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Adding ultrasound in the management of soft tissue disorders of the shoulder: a randomized placebo-controlled trial.


Shoulder pain is a major reason that patients seek consultations with physicians. Pain restricts shoulder motion and limits daily activities, causing disability. (1,2) In general, soft tissue impairments and pathologies such as inflammation of the tendons and bursae Bursae
A closed sac lined with a synovial membrane and filled with fluid, usually found in areas subject to friction, such as where a tendon passes over a bone.
 surrounding the glenohumeral joint The glenohumeral joint, commonly known as the shoulder joint, is a synovial ball and socket joint and involves articulation between the glenoid fossa of the scapula (shoulder blade) and the head of the humerus (upper arm bone).  are often diagnosed even in patients without a history of trauma. (3) Management of these patients includes the use of analgesics Analgesics Definition

Analgesics are medicines that relieve pain.
Purpose

Analgesics are those drugs that mainly provide pain relief.
 and nonsteroidal anti-inflammatory drugs Nonsteroidal Anti-Inflammatory Drugs Definition

Nonsteroidal anti-inflammatory drugs are medicines that relieve pain, swelling, stiffness, and inflammation.
 (NSAIDs), steroid injections, thermal modalities, ultrasound (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 therapeutic modality,
n an intervention used to heal someone. See model, biomedical and homeopathy.
 for many conditions in many countries (6) and for soft tissue disorders. When US enters the body, it can exert effects on the cells and tissues via thermal and nonthermal mechanisms, of which some are still inconclusive. (6,7) Ultrasound 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 in vivo /in vi·vo/ (ve´vo) [L.] within the living body.

in vi·vo
adj.
Within a living organism.



in vivo adv.
 studies. (7) Systematic reviews of clinical trials on shoulder disorders have shown US to be ineffective in achieving success in the intervention. (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 studies, (14-16) however, have shown US to be effective in improving the symptoms. In our experience and contrary to the published data, US seems to be of some value in the management of shoulder problems. These conflicting results led us to plan this placebo-controlled study. The aim of our study was to evaluate whether US, when combined with hot packs and interferential current, 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 radiological 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 bicipital /bi·cip·i·tal/ (bi-sip´i-t'l) having two heads; pertaining to a biceps muscle.

bicipital

having two heads; pertaining to a biceps muscle.
 tendinosis, rotator cuff rotator cuff
n.
A set of muscles and tendons that secures the arm to the shoulder joint and permits rotation of the arm. Also called musculotendinous cuff.
 tendinosis [including rotator cuff tears], subacromial bursitis Subacromial bursitis is inflammation of the subacromial bursa, which lies between the acromion and the head of the humerus leading to extreme pain.

The cause of the condition is often unclear.
) by ultrasonography ultrasonography /ul·tra·so·nog·ra·phy/ (-so-nog´rah-fe) the imaging of deep structures of the body by recording the echoes of pulses of ultrasonic waves directed into the tissues and reflected by tissue planes where there is a change in  of magnetic resonance imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures.  (through which calcific tendinitis Calcific Tendinitis (also calcific/calcifying/calcified/calcareous tenonitis/tendonitis/tendinopathy, and tendinosis calcarea  was excluded).

3. Absence of direct trauma to the shoulder or the memory of trauma (To exclude probable fractures or resorbing hematoma hematoma /he·ma·to·ma/ (he?mah-to´mah) a localized collection of extravasated blood, usually clotted, in an organ, space, or tissue. ).

4. Absence of underlying neurologic, inflammatory rheumatic disease Rheumatic disease
A type of disease involving inflammation of muscles, joints, and other tissues.

Mentioned in: Temporal Arteritis
, notably rheumatoid arthritis rheumatoid arthritis

Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course.
, systemic lupus erythematosus Systemic Lupus Erythematosus Definition

Systemic lupus erythematosus (also called lupus or SLE) is a disease where a person's immune system attacks and injures the body's own organs and tissues. Almost every system of the body can be affected by SLE.
, or extrinsic EVIDENCE, EXTRINSIC. External evidence, or that which is not contained in the body of an agreement, contract, and the like.
     2. It is a general rule that extrinsic evidence cannot be admitted to contradict, explain, vary or change the terms of a contract or of a
 diseases such as cervical spondylosis cervical spondylosis

Degenerative disease of the neck vertebrae. Compression of the spinal cord and cervical nerves by narrowing of spaces between vertebrae causes radiating neck or arm pain and stiffness, restricted head movement, headaches, spastic paralysis, and arm and
 with referring pain to the shoulder. These other diseases were ruled out by physical examination and further laboratory examinations 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 randomization (ranˈ·d·m  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 according to
prep.
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

