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Subacromial corticosteroid injection or

acupuncture with home exercises when treating

patients with subacromial impingement in

primary care-a randomized clinical trial

Kajsa Johansson, Anna Bergström, Karin Schröder and Mats Foldevi

Linköping University Post Print

N.B.: When citing this work, cite the original article.

This is a pre-copy-editing, author-produced PDF of an article accepted for publication in Family Practice following peer review. The definitive publisher-authenticated version:

Kajsa Johansson, Anna Bergström, Karin Schröder and Mats Foldevi, Subacromial corticosteroid injection or acupuncture with home exercises when treating patients with subacromial impingement in primary care-a randomized clinical trial, 2011, Family Practice, (28), 4, 355-365.

is available online at: http://dx.doi.org/10.1093/fampra/cmq119 Copyright: Oxford University Press (OUP)

http://www.oxfordjournals.org/

Postprint available at: Linköping University Electronic Press http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-69983

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Subacromial corticosteroid injection or acupuncture with home-exercises when treating patients with subacromial impingement in primary care – a randomised clinical trial

Running title: Subacromial corticosteroid injection or acupuncture with home-exercises for

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Abstract

Background: Patients with subacromial impingement syndrome (SIS) commonly seek primary care. Subacromial corticosteroid injection is the standard treatment given by general practitioners, which is supported by earlier studies reporting a positive effect but inconclusive evidence over the long term. In Sweden, physiotherapists often choose acupuncture combined with exercises to treat SIS, which was reported as probably efficacious.

Objective: To compare the efficacy of subacromial corticosteroids injected by a general practitioner with physiotherapy combining acupuncture and home-exercises as treatments for SIS.

Methods:

A randomised clinical trial was performed in primary health care. Patients diagnosed with SIS were randomised to either subacromial corticosteroid injection (s) or ten acupuncture treatments combined with home exercises. The main outcome was pain and shoulder function (Adolfsson-Lysholm shoulder assessment score). Secondary outcomes were health-related quality of life (EuroQol 5D self report questionnaire) and the patients’ global assessment of change. All patients were assessed at baseline and after 6 weeks and 3, 6, and 12 months.

Results: One hundred seventeen patients with SIS were included, of which 91 complied with the study protocol. There were no significant differences between treatments with regard to pain, shoulder function, and health-related quality of life in change over time. However both treatment groups improved significantly from baseline over time.

Conclusion: Both subacromial corticosteroid injection and a series of acupuncture treatments combined with home-exercises significantly decreased pain and improved shoulder function in patients with SIS, but neither treatment was significantly superior to the other.

Keywords: Subacromial impingement syndrome, rotator cuff, physiotherapy, corticosteroids, acupuncture.

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Introduction

Patients with shoulder disability caused by subacromial pain are commonly seen in primary care1. About 48% of patients consulting a Dutch general practitioner (GP) for shoulder problems were diagnosed with impingement syndrome,1 and a 7% prevalence of subacromial pain has been reported in a Swedish middle-aged population.2

In the current study, the term 'subacromial impingement syndrome' (SIS) is used and includes patients diagnosed with rotator cuff tendinosis and subacromial bursitis. Different manoeuvres, compressing the subacromial bursa and different parts of the rotator cuff between the acromion and the humeral head, are used to reproduce symptoms.3,4

GPs often use subacromial corticosteroid injections5 to treat patients with SIS. A Cochrane review6 concluded that subacromial corticosteroid injection had a small benefit over placebo in the short-term, and addressed the need for additional well-designed trials with longer follow-ups. A later review including articles published up to 2004 supported the conclusion of the Cochrane review.7 However, a critical systematic review by Koester et al8 that included articles up to January 2006 concluded that subacromial corticosteroid injections are inefficient for patients with rotator cuff disease. Only a limited number of studies have compared subacromial corticosteroid injection with a physiotherapy (PT) intervention. Hay et al9 reported similar efficacy for subacromial corticosteroid injection and a mix of PT intervention and it is common in clinical practice to combine for example acupuncture with exercises as a treatment for patients with SIS.5,10 Electro11 and manual acupuncture12 alone or combined with home exercises13 are reported as being probably effective, but the treatment strategies and inclusion criteria of different trials has varied. Overall, the evidence of efficacy seems inconclusive, especially over the long-term. Therefore, which treatment to recommend for patients with SIS in the primary care remains an unanswered question.

