some authors26 –28 to have analgesic effects, but these effects

Physical Therapy . Volume 84 . Number 4 . April 2004 Kurtaiş Gürsel et al . 339

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

In our study, US was applied in addition to the use of superficial heat because of the often-used hypothesis that US further affects healing in people with soft tissue diseases. Our study did not allow us to determine whether the heating effect of US was masked by the application of superficial heat. The results of our masked study demonstrated that at the end of the intervention period, our subjects with soft tissue disorders of the shoulder showed improvements in pain, ROM, and HAQ and SDQ scores when either true US or sham US was administered in addition to superficial heat, inter- ferential current, and exercise, but neither group was compared with a group that received no intervention. Our groups were similar after randomization, with few dropouts, and there were no differences between the groups at our short-term follow-up. Whether the changes we observed would remain over time cannot be determined.

In a systematic review of randomized clinical trials for patients who received physical therapy for soft tissue disorders of the shoulder, 6 trials on the effects of US were 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 to support positive results about the effectiveness of US for musculoskeletal disorders, including soft tissue prob- lems of the shoulder.

Several authors12,13,31 have reported that there were no differences between subjects with soft tissue disorders of the shoulder who received true US and those who received sham US. Studies by other researchers14 –16 support the efficacy of US therapy in improving pain, activities of daily living, and quality of life. The subjects in these studies varied from another. For instance, Ebenbichler et al,15 who reported no effects of US on pain and disability in the long term, found changes in the calcific deposits of their subjects with calcific tendi- nitis of the shoulder. We excluded patients with