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Effects of Acupuncture Versus Ultrasound in Patients With Impingement Syndrome: Randomized Clinical Trial

KM Johansson, PT, PhD, is Lecturer, Physical Therapy Program, Department of Health and Society, Primary Care, Linköpings Universitet, S-581 83, Linköping, Sweden (Kajsa.Johansson{at}ihs.liu.se)
LE Adolfsson, MD, PhD, is Associate Professor, Department of Neuroscience and Locomotion, Orthopedics and Sports Medicine, Linköpings Universitet
MOM Foldevi, MD, PhD, is Associate Professor, Department of Health and Society, Primary Care, Linköpings Universitet

Address all correspondence to Dr Johansson

Submitted February 5, 2004; Accepted November 19, 2004

	Abstract

 
Background and Purpose. There is no definitive evidence for the efficacy of the physical therapy interventions used for patients with impingement syndrome. The purpose of this study was to compare manual acupuncture and continuous ultrasound, both applied in addition to home exercises, for patients diagnosed with impingement syndrome. Subjects and Methods. Eighty-five patients with clinical signs of impingement syndrome were randomly assigned to either a group that received acupuncture (n=44) or a group that received ultrasound (n=41). Both interventions were given by physical therapists twice a week for 5 weeks in addition to a home exercise program. Scores from 3 shoulder disability measures, combined in the analysis, measured change during a period of 12 months. Results. Both groups improved, but the acupuncture group had a larger improvement in the combined score. Discussion and Conclusion. The results suggest that acupuncture is more efficacious than ultrasound when applied in addition to home exercises.

Key Words: Family practice • Home exercise program • Physical therapy • Rotator cuff • Subacromial pain

	Introduction

Top Abstract Introduction Method Results Discussion and Conclusion Appendix 1 Appendix 2 References

 
Impingement syndrome is one of the most common diagnoses of patients with shoulder problems. A prevalence of 7% has been reported in a Swedish population.¹ In Dutch general practice, about 48% of patients who consulted a general practitioner for shoulder problems were diagnosed with impingement syndrome,² and this condition is reported to be persistent.³

In the current study, the term "impingement syndrome" is used. Patients with this syndrome experience pain in the deltoid muscle area, especially during arm elevation. Different maneuvers compressing the subacromial bursa and the supraspinatus muscle between the acromion and the humeral head can be used to reproduce this pain.^4,5

Controversy exists about the pain-generating mechanisms in patients with impingement syndrome. In theory, pain from the subacromial structures can occur from extrinsic mechanical wear or compression from the coracoacromial arch, but there also may be intrinsic causes such as degenerative changes in the rotator cuff.⁶

These patients often receive different kinds of physical therapy interventions,⁷ but there is no definitive evidence that physical therapy interventions are efficacious for patients with impingement syndrome.^8,9 The interventions chosen in our study—acupuncture, ultrasound, and home exercises—are commonly used interventions among physical therapists in Swedish primary care.^7,10 Acupuncture has been used by physical therapists in Sweden since the mid-1980s,¹¹ a more recent treatment alternative than ultrasound. Before the start of this study in 1997, two reviews had expressed doubt about the efficacy of therapeutic ultrasound for musculoskeletal disorders.^12,13 The most common strategy of physical therapists is to use a combination of interventions. Furthermore, there is a strong need for studies on existing physical therapy interventions.¹⁴ Because both acupuncture and ultrasound are common interventions, often used in combination with exercises, and have a similar treatment setup, it seemed reasonable to compare them in this clinical trial.

The purpose of our study was to evaluate and compare the efficacy of 2 physical therapy strategies for patients with impingement syndrome: (1) acupuncture applied in addition to home exercises and (2) continuous ultrasound therapy applied in addition to home exercises. Using previously published instruments, the outcomes were measured during a period of 12 months.

	Method

Top Abstract Introduction Method Results Discussion and Conclusion Appendix 1 Appendix 2 References

 
A prospective, observer-blind, randomized clinical trial was conducted.