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patients with SIS performed by different primary care professionals: (1) subacromial injection of corticosteroids (by a GP), and (2) a series of manual acupunctures (by a PT) combined with home-exercises.

The study was designed to determine if one of the treatments is significantly superior in decreasing pain and improving shoulder function (H1), measured on a single dimension score using the Adolfsson-Lysholm shoulder assessment.

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Methods

A randomised clinical trial of 12 months of follow-up was conducted at five primary health care centres (PHCC) in south-eastern Sweden during 2004 to 2007. In the participating county councils the patients had direct access to GPs and PTs (approved by the Swedish National Board of Health and Welfare). Patients aged between 30 and 65 years, who presented at the PHCC (either a GP or a PT consultation) with shoulder pain located in the deltoid area provoked by elevation of the arm, were offered a visit with the research PT. Patients with less duration than two months were excluded because of a probable high degree of spontaneous recovery and if consulting for acute subacromial bursitis the standard treatment is a corticosteroid injection. If the patients were diagnosed with SIS and fulfilled the inclusion criteria (Appendix 1), they received oral and written information about the study and gave their informed consent to participate.

Procedure for diagnosis and inclusion

All potential participants were examined with a standardised clinical procedure performed by one of two research PTs. At the inclusion visit, age, sex, duration, work-load, sick-leave, and medical history were documented. The complete list of inclusion and exclusion criteria is presented in Appendix 1.

First, manoeuvres to provoke the subacromial tissues were performed; these included the Neer impingement sign3 and the Hawkins-Kennedy impingement test4. Patients diagnosed with SIS had a final test for inclusion, the Neer impingement test as described by Neer and Welsh3. A local anaesthetic consisting of 10 mL prilocaine (10 mg/mL) was injected by a GP with the patient seated. A posterio-lateral injection approach with the needle entering the subacromial space was used14. Then the manoeuvres to provoke the subacromial structures were repeated after 10–15 minutes. The Neer impingement test was considered positive if there was clearly pain relief. If not, the manoeuvres were repeated after another 20 minutes.

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Randomization

The patients that agreed to participate were randomly allocated to either a corticosteroid injection or acupuncture combined with home-exercises. For allocation of the participants, a computer-generated list of random numbers was used by the study-coordinator, who was not involved in the treatments or assessments. The treatment alternative was placed in envelopes, numbered in accordance with the randomisation list, and concealed. An independent PHCC-employee consequently revealed the allocation and made an appointment with either a GP or a PT, accordingly. All clinicians (three GPs and three PTs) involved in treatment were blinded to the assessments performed by the research PTs during the study and vice-versa.

Interventions

Corticosteroid group: The patients were assigned to a GP within one week of inclusion for an injection of 1 ml Depomedrone (40 mg methylprednisolone) + 8–10 ml of 1% Prilocaine. A posterior approach with a 21 G. x 20.80 x 50 millimetre needle (Sterican, B. Braun

Melsungen AG) was used as a standard14. The posterior approach is identified 2 cm distal and 1 cm medial to the posterio-lateral tip of the acromion. The needle is angled approximately 45° cephalad to follow the contour of the posterior acromion. After the injection, the patients were then advised to refrain from heavy arm activities for the next two weeks. After this, patients were allowed to return to normal activities but advised to avoid activities that clearly provoked impingement. They were also informed that if the first injection would result in a doubtful effect the patients could get a second injection by contacting the treating GP.

Acupuncture group: The patients started manual acupuncture in addition to a home-exercise program within one week of inclusion. The treating PT used standardized needle placement in defined acupuncture points; the location, depth and angle of each needle insertion are described in Appendix 2. All PTs were pre-trained on how to locate identical points on all patients. The type of needle used was a HEGU* (* HEGU, Svenska AB, P.O Box 89, SE –

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570 12 Landsbro, Sweden) sterile, single-packaged, one time use needle no. 8 (30 mm long and 0.30 mm diameter). The treatment was repeated twice weekly for five weeks, and each treatment session lasted 30 minutes. After insertion into the defined points, the needle was rotated (“stimulated”) a few seconds until “deqi” was experienced by the patient. This should not be a pricking or stinging sensation but could be a sensation like heaviness, numbness, pain and/or radiating paraesthesia; otherwise the needle was corrected since “deqi” has been reported as an sensation inducing different brain activities involved in the endogenous pain inhibition and influencing the experience of pain.15

In total, three stimulations were performed (immediately after needle insertion and again after 15 and 30 minutes).