3.
 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 subjects ate 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 (MegaHertZ) One million cycles per second. It is used to measure the transmission speed of electronic devices, including channels, buses and the computer's internal clock. A one-megahertz clock (1 MHz) means some number of bits (16, 32, 64, etc.  and at an intensity of 1.5 W/[cm.sup.2]. The transducer transducer, device that accepts an input of energy in one form and produces an output of energy in some other form, with a known, fixed relationship between the input and output.  head had an area of 6.2 [cm.sup.2], an effective radiating area of 5 [cm.sup.2], and a beam nonuniformity 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 periarticular /peri·ar·tic·u·lar/ (-ahr-tik´u-lar) around a joint.

per·i·ar·tic·u·lar
adj.
Surrounding a joint.



periarticular

situated around a joint.
 regions of the subject's glenohumeral joint, covering an area of approximately 15 [cm.sup.2]. 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 ([dagger]) was used.

All patients had pain and limitation of motion; therefore, 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[degrees]C) for 10 minutes. Interferential current was delivered using Medi-Link Model 71, ([double dagger double dagger
n.
A reference mark () used in printing and writing. Also called diesis.

Noun 1.
]) which operated with a carrier frequency of 4,000 Hz, with an amplitude-modulated frequency of 100 Hz. Rubber bipolar plate electrodes (6x8 cm) were placed again over the superior and anterior periarticular regions of the glenohumeral joint. The intensity was set according to the sensory threshold Sensory threshold is a theoretical concept used in psychophysics. A stimulus that is less intense than the sensory threshold will not elicit any sensation. Methods have been developed to measure thresholds in any of the senses.  level of each patient, and the treatment duration was 15 minutes.

Exercise for the shoulder girdle shoulder girdle
n.
The pectoral girdle, especially of a human.
 included the active and passive range of motion (ROM) exercises, stretching, Codmann exercises, and isometric isometric /iso·met·ric/ (-met´rik) maintaining, or pertaining to, the same measure of length; of equal dimensions.

i·so·met·ric
adj.
1.
 and isotonic exercises. 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 of when pain lessened, exercise shifted toward active ROM exercises, 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 interventions were changed, if needed. The subjects were not allowed to take medications other than a simple analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs  (paracetamol paracetamol

see acetaminophen.


acetaminophen, paracetamol

an analgesic and antipyretic drug in dogs. It is contraindicated for cats because of serious side-effects which include intravascular hemolysis, methemoglobinemia and hepatic necrosis.
, 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 Likert scale A subjective scoring system that allows a person being surveyed to quantify likes and preferences on a 5-point scale, with 1 being the least important, relevant, interesting, most ho-hum, or other, and 5 being most excellent, yeehah important, etc  (0=no pain, 1 =mild pain, 2=moderate pain, 3=severe pain). Passive and active ROM in flexion flexion /flex·ion/ (flek´shun) the act of bending or the condition of being bent.

flex·ion
n.
1. The act of bending a joint or limb in the body by the action of flexors.

2.
, extension, abduction Abduction
Balfour, David

expecting inheritance, kidnapped by uncle. [Br. Lit.: Kidnapped]

Bertram, Henry

kidnapped at age five; taken from Scotland. [Br. Lit.
, adduction adduction /ad·duc·tion/ (ah-duk´shun) the act of adducting; the state of being adducted.
adduction (
, and medial (internal) and lateral (external) rotation were measured using a goniometer goniometer /go·ni·om·e·ter/ (go?ne-om´e-ter)
1. an instrument for measuring angles.

2. a plank that can be tilted at one end to any height, used in testing for labyrinthine disease.
. 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 goniometric go·ni·om·e·ter  
n.
1. An optical instrument for measuring crystal angles, as between crystal faces.

2. A radio receiver and directional antenna used as a system to determine the angular direction of incoming radio signals.
 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 Questionnaire (HAQ HAQ Health Assessment Questionnaire
HAQ Harvard Asia Quarterly
) (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 SDQ Santo Domingo, Dominican Republic - Las Americas (Airport Code)
SDQ Strengths and Difficulties Questionnaires
SDQ Sexual Disaster Quartet (band)
SDQ Service Delivery & Quality
), which was shown to be responsive to changes in symptoms 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 measurements 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. Postintervention changes in categorical data categorical data

data relating to category such as qualitative data, e.g. dog, cat, female. It may be nominal when a name is used, e.g. location, breed, or ordinal when a range of categories is used, e.g. calf, yearling, cow.
 within groups were analyzed by chi-square test chi-square test: see statistics.  with Yates correction. Between-group comparisons of differences after intervention were performed by a Mann-Whitney U test Mann-Whitney U test,
n.pr See test, Mann-Whitney U.
 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 displayed 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 differences 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 lateral rotation External rotation, see there ), and HAQ and SDQ scores. The preintervention-postintervention differences in the measurements, however, did not show any statistical difference 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 Vascular permeability characterizes the capacity of a blood vessel wall to pass through small molecules (ions, water, nutrients) or even whole cells (lymphocytes on their way to the site of inflammation). Blood vessel walls are lined by a single layer of endothelial cells. , and cell metabolism Cell metabolism