Subjects

The subjects were recruited from 3 urban primary health care centers in the county of Östergötland, Sweden, from March 1997 to June 2000. Patients with shoulder pain who contacted the general practitioners or physical therapists at these primary health care centers were offered an encounter with the research physical therapist (KJ) if they were between 30 and 65 years of age. The general practitioners and physical therapists were instructed to recruit patients with clinical signs of a probable impingement syndrome, described as pain during abduction and pain located in the proximal lateral aspect of the upper arm.

Potential participants underwent a standardized clinical examination performed by the research physical therapist. At the inclusion visit, background data on age, sex, duration, occupation related to arm load, leisure activities, smoking, and medical history were documented. The history included description of symptoms and pain location, duration of current episode, circumstances at onset of pain, pain related to rest, night sleep and activities, recurrence or a first-time problem, medication, and sick leave. The complete set of inclusion and exclusion criteria is shown in Figure 1.

View larger version (39K): [in this window] [in a new window] Figure 1. Inclusion and exclusion criteria.

Of the 173 patients who visited the research physical therapist, 88 were diagnosed as having impingement syndrome and fulfilled the other inclusion criteria. Three of these patients did not enter the study, one due to working conditions, one because of a fear of needles, and one because of a myocardial infarction that occurred between the inclusion visit and the start of interventions. The affected shoulder of the remaining 85 patients was radiologically examined to exclude malignancy, osteoarthritis of the glenohumeral joint, and skeletal abnormalities. Standard anteroposterior and lateral projections were taken as well as a special projection of the acromioclavicular joint. None of the patients were excluded on the basis of the radiographs. Accordingly, 85 patients entered the study and were randomly assigned to either a group that received acupuncture combined with home exercises (n=44) or a group that received continuous ultrasound combined with home exercises (n=41).

Concealed randomization, based on a random list, with the treatment alternative in envelopes was carried out beforehand. The intervention was then introduced and performed by 4 physical therapists at the same primary health care center. All of the physical therapists were experienced and had worked in primary care for at least 12 years. In Sweden, acupuncture was approved in 1984 by the Swedish National Board of Health and Welfare to be used by registered medical professions after additional training.¹¹

Procedure

The acupuncture group received 10 treatment sessions. The physical therapists used standardized needle placement at 4 local points (LI 14 [Binao], LI 15 [Jianyu], LU 1 [Zhongfu], and TE 14 [Jianliao]) and one distal point (LI 4 [Hegu]) (Appendix 1). All points were chosen in accordance with current practice, and, before starting the study, all physical therapists were trained to locate these points. The depth and angle of needle insertion were those described in a Swedish manual.¹⁶ The type of needle used was a HEGU^* sterile and single-packaged one-time needle no. 8 (30 mm long and 0.30 mm in diameter). The treatment was repeated twice a week for 5 weeks, and each treatment session lasted 30 minutes. The patients lay on a treatment table on their unaffected side. After insertion into the defined points, the needle was rotated a few seconds until "de qi" was experienced by the patient. De qi is often described by patients as a sensation of heaviness, numbness, and radiating paresthesia.¹¹ It is believed to be a sign of the activation of the descending pain inhibitory systems, and opioid peptides are released, especially by the midbrain periaquaductal grey.^17,18 In total, 3 stimulations were performed (ie, at insertion and after 15 and 30 minutes). De qi was to be experienced at every stimulation at each acupuncture point, if not the needle was adjusted until this was the case.

The ultrasound group received continuous ultrasound twice a week for 5 weeks (10 treatment sessions). Each session lasted 10 minutes, and a standardized mode (frequency=1 MHz, spatial-average intensity=1 W/cm², gel coupling) was used. The size of the transducer was 4 cm², and the skin area treated was twice this size, covering an area of about 8 to 10 cm² inferior to the anterior and lateral part of the acromion. The transducer head was moved in small circles covering the area.¹⁹ The patients were seated with the glenohumeral joint extended and medially rotated in order to make the muscle insertion of the supraspinatus muscle appear beneath and anterior to the acromion.²⁰ This joint position was maintained by placing the arm behind the back of the chair. The equipment used was a Phyaction 190 ultrasound device. The same equipment was used for all patients, and it was tested by an independent medical technician before starting the study and then once every 12 months. No recalibration was needed during the study.