The home-exercise program was a two-step program based on clinical practice and earlier efficacy research.13,16 The first part was targeted towards maintaining or restoring motion and to stimulate circulation in the rotator cuff using many low-intensity repetitions without

provoking pain from the tissues involved. The second part was targeted towards strengthening the rotator cuff with the arm in a neutral position to avoid impingement. All exercises are illustrated in detail in an earlier study13.

Outcome measures

Primary outcomes were pain and shoulder function and the secondary outcomes were health related quality of life (HRQL) and the patients’ global assessment of change. The assessments were performed at baseline then repeated after six weeks and three, six, and 12 months after the date of the initial visit. The research PTs, who performed all examinations and assessments, were blinded to the treatment group assignments throughout the study.

Pain and shoulder function were assessed with the Adolfssson-Lysholm shoulder assessment score (AL score).17 It has a maximum score of 100 points for no pain and no shoulder disability initially developed for patients with SIS. 17 It´s intra-observer reliability was found

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to be stable over time for patients with subacromial pain (unpublished data from a bachelor’s degree thesis in physical therapy at Linköping University, Sweden).

The EuroQol 5D self report questionnaire (EQ-5D) 18 was used to evaluate HRQL. This instrument has two parts; the EQ-5D descriptive system resulting in a health state between -1.0 (worst health) and 1.0 (full health) 19, and the EQ VAS. The later is a 20-cm vertical line from 0, “worst imaginable health state,” to 100, the “best imaginable health state,” and the patients mark their current state. Both parts werereported to be valid and reliable for self-assessed HRQL.20

At each follow up, the patients’ global assessment of change in symptoms because of the treatment was registered on a five-point ordinal scale with fixed alternatives; worse, unchanged, small improvement, large improvement, or recovered.

The patients were also screened for mental distress with the Hospital Anxiety and Depression Scale (HADS)21 to control for between-group differences at baseline, because this might influence the outcome.22 The scale was reported as being valid for primary care patients.23 A pre-study sample-size estimation, when comparing two-means (two-sided), resulted in a requirement of 54 patients in each group (β=.80, α=.05 two-sided). The expected difference between-groups was set to 15 points in the primary outcome (AL score) with a mean variability of 17. This variability was based on an earlier randomised clinical trial13 performed in the same setting with the same inclusion critera for diagnosis.

Statistical analyses

All patients who were compliant with the study protocol were included in the analysis of treatment efficacy, analysing both the primary and secondary outcomes. An alternative “intention-to-treat” (ITT) analysis application model for the analysis of data for clinical trials24 was also performed. The ITT analysis included patients who changed treatment groups during the study, but still continued their assessments per protocol.

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To compare demographic data between the two treatments groups, the Student t test was used for continuous data, a chi-square test for categorical data, and a Mann-Whitney U test for ordinal data. Change over time (in the AL score, EQ-5D, and EQ-VAS) within and between treatment groups was analyzed using analysis of variance (ANOVA) repeated measures design. The score at all assessments served as the dependent variable. The level of significance for all testing was p<.05 and 95% confidence intervals were used.

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Results

Baseline characteristics and completeness of participation

Figure 1 shows the study outline. Initially, 123 patients were enrolled and randomised, but six patients developed a frozen shoulder (see Appendix 1 for inclusion/exclusion criteria) during the next couple of weeks and were excluded from the study (explaining the different numbers of patients in each group, Figure 1). Overall, 117 patients fulfilled the criteria for the

diagnosis of SIS (Appendix 1) and all agreed to participate. They all were assessed at

baseline, received their allocated intervention, and were assessed again after 6 weeks. During the rest of the follow up assessments, some patients dropped-out or were non compliant. Finally, 91 patients were compliant and were included in the analysis of efficacy (Figure 1). Twenty six patients were non compliant with the study protocol for the following reasons: 13 were lost to follow-up and did not attend scheduled assessments, three missed assessments because of surgical referrals, eight changed treatment-group (ITT), and two declined further participation. The demographic data for these patients did not differ significantly with regard to baseline characteristics compared with patients who completed the study per protocol (table 1).