The sum of chemical reactions which transpire within cells. The cell performs chemical, osmotic, mechanical, and electrical work, for which it needs energy.
; enhancement of fibrous tissue fibrous tissue
n.
Tissue composed of bundles of collagenous white fibers between which are rows of connective tissue cells.
 extensibility; and muscle relaxation are the purported physiologic effects of US. Ultrasound 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 commonly prescribed in addition to other interventions such as electrical stimulation and exercise. We used interferential current in our study because it is believed by some authors (26-28) to have analgesic effects, but these effects 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, interferential 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 randomized clinical trial,
n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies.
 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 transcutaneous transcutaneous /trans·cu·ta·ne·ous/ (-ku-ta´ne-us) transdermal.

trans·cu·ta·ne·ous
adj.
Transdermal.
 electrical stimulation. In another systematic review, van der Windt et al (9) showed a lack of sufficient data to support positive results about the effectiveness of US for musculoskeletal disorders, including soft tissue problems of the shoulder.

Several authors (12,13,31) 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 researchers (14-16) 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 calcific /cal·cif·ic/ (-ik) forming lime.

calcific

forming lime.
 deposits of their subjects with calcific tendinitis of the shoulder. We excluded patients with calcific tendinitis of the shoulder in our study; therefore, our study is not comparable to that of Ebenbichler et al.

Despite various suggestions provided in classical textbooks on physical treatments, (24,25) there is no accepted standardized method for US application. Yet, although there is no evidence from well-designed studies that one method of application outperforms another, we cannot be sure which method is the best. Treatment intensity, duration, and frequency and localization Customizing software and documentation for a particular country. It includes the translation of menus and messages into the native spoken language as well as changes in the user interface to accommodate different alphabets and culture. See internationalization and l10n.  of US application were not the same in all the trials cited. In 2 studies, (13,14) the frequency of US was the same as in our study (1 MHz). Commonly, US is applied as a co-intervention. The co-interventions in the cited studies also were very different. Ginn et al (32) reported that subjects who received a program of exercise aimed at restoring force, length, and control of muscles demonstrated better outcomes than did subjects who received no intervention. A comparison of groups that received either true or sham US with a group that did not receive US, however, did not show results favoring the use of US, either on short- or long-term follow-up. (12) A recent overview of research on shoulder disorders has shown that evidence for an effect of physical therapy on the long-term outcome of shoulder disorders is lacking. (33)

The results of our study showed that there were no differences between the outcomes of 2 groups. Our study provided no evidence that true US, as compared with sham US, is beneficial when applied in addition to some commonly used interventions, including modalities such as exercise therapy. This result seems to be in concordance concordance /con·cor·dance/ (-kord´ins) in genetics, the occurrence of a given trait in both members of a twin pair.concor´dant

con·cor·dance
n.
 with the findings of many other studies. Due to our small sample size, however, our results lack statistical power. In addition, the between-group differences were too small to be clinically relevant. Given the lack of between-group differences at short-term follow up, it is unlikely that with evaluation of effects at a longer term an effect in favor of true US would be observed.

Conclusion

Based on the literature and the results of our study, we conclude that there is insufficient evidence insufficient evidence n. a finding (decision) by a trial judge or an appeals court that the prosecution in a criminal case or a plaintiff in a lawsuit has not proved the case because the attorney did not present enough convincing evidence.  to merit wide use of 1-MHz US in combination with other interventions in the management of painful shoulder conditions. In our opinion, with the guidance of randomized controlled trials, it is time to use interventions that favor minimal use of dine and maximum economy. Although further studies are needed on the effectiveness of physical therapy interventions in the management of painful conditions such as shoulder disorders, it is apparent that adding US to a well-planned intervention regimen has no benefit. We believe future research should consider comparisons of interventions with painkillers, NSAIDs, steroid injections, or even the use of a wait-and-see policy.
Table 1.
Demographic Characteristics of Subjects

                                  True-        Sham-
                                  Ultrasound   Ultrasound
                                  Group        Group
                                  (n=19)       (n=19)