Both interventions were combined with a 2-step home exercise program developed in and based on clinical practice as well as supported by research.²¹ The chosen exercises in the first part of the exercise program were targeted to maintain or restore motion as well as to stimulate circulation in the rotator cuff using many repetitions of low-intensity exercises, without provoking pain from the involved tissues. In the second part of the exercise program, the target was to strengthen the rotator cuff muscles with the upper arm in a neutral position to avoid impingement. In all exercises, the position of a retracted shoulder was emphasized, in line with the findings of Solem-Bertoft et al,²² where a protracted shoulder resulted in a narrowing of the anterior aspects of the subacromial space. Appendix 2 gives detailed descriptions of all of the exercises in the program.

At the first treatment visit, the patients received instructions from the physical therapist and practiced the exercises in part one of the program. They were instructed to perform the program daily for 5 weeks. After the first half of the treatment period, the patients received instruction and practiced the second part of the exercise program. All rotations were performed with a pillow in the axilla to decrease the activity in the deltoid muscle. The exercises were to be done every other day during the fourth and fifth weeks. Pain during the exercises was not to last more than 10 to 15 minutes after the program. If pain persisted longer than that, the patients were instructed to decrease either the resistance or the force produced. Adherence to the exercise program was monitored by a home exercise adherence log, and the use of additional medications was reported.

Outcome Measures

The research physical therapist, who performed the examinations and all assessments, was uninformed of treatment group assignments throughout the study. The same clinical examination (the Neer impingement test excluded), with the same assessment instruments, was repeated the week after the period of acupuncture or ultrasound was completed and 3, 6, and 12 months from the date of the initial visit. At each visit after the inclusion, current symptoms and differences from baseline were documented.

During the planning of the study in 1996, there was no consensus about which instrument should be used when assessing patients with impingement syndrome. This uncertainty and the decision of the European Society for Surgery of the Shoulder and Elbow²³ that the Constant-Murley Shoulder Assessment (CM Score)²⁴ should be used in all research involving patients with shoulder problems led to the choice of using 3 disease-specific shoulder assessment scales: the CM Score, the Adolfsson-Lysholm Shoulder Score (AL Score),²⁵ and the University of California at Los Angeles End-Result Score (UCLA Score).²⁶ All 3 scales were used at baseline and at each assessment visit. Their variables are described in more detail in Table 1.

The AL Score was chosen because it was developed for patients with impingement syndrome.²⁵ With respect to test-retest factors, we recently evaluated intraobserver reliability for the AL Score and found it to be stable over time for patients with impingement syndrome (unpublished data). Thirty-five patients with impingement syndrome of at least 2 months' duration completed the score twice. The interval was 3 to 7 days, and the score was repeated at the same time of the day. None of the patients received any intervention during the study, and, if they used medication for their symptoms, they were instructed to maintain the same level. The results were analyzed with a repeated-measures analysis of variance (ANOVA). The intraclass correlation coefficient for the total score was .91.

Data Analysis

All patients were adherent to the study protocol (no missed or additional interventions) during the 5 weeks of acupuncture or ultrasound. At the 3-, 6-, and 12-month visits, the number of patients who were adherent to the study protocol changed, as shown in Figure 2. In total, 64 patients were adherent to the study protocol throughout the study. The data were analyzed both for the group adhering to the study protocol and with an "intention-to-treat" (ITT) application model for analysis of data for clinical trials.²⁷ The latter analysis included all patients who were randomly assigned to groups. The principle of last observation carried forward (LOCF) was used in both analyses, using the scores recorded just prior to the missing scores in case of missing posttreatment values.²⁷ The number of patients where LOCF was used is illustrated in Figure 2.

View larger version (21K): [in this window] [in a new window] Figure 2. Flow chart of the sample during the study (with the number where last observations carried forward has been used in parentheses).

In the data analysis, we have chosen to combine the scores for the 3 outcome measures, using the mean of the 3 outcome measures' total scores. The maximum of 35 points for the UCLA Score and of 100 for the CM Score and the AL Score was corrected by multiplying the UCLA Score by 100 and then dividing by 35.