One fourth of the patients in the corticosteroid group (12 out of 49) had a second injection during follow-up and this has not been further analysed.

Suggested position for figure 1

Before treatment, there were no significant differences between the treatment groups with respect to background characteristics or baseline measures (Table 1). During the study, two patients in the corticosteroid group and five in the acupuncture group cancelled their 12-month assessment visit because they felt recovered. Fifteen other patients (ten in the corticosteroid group and five in the acupuncture group) missed one appointment during the follow-up and were unable to reschedule before the next assessment because of different

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circumstances. In these cases, the last observation carried forward was used.24 Suggested position for table 1

Treatment effects

The H1-hypothesis could not be verified. There were no significant differences in the primary outcome, pain and shoulder function measured by AL score (Table 2). Neither was there a difference in the secondary outcome, HRQL, between the treatment groups (Table 3).

However, both treatment groups reported a significant improvement over time regarding pain and shoulder function (p.001). The graphics in Figure 2 illustrates that both groups had a similar pattern in treatment response. HRQL improved significantly within the respective treatment groups (p.001) compared with baseline both for the EQ-5D descriptive system and EQ VAS.

Suggested position for figure 2

In general, the included patients had HADS scores with a low mean of 2.0 for depression in both groups, and 3.7 and 3.0 in the corticosteroid and acupuncture groups, respectively, for anxiety (Table 1). These scores remained almost unchanged during the study, and there were no significant differences between groups.

The global impression of change was in favour of the acupuncture group at the 6-month assessment (chi square p = .048). Thirty out of 42 (71%) patients rated large improvements or reported that they were recovered compared with 23 out of 47 (49%) patients in the

corticosteroid group. However, at the 12-month assessment there was no difference between treatments (chi square p = .16).

Suggested position for table 2

Similar results were found in the analysis of the ITT group, which included an additional eight patients, as in the per protocol group.

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At the 6-week assessment, the research PT asked the patients about adverse events. Only minor complications that were associated with the needle penetration were reported. If pain or a bruise occurred, it resolved in a couple of days. Tiredness, aggravation of existing

symptoms for a few days is defined as a common response to acupuncture treatment.25 Suggested position for table 3

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Discussion

Neither treatment was superior in decreasing pain and improving shoulder function. Both treatments showed a significant positive change in pain and shoulder function compared with baseline, as well as in HRQL, in primary care patients with SIS during a 12-month follow up. The long-term results are probably a combination of a positive treatment effect and the natural course of the disease. The latter is still unknown for patients with SIS.

Results and clinical reflections

The corticosteroid injection and acupuncture have an analgesic effect, which probably

explains part of the significant improvement in both groups from baseline, especially over the short term. Pain highly influences most patients´ ability to perform shoulder activities in everyday life, and decreased pain probably enhances the performance of the shoulder

muscles. If more correct muscle activation can be obtained around the shoulder, it is possible to improve centralization of the humeral head in the glenoid, which will decrease the risk of impingement and result in improved shoulder function.26

A limitation with the standardized home-exercise program was that it lacked individual progression of, for example, increased resistance for excessive muscle strength.27 A higher intensity and additional eccentric exercises28 might be even more effective.

Few earlier studies compare corticosteroid injections with different PT interventions. Similar to our results, Hay et al9 reported that both corticosteroid injections and PT treatment had a positive effect after six weeks, with a tendency towards favouring physiotherapy at the six-month assessment for patients with shoulder pain. They compared subacromial corticosteroid injections with different PT interventions using a pragmatic approach. Winters et al29

subcategorized patients with shoulder complaints and compared corticosteroid injection with manipulation or physiotherapy, and reported that corticosteroids were more effective in the short-term but equally effective after two to three years29,30 for patients categorized as “the

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synovial group,” which from the description could include patients with SIS. Contradictory to our results, Van der Windt et al31 favoured corticosteroids over physiotherapy in patients with unilateral shoulder pain. Improvements in pain and disability were assessed over 52 weeks. All of these studies had more imprecise inclusion criteria, which probably caused them to have more heterogeneous samples with different shoulder pathologies. Furthermore, use of the term physiotherapy without specifying its content, dosage, and progression makes comparisons with our results difficult.

