Professional Assignment Project A systematic review.

Transcription

1 Amsterdam School of Health Professions European School of Physiotherapy Professional Assignment Project A systematic review. Students: Mary. M. Fonge & Courtney Smalley Coach: Cor Boelen

2 RESEARCH QUESTION How accurate are clinical tests in the diagnosis of primary shoulder impingement syndrome and how effective are exercise and manual therapy interventions in improving pain intensity, strength and functional loss in patients older than 16 years? 3

3 Mary. M. Fonge and Courtney Smalley European School of Physiotherapy Hva Tafelbergweg 51, 1156 BD Amsterdam January,

4 CONTENTS ABSTRACT... 7 GLOSSARY OF ABBREVIATIO... 8 DEFINITIO... 8 LIST OF TABLES... 9 INTRODUCTION METHODS AND MATERIALS Inclusion criteria Exclusion Search and selection process Data extraction and analysis Study selection Procedure in determining the diagnostic accuracy Methodological Quality assessment RESULTS Search results Quality of studies Quality of studies that evaluated the accuracy of clinical tests; Quality of studies on exercise and manual therapy intervention Diagnostic accuracy of clinical tests for subacromial impingement syndrome Diagnostic accuracy of clinical tests evaluating the integrity of rotator cuff tendons Effectiveness of therapeutic exercise and manual therapy in treatment of SIS DISCUSSION Diagnosis of SIS Discussions on treatment intervention articles Limitations of the study Implications for further research

5 CONCLUSION ACKNOWLEDGEMENT APPENDIX 1: CLINICAL TESTS WITH DIAGNOSTIC ACCURACY APPENDIX 2: CLINICAL TEST DESCRIPTION APPENDIX 3: PEDRO SCALE APPENDIX 4: QUALITY ASSESSMENT OF DIAGNOSTIC ACCURACY STUDIES REFERENCE:

6 ABSTRACT Background: Subacromial impingement of the rotator cuff tendon is the most frequent cause of shoulder pain and disability. The diagnosis of subacromial impingement syndrome (SIS) is often a challenge in clinical practice due to its broad spectrum of presentation. Moreover the signs and symptoms manifested by other shoulder pathologies are similar to those of SIS. Depending on the pathological stage of SIS, most patients will respond to conservative treatment. Purpose: A systematic review of diagnostic studies and of RCT s on intervention was conducted in order to determine the accuracy of clinical tests in the diagnosis of SIS and examine the effects of manual therapy and therapeutic exercises as treatment methods. Methods: A literature search was performed using the computerized databases PubMed, science Direct, Cochrane, PEDro, Medline, EMBASE and British Journal of sport Medicine. Two criteria lists- the PEDro scale and the QUADAS tools were used to assess the methodological quality of the selected articles. For diagnostic studies, data on sensitivity, specificity, PPV, NPV and LR s were extracted. For the intervention studies, data on intervention type, outcome measures and treatment effects were extracted. Results: The two component result (Diagnosis and treatment of SIS) was determined by summarizing and evaluating the data from the studies. A quantitative analysis of the results was performed. The LR S and predictive values were used to determine the diagnostic accuracy of clinical tests and levels of evidence was used to define the effectiveness of the treatment interventions. Conclusion: The diagnostic accuracy of individual clinical tests for the different stages of SIS was found to be low. The clinical tests can be used to rule in or rule out the presence of a rotator cuff lesion but a valid reference standard test is required to confirm the diagnosis. Strong evidence was found that combining manual therapy techniques with therapeutic exercises result in better improvements in pain intensities, strength and functional loss in SIS patients in short term follow-up compared to using exercise interventions alone Hogeschool van Amsterdam, All rights reserved. Keywords: Shoulder impingement syndrome, subacromial impingement syndrome, clinical tests, rotator cuff pathology, diagnostic accuracy, therapeutic exercise, manual therapy. 7