To compare background variables between the 2 treatment groups, we used a Student t test for continuous data, a chi-square test for categorical data, and a Mann-Whitney U test for ordinal data. A repeated-measures ANOVA was used to analyze the change in the combined shoulder disability score over time within the treatment groups. To compare the outcome between the groups, we used a general linear model analysis of covariance (ANCOVA) for repeated measures. The combined shoulder disability score at all 4 visits after the 5 weeks of acupuncture or ultrasound served as the dependent variable, and the starting score was the covariate. This analysis was chosen to adjust for the difference in baseline score between the groups. The level of statistical significance for all testing was P<.05.

	Results

Top Abstract Introduction Method Results Discussion and Conclusion Appendix 1 Appendix 2 References

 
Before treatment, there were no differences in the background variables between treatment groups (Tab. 2). No adverse effects or side effects were reported in either group during or after the treatment period. Nine patients in the acupuncture group and 8 patients in the ultrasound group received additional treatment. These 17 patients were consequently not adhering to the study protocol, and their data were included in the ITT analyses.

There were no differences in adherence to home exercises or in use of additional pain medication between the treatment groups. The number where LOCF was used was similar in both groups. The scores of the patients for whom LOCF was used did not appear to differ from the other patients.

Both treatment groups' mean scores at baseline and at each assessment visit are presented in Table 3. There were no differences between the treatment groups' mean scores at baseline. Both treatment groups improved during the study (P<.0001, ANOVA).

View larger version (13K): [in this window] [in a new window] Figure 3. Presentation of the mean in the combined score at each visit for the 2 treatment groups, including all patients who adhered to the study protocol (n=64). Between-group difference analyzed with analysis of covariance (P=.045).

	Discussion and Conclusion

Top Abstract Introduction Method Results Discussion and Conclusion Appendix 1 Appendix 2 References

The magnitude of the treatment effect is unknown in the absence of a true control group. To our knowledge, no earlier study has dealt with the natural course of impingement syndrome. For unspecified shoulder pain, however, Ginn et al³⁰ reported no improvement after 1 month without treatment, and Macfarlane et al³¹ described persistent disabling problems after 3 years.³⁰ The outcome illustrated in Figure 3 is probably a combination of a treatment effect and the natural course.

In our view, the patients selected for our study were representative of the general population seeking care for this type of shoulder problem. With a few exceptions, all referrals came from general practitioners and physical therapists in primary care, and this should avoid the risk of studying a highly selective group (eg, patients from a sports or surgical clinic).

The analysis of the group adhering to the protocol in this study was used to evaluate the efficacy of the studied interventions, and the ITT analyses were used to examine the overall benefits of interventions in primary care. When interpreting the results, physical therapists should be aware that, although the patients included in this study had a more specific diagnosis than a group of patients with shoulder pain, there still could be other reasons than subacromial reasons for their pain and disability.

The maneuvers used for inclusion in our study have been reported to compress the structures of interest.³² Some authors³³ have reported how the subacromial pressure increases during the impingement sign test. High sensitivity has been reported for Neer impingement sign test (75%–89%^34,35) as well as for Hawkins-Kennedy impingement sign test (88%–92%^34,35), but their specificity is lower (Neer impingement sign test: 31%–51%; Hawkins-Kennedy impingement sign test: 25%–44%^34,35), which lessens their discriminative ability. The sensitivity for the Neer impingement sign test has been reported to be 70% to 83%.^36,37 This diagnostic injection test has been used in earlier research as the gold standard for identifying impingement syndrome.³⁴ In our study, it was used as a compulsory criterion, but in combination with other findings to increase its positive predictive value. In a recent review,³⁸ the inclusion criteria used in our study were reported as proper and the exclusion criteria as adequate because they control for conditions interfering with a successful outcome of treatment for patients with impingement syndrome. Despite a lack of certainty about what diagnostic tests should be used, we believe that the chosen combination of inclusion and exclusion criteria was sufficient for identifying a group of patients with impingement syndrome. Still, it is difficult to state whether or not there is a partial rupture of the rotator cuff, which could explain why some patients had less improvement than other patients.