Age (y)
  [bar.X]                           54.16        54.00
  SD                                 8.22         9.80
  Range                             38-69        35-69

Time since onset of pain (mo)
  [bar.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

Table 2.
Assessment Parameters of True-Ultrasound and Sham-Ultrasound Groups
Before and After Intervention

                                       True-Ultrasound
                                        Group (n=17)

                                     Before Intervention

Variable (a)                        [bar.X]   SD      Range

Pain rating (on 0-3 Likert scale)
  At rest                              2.4     0.5     1-2
  With motion                          2.4     0.5     2-3

Flexion
  AROM ([degrees])                   127.6     4.9    80-160
  PROM ([degrees])                   145.3    24.0   100-180

Abduction
  AROM ([degrees])                   105.5    29.4    60-155
  PROM ([degrees])                   127.3    25.4    80-165

Lateral rotation
  AROM ([degrees])                    65.8     4.0    20-70
  PROM ([degrees])                    77.3    17.9    40-70

Medial rotation
  AROM ([degrees])                    48.2     4.0    20-60
  PROM ([degrees])                    68.2    20.5    30-60

Extension
  AROM ([degrees])                    43.5     9.9    30-60
  AROM ([degrees])                    55.0     7.0    40-65

HAQ                                    1       0.5   0.2-2.5

SDQ                                   76.1    11.7    46-100

                                      True-Ultrasound Group (n=17)

                                     After Intervention

                                    [bar
Variable (a)                         .X]    SD      Range    P

Pain rating (on 0-3 Likert scale)
  At rest                             1.0    0.1     1-1     .001 (b)
  With motion                         1.9    0.2     1-2     .005 (b)

Flexion
  AROM ([degrees])                  156.4   12.6   120-170   .001 (b)
  PROM ([degrees])                  168.2   11.7   130-180   .001 (b)

Abduction
  AROM ([degrees])                  150.2   20.0   100-180   .0001 (b)
  PROM ([degrees])                  160.6   16.7   120-180   .0001 (b)

Lateral rotation
  AROM ([degrees])                   81.4   15.5    30-70    .005 (b)
  PROM ([degrees])                   84.7   12.1    40-70    .01 (b)

Medial rotation
  AROM ([degrees])                   71.4   18.7    40-60    .001 (b)
  PROM ([degrees])                   80.6   15.3    50-60    .01 (b)

Extension
  AROM ([degrees])                   51.7    9.0    35-60    .008 (b)
  AROM ([degrees])                   57.9    8.1    40-70    .12

HAQ                                   0.3    0.2     0-0.8   .0001 (b)

SDQ                                  41.5   20.3     6-80    .0001 (b)

                                      Sham-Ultrasound
                                        Group (n=16)

                                     Before Intervention

Variable (a)                        [bar.X]   SD     Range

Pain rating (on 0-3 Likert scale)
  At rest                              1.8     0.7     1-3
  With motion                          2.7     0.4     2-3

Flexion
  AROM ([degrees])                   123.7    24.3    90-160
  PROM ([degrees])                   149.1    18.9   110-175

Abduction
  AROM ([degrees])                   113.4    37.0    60-180
  PROM ([degrees])                   141.5    25.9   100-180

Lateral rotation
  AROM ([degrees])                    74.1    22.7    20-70
  PROM ([degrees])                    82.5    16.9    40-70

Medial rotation
  AROM ([degrees])                    52.8    22.8    20-70
  PROM ([degrees])                    74.1    17.2    40-70

Extension
  AROM ([degrees])                    45.6    11.5    30-65
  AROM ([degrees])                    56.8     6.3    45-65

HAQ                                    1.2     0.5   0.6-2.5

SDQ                                   75.0    11.8    40-100

                                       Sham-Ultrasound
                                        Group (n=16)

                                      After Intervention

                                    [bar
Variable (a)                        .X]     SD      Range    P

Pain rating (on 0-3 Likert scale)
  At rest                             1.3    0.4     1-2     .007 (b)
  With motion                         2.1    0.2     2-3     .001 (b)

Flexion
  AROM ([degrees])                  160.3   12.0   140-180   .0001 (b)
  PROM ([degrees])                  172.8   10.3   150-180   .0001 (b)

Abduction
  AROM ([degrees])                  162.2   16.7   120-180   .001 (b)
  PROM ([degrees])                  174.4   10.7   140-180   .001 (b)

Lateral rotation
  AROM ([degrees])                   87.8    5.4    60-70    .012 (b)
  PROM ([degrees])                   89.3    2.5    70-70    .066

Medial rotation
  AROM ([degrees])                   72.2   13.4    50-70    .001 (b)
  PROM ([degrees])                   88.1    7.5    60-70    .007 (b)

Extension
  AROM ([degrees])                   57.2    7.9    45-65    .001 (b)
  AROM ([degrees])                   60.3    6.1    50-70    .01 (b)

HAQ                                   0.4    0.2   0.1-0.8   .0001 (b)

SDQ                                  38.2   15.6     4-73    .0001 (b)

(a) AROM=active range of motion, PROM=passive range of motion,
HAQ=Health Assessment Questionnaire, SDQ=Shoulder Disability
Questionnaire.