7 GLOSSARY OF ABBREVIATIO AMC: Academic Medical center CCT: Controlled clinical trial DASH: Disabilities of the Arm, shoulder and Hand. : Full thickness tears PPV: Positive predictive value NPV: Negative predictive value : Not stated LR: Likelihood ratio LR+: Positive likelihood ratio LR- : Negative likelihood ratio PTT: Partial thickness tears QUADAS: Quality Assessment of Diagnostic Accuracy Studies RCT: randomized controlled trials SIS: Subacromial impingement syndrome SDR: Shoulder rating questionnaire. SPADI: Shoulder pain and disability questionnaire. VAS: Visual analogue scale. PEDro: Physiotherapy Evidence Database SRQ: Shoulder rating questionnaire VU: Vrije Universiteit. UvA: Universiteit van Amsterdam. DEFINITIO Sensitivity: Proportion of patients who have the outcome who are classified as having a positive result. Specificity: Proportion of patients without the outcome who are classified as having a negative result. PPV: Probability that a patient for whom the test is positive actually has the pathology. NPV: Probability that a patient for whom the test is negative actually does not have the pathology. Likelihood ratios describe how many times a person with the pathology is more likely to receive a positive or negative test result than a person without disease. Positive likelihood ratio expresses how much more likely the positive test result is to occur in subjects with the disease compared to those without the disease. The higher the LR+, the more certain that a positive test indicates the person has the disorder. Negative likelihood ratio represents the ratio of the probability that a negative result will occur in subjects with the disease to the probability that the same result will occur in subjects without the disease. The lower the negative LR, the more certain that a negative test indicates the person does not have the disorder. 8

8 LIST OF TABLES page Table 1: Levels of evidence.10 Table 2: Summary of selected studies on clinical test evaluation and diagnosis of SIS..11 Table 3: Summary of selected articles reporting on the treatment interventions for SIS 13 Table 4: Performance characteristics of clinical tests for SIS 14 Table 5: Performance characteristics of combination tests for SIS...15 Table 6: Performance characteristics of supraspinatus tests.17 Table 7: Performance characteristics of subscapularis tests...18 Table 8: Performance characteristics of infraspinatus tests...19 Table 9: Performance characteristics of tests for the long head of the biceps tendon.19 Table 10: Performance characteristics of clinical tests for subacromial bursitis...20 Table 11: Performance characteristics of combination tests for subacromial bursitis.20 Table 12: Results of therapeutic exercise and manual therapy interventions for SIS..21 9