Methodological strengths and considerations

We are aware that the study design, which involved randomising patients into one of two groups with active treatments, makes it impossible to conclude the size of the specific treatment effect. Inclusion of a third, placebo group would have been preferable.

The inclusion and exclusion criteria used in the study resulted in a patient population that was as homogenous as possible without using a MRI or a diagnostic ultrasound. This reflects the clinical encounter, but there are validity aspects to consider. The sensitivity of the manual tests for identifying SIS is greater than their specificity;32,33 therefore, it is possible that painful structures other than the subacromial bursa or the rotator cuff muscles are involved. The patients that dropped out of the study were similarly distributed in both treatment groups (Figure 1) and had similar baseline characteristics, and their inclusion in the analysis would probably not have had a major influence on the comparisons. The small differences between treatment groups (only five points at the most for the primary outcome [AL score]) at six months (Table 2) supports that even with a larger sample size, the null-hypothesis was unlikely to be rejected.

Another important factor to consider when interpreting the results is that the patient´s expectations and treatment preference can influence the self-assessed outcomes.34 Unfortunately, no preference data was noted and was not adjusted for during the

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randomization procedure. Furthermore, the number of treatments differed. The acupuncture group had ten visits whereas the corticosteroid group had only one, and it is possible that more visits could be a positive factor that played into a placebo effect.35 Alternatively, several consultations is more costly, and this aspect was not analysed in relation to treatment effect. Another important aspect was the accuracy of the corticosteroid injection, which has been discussed frequently in the literature. In the current study, a posterior approach was used, which is reported to have a higher accuracy rate than the anterior approach (76% versus 63%).36 The subacromial bursa was the target, but since no validation was performed with, for example, an ultrasonography, there is a risk that the intended structure was not infiltrated. On the contrary, the corticosteroid group had a clear response from baseline to six weeks

illustrated by the graphic change in Figure 2, which supports a response. Furthermore, a recent study reported that there were no differences in accuracy with or without guidance when the clinician was experienced.37 Also, the acupuncture group had a similar improvement from baseline to six weeks (Figure 2), which was interpreted as a result of the acupuncture analgesia. We are aware that the choice of acupuncture points might influence the magnitude of the effect and that the use of manual- or electro-acupuncture could make a difference in the underlying mechanism of analgesia.38

In conclusion, both treatments can be recommended for patients with SIS attending primary care facilities, and the choice could be influenced by the accessibility of the treatment and the individual patient’s preference. The strategies of treatment are described in detail and,

therefore, available for primary care clinicians to use in every day practice, which facilitates the transfer of these results. There is a need for future clinical research emphasizing the dose-response relationship of different exercises for patients with SIS. Co-operation between GPs and PTs (start with a corticosteroid injection and then suitable PT treatments) might lead to

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even better results. Future predictive studies are important to support clinical decision making for patients with SIS; who are likely to respond to corticosteroids and a specific exercise program in primary care, and who need a referral for orthopaedic surgery?

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Ethics approval

This study was approved by the Ethics Committee at the Faculty of Health Sciences, Linköping University, Sweden (approval no. 00-367).

Funding

This work was supported by the Medical Research Council of Southeast Sweden (F-2001-117, F2002-127, F2003-158) and with facilities provided by the county council of

Östergötland and Kalmar, and Linköping University.

Competing interests

This study was performed honestly, and no financial or other relationship exists that might lead to a conflict of interest.

Acknowledgements

The authors wish to thank the general practitioners and physiotherapists in the county council of Östergötland and Kalmar for the collaboration and the patients who participated to make this study possible.

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Figure legends

Figure 1 Study flow chart

Figure 2 Adolfsson-Lysholm shoulder assessment.17 The graph shows the improvement over time with the mean score and 95% confidence intervals (CI) at base-line and at each assessment. Analysis includes all patients who were compliant with the study protocol (n= 91). (100 points is maximum = no shoulder disability)

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References

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