Our choice to emphasize the importance of selecting interventions with similar setups as well as the use of a standardized treatment protocol is supported by the recent published CONSORT statement.³⁹ The conclusion in our earlier review that ultrasound is ineffective,¹⁰ together with Kurtaiü Gürsel and colleagues' conclusion that ultrasound had no effect as additional treatment to physical therapy interventions,⁴⁰ may imply that this study compared home exercises with and without acupuncture.

The exercises used in our study were similar to those reported as efficacious in earlier studies.^41,42 The chosen exercise involving external rotation, with fixed elbows using a tube, has been reported to result in the highest activation of the infraspinatus muscle, a muscle that is important to strengthen in patients with impingement syndrome.⁴³ Ginn et al³⁰ reported that strengthening exercises and motor retraining were superior to no intervention for patients with shoulder pain. The repeated clinical examination at each assessment visit has a methodological advantage over follow-ups with scores mailed to the patients because bias from changing diagnoses over time can be avoided.⁴⁴

Limitations of the Study

The major limitation concerns the instruments used for the outcome measure. Because all 3 measures have indeterminate measurement properties, we chose to use the mean of the 3 total scores, mainly to make the reporting of results less complicated than if all scores from all visits should be presented separately. This procedure decreased the variability and thus increased the power in the statistical analysis, but the sensitivity for change probably decreased, with a possible underestimation of the real effect. However, there is still an uncertainty about the instruments' qualities. The differences between the groups were small compared with the overall effect over time, but the differences that we found corresponded to 1 to 2 steps in the outcome scales (eg, 5 points corresponds to having or not having disturbing nightly pain that interferes with sleep, a difference we regard as clinically significant).

Another aspect when interpreting the results from this study is that the influence of psychosocial factors is unknown, because no instrument covering this area was used. To our knowledge, this is the first randomized clinical trial involving patients with impingement syndrome and comparing acupuncture and ultrasound, both combined with a home exercise program. The larger improvement in the acupuncture group, which was seen at the first assessment visit and maintained over time, indicates that a physical therapy strategy with a combination of acupuncture and home exercises is more beneficial for most patients with impingement syndrome. This conclusion is supported by our recent review,¹⁰ where tentative evidence was found for the short-term efficacy of acupuncture and strengthening exercises. Furthermore, we concluded in that review that therapeutic ultrasound was ineffective in these patients.¹⁰ In conclusion, acupuncture is advocated before ultrasound, in addition to home exercises, for patients with impingement syndrome.

	Appendix 1

Top Abstract Introduction Method Results Discussion and Conclusion Appendix 1 Appendix 2 References

 

View larger version (30K): [in this window] [in a new window] Appendix 1. Description of Placement of the Acupuncture Needles

	Appendix 2

Top Abstract Introduction Method Results Discussion and Conclusion Appendix 1 Appendix 2 References

View larger version (269K): [in this window] [in a new window] Appendix 2. Home Exercise Program

	Footnotes

 
All authors provided concept/idea/research design, writing, and project management. Dr Johansson provided data collection, and Dr Johansson and Dr Foldevi provided data analysis and fund procurement. Dr Adolfsson and Dr Foldevi provided subjects. The authors acknowledge statisticians John Carstensen, Mats Fredrikson, and Olle Eriksson for statistical consultation. Mr Jan Brandinger, Ms Karin Lindgren, Mr Christer Nilsson, and Mrs Gunilla Stålmarck are acknowledged for their work as physical therapists throughout the study. The authors also thank all participating patients and staff at the involved primary health care centers.

This study was approved by the Ethics Committee of the Faculty of Health Sciences at Linköpings Universitet.

This study was supported by funding and facilities provided by the County Council of Östergötland and Linköpings Universitet, Sweden.

^* Svenska AB, PO Box 89, SE–570 12 Landsbro, Sweden.

Uniphy, PO Box 558, NL–5600 Eindhoven, the Netherlands.

	References

Top Abstract Introduction Method Results Discussion and Conclusion Appendix 1 Appendix 2 References

 

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