9 INTRODUCTION Shoulder pain is classified as the third most common musculoskeletal complaint in the general population and accounts for 5 of all musculoskeletal consults (Urwin et al. 1998). The cumulative incidence of shoulder problems was estimated at 18/0 patient cases per year in Dutch general practice (van der Windt et al. 2004). According to Michener et al. (2004) the most frequent cause of shoulder pain is subacromial impingement syndrome as it accounts for 44 to 60 of all shoulder complaints. Primary shoulder impingement / subacromial impingement or external impingement syndrome is a painful condition which is caused by the mechanical encroachment of the soft tissue structures within the subacromial space between the humeral head and the coracoacromial arch. A structural narrowing or decrease in the height of the subacromial space ensues with a consequent irritation and inflammation of the subacromial bursa. Swelling of the subacromial bursa may occur due to the inflammation process leading to further compression of the soft tissue structures and pain within the subacromial space. According to Neer (1983), this encroachment particularly takes place in the midrange of motion, often causing a painful arc during active abduction. Neer (1983) described three stages of SIS and estimated that 95 of rotator cuff tears result from SIS. Stage I is common in patients younger than 25 years and it is characterized by acute inflammation, edema and hemorrhage in the rotator cuff tendons. The clinical course is reversible with conservative treatment. Stage II is more common between the ages of 25 to 40 and represent a progression from acute edema and hemorrhage to fibrosis and tendinitis of the rotator cuff. It may not respond to conservative treatment. Stage III occurs in patients above 40 years. It is characterized by mechanical disruption of the rotator cuff tendons and changes in the coracoacromial arch. Primary impingement may occur in anyone who repeatedly or forcibly uses upper extremity in an elevated position although rotator cuff tears are more common in older populations (Jobe et al. 1983). Bigliani et al. (1997) concluded that acute subacromial bursitis due to trauma or overuse as in athletes may not completely resolve resulting into an impingement syndrome. Secondary impingements which often occur due to glenohumeral instability may also cause a decrease in the height of the subacromial space resulting to irritation and inflammation of the subacromial bursa and consequently an impingement syndrome (Witvrouw et al. 2008). In current literature, SIS is considered as a cluster of subacromial space lesions including subacromial bursitis, rotator cuff tendinitis, partial thickness rotator cuff and finally full thickness rotator cuff tears (Silva et al. 2008; Park et al. 2005). The diagnosis of SIS in clinical practice usually involves a subjective history, clinical examination tests and a confirmatory test. However, the diagnosis is a clinical challenge because the signs and symptoms associated with shoulder pathologies are similar and some patients may present with a combination of pathologies such as subacromial bursitis and rotator cuff tendinitis. Posterior, anterior and inferior capsular tightness is a common mechanical problem often associated with SIS especially in the individuals who avoid painful overhead activities due to pain (Corfield 1985; Flatow et al. 1994; Warner et al. 1990). The clinical tests used for the assessment of SIS are grouped into impingement tests and rotator cuff integrity tests. The integrity of the long head of the biceps tendon is also included in the clinical assessment of SIS. This is because the long head of the biceps tendon together with the rotator cuff muscles stabilizes the shoulder by depressing the humeral head into the capsule. Therefore lesions to the long head of the biceps may also result to impingement syndrome (Bigliani et al. 1997). The clinical tests used to diagnose SIS include the Hawkins-Kennedy impingement, Neer test and the cross body/ horizontal adduction test. The theory behind these tests is to isolate individual soft tissue structures and apply mechanical stress to test the tissue s integrity or compress them in order to provoke pain (Lewis 2009). Clinical tests such as include the Jobe test, Patte, test, drop arm test, external rotation lag sign test, lift-off tests etc. are being used to assess musculo-tendinous units of the rotator cuff. The specificity of some clinical tests was reported to be low in studies which affect the structural discriminating ability of the tests (Calis et al. 2000; MacDonald et al. 2000; Park et al. 2005; Silva et al. 2008). According to Lewis (2008), it is inconceivable how any test that is designed to assess the integrity and pain response from any of the rotator cuff tendons would not simultaneously either compress or stretch bursal 10

10 tissue and cause pain. Accordingly, this is potentially the major reason why clinical tests do not provide enough information to permit the identification of impingement syndrome as the cause of shoulder pain. The diagnostic accuracy of clinical tests is determined from the likelihood ratios (Davidson 2002). Diagnostic accuracy of these tests have been evaluated in studies using subacromial injection test, MRI, ultrasound and arthroscopy as the reference diagnostic standard (Calis et al. 2000; MacDonald et al. 2000; Park et al. (2006), Miller et al. (2007). MRI is considered an excellent noninvasive tool (Britaine et al. 2001) while arthroscopy is considered as the gold criterion standard (Miller et al. 2008). In studies encountered, conflicting ideas were reported on the diagnostic accuracy of clinical tests for SIS. The study of Calis et al. (2000) found the Hawkins-Kennedy test to be diagnostically accurate for the diagnosis of SIS. Whilst a metaanalysis by Hegedus et al. (2007) concluded that the diagnostic accuracy of the Hawkins-Kennedy test and Neer impingement test for SIS is limited but however concluded that either supraspinatus/ empty can test or infraspinatus tests may serve as a confirmatory test for impingement syndrome. Murrell et al. (2001) and Park et al. (2005) concluded that the clinical tests used for the diagnosis of SIS is age related and are more useful when the abnormality is severe. According to Murrel et al. (2001) if a patient is more than 60 years old and has weakness in external rotation and a positive impingement sign, the chance of a full thickness rotator cuff tear is 95. Whereas Park et al. (2005) found that if the patient is 60 years or older and has a weakness in external rotation, a positive painful arc and positive drop arm test, there is a greater than 90 chance of a rotator cuff tear and a 28 likelihood of a full thickness rotator cuff tear. This lack of consensus for the diagnosis of SIS presents an obstacle to the investigation of possible treatment interventions and prognosis. Various physiotherapy approaches have been suggested for the treatment of SIS including manual therapy and exercise therapy with the aim to decrease pain, improve strength, range of motion and consequently increasing function. Defects in proprioception and motor coordination of the rotator cuff and deltoid muscles have been reported to play a major role in the development of SIS, and physiotherapy is considered to be the first choice in conservative treatment toward improving balance of centering muscles and strengthening of the humeral head depressor muscles (Bigliani et al. 1997; Morrison et al. 1997). In studies, stretching and strengthening of the rotator cuff muscles and the capsule have been used in attempt to reduce symptoms, alter identified motion and muscle activity abnormalities (Bang et al. 2000; Ludewig et al. 2003). The duration of conservative treatment is considered to be a clinical decision based on the pathological stage of SIS however a period of six months seems to be justified from most trials (Bigliani et al. 1997; Dickens et al. 2005). The study of Bang et al. (2000) reported short term improvements in pain, strength and shoulder function when manual joint mobilizations techniques were combined with therapeutic exercises. Lombardi et al. (2008) demonstrated statistically significant improvements of the intervention group in function, pain at rest and pain during movement after a 2 month intervention period. However, the internal validity of some of the trials was questionable due to fact that some methodological aspects were missing. The purpose of this review was to determine the accuracy of clinical tests in the diagnosis of SIS and examine the effects of manual therapy and therapeutic exercises as treatment intervention methods in patients aged 16 an above? The hypothesis was that Firstly, clinical tests as assessment tools can accurately diagnose the presence of SIS and that a combined application of therapeutic exercises and Secondly manual therapy as treatment interventions will result in improvement of pain intensity, strength and functional loss in SIS patients. 11