(b) Statistically significant difference (statistical level of
significance: .05, Wilcoxon signed ranks test).

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

                                    True-Ultrasound Group
                                    (n=17)

                                    Preintervention-
                                    Postintervention
                                    Difference

Variable (a)                        [bar.X]   SD      Range

Pain rating (on 0-3 Likert scale)
  At rest                               0.7     0.4     0-1
  With motion                           0.4     0.5     0-1
Flexion
  AROM ([degrees])                     29.4    23.6     0-70
  PROM ([degrees])                     22.9    20.1     0-60
Abduction
  AROM ([degrees])                     44.1    24.6    10-90
  PROM ([degrees])                     33.2    22.7     5-80
Lateral rotation
  AROM ([degrees])                     15.5    16.9     0-50
  PROM ([degrees])                      7.4    12.0     0-40
Medial rotation
  AROM ([degrees])                     24.4    17.1     0-70
  PROM ([degrees])                     14.7    16.1     0-60
Extension
  AROM ([degrees])                     10.0     8.4     0-25
  PROM ([degrees])                      4.1     6.6     0-25
HAQ                                     0.6     0.5   0.1-2.3
SDQ                                    34.5    19.0     1-12

                                    Sham-Ultrasound Group
                                    (n=16)

                                    Preintervention-
                                    Postintervention
                                    Difference

Variable (a)                        [bar.X]   SD      Range     p (b)

Pain rating (on 0-3 Likert scale)
  At rest                               0.5     0.6     0-2      .36
  With motion                           0.6     0.4     0-1      .21
Flexion
  AROM ([degrees])                     36.5    25.5     5-90     .39
  PROM ([degrees])                     23.7    16.4     5-60     .87
Abduction
  AROM ([degrees])                     48.7    29.9     0-100    .65
  PROM ([degrees])                     32.8    26.3     0-80     .85
Lateral rotation
  AROM ([degrees])                     13.7    18.3     0-50     .69
  PROM ([degrees])                      6.8    15.3     0-50     .45
Medial rotation
  AROM ([degrees])                     28.7    17.3     0-55     .28
  PROM ([degrees])                     14.1    16.0     0-50     .79
Extension
  AROM ([degrees])                     11.5     8.1     0-25     .55
  PROM ([degrees])                      3.5     6.2     0-25     .82
HAQ                                     0.8     0.5   0.2-2.3    .27
SDQ                                    36.7    18.1     1-12     .71

(a) AR0M=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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* Petas, Ankara, Turkey.

([dagger]) Parker Laboratories The, 286 Eldridge Rd, Fairfield, NJ 07004.

([double dagger]) EMS, Oxfordshire, United Kingdom.

Y Kurtais Gursel, MD, is Assistant Professor, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, University of Ankara, Ankara, Turkey. Address all correspondence to Dr Kurtais Gursel at Sedat Simavi Sok, MESA 6.Blok 37/32 Cankaya, Ankara, Turkey (ykurtais@ttnet.net.tr).

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

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

G Dincer, 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 Kurtais Gursel and Dr Dincer provided concept/idea/research design. Dr Kurtais Gursel and Dr van der Heijden provided writing. Dr Kurtais Gursel, Dr Ulus, and Dr Bilgic provided data collection, and Dr Kurtais Gursel provided data analysis. Dr Kurtais Gursel, Dr Ulus, Dr Bilgic, and Dr Dincer provided subjects. Dr Kurtais Gursel and Dr Dincer provided project management. Di Kurtais Gursel and Dr Ulus provided facilities/equipment. Dr Dincer 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 ethics committee A multidisciplinary hospital body composed of a broad spectrum of personnel–eg, physicians, nurses, social workers, priests, and others, which addresses the moral and ethical issues within the hospital. See DNR, Institutional review board.  of the Ibn-i Sina Hospital, University of Ankara.

This article was received December 30, 2002, and was accepted October 20, 2003.
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Title Annotation:Research Report
Author:van der Heijden, Geert JMG
Publication:Physical Therapy
Geographic Code:1USA
Date:Apr 1, 2004
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