11 METHODS AND MATERIALS Inclusion criteria The research question consisted of a diagnosis and treatment intervention component for SIS. Only articles written in English were used in writing this review. Inclusion criteria for studies that evaluated the diagnostic accuracy of clinical test were; Studies that used the clinical tests recommended for the diagnosis of rotator cuff pathology and SIS. Data on specificity and sensitivity, PPV, NPV and LR s should be provided in the study. In studies where the likelihood ratio is not calculated, sufficient data on specificity and sensitivity were provided to allow the calculation. The reference criterion and reference diagnostic standard of the clinical tests are stated. The results of the index clinical tests were compared to the findings of the reference standard used. Exercise and manual therapy intervention treatment studies were included if the; Studies were designed as a randomized controlled trial, clinical controlled trial or cohort studies. Outcome measures should include pain, strength, disability or functional loss. Participants should be more than 16 years old and demonstrate the clinical pattern of SIS (Bursitis, rotator cuff tendinitis, rotator cuff tears). Patient should manifest pain with overhead activities, display a positive painful arc sign, Neer impingement sign or positive Hawkins-Kennedy sign. Interventions used in the trials should include exercise and manual therapy (manipulation, massage, passive joint mobilization) only or in combination with other interventions or with no treatment. Other interventions typical to the field of physiotherapy may be included in the study but therapeutic exercise and or manual therapy supervised by a physiotherapist or home based exercises should be identified as the main treatment. In this review, therapeutic exercise is defined as the use of active or assisted exercises aimed at improving range of motion, strength, or dynamic neuromuscular control of the joint. Manual therapy is considered as the use of manually and or mechanically applied movement techniques to improve joint motion (Somty 2002). Exclusion Studies performed on cadavers and studies addressing general shoulder pain are not included. Studies were also rejected if the methodological quality was less than the minimum score set forth for this review and also if the initial diagnosis of the participants are not stated. (For intervention studies the minimum score was set at 6 points and for the diagnosis studies the minimum score for an article to be included was 6). Search and selection process Literature search related took place between the period of 4 th October 2010 and 14 th November The search was conducted for literatures published between 1980 and Articles were searched from EMBASE, MEDLINE, CINAHL, Cochrane, Pubmed, PEDro, Google Scholar, physical therapy journals, British Journal of Sports Medicine, statistical health websites, Science Direct, the HvA, UvA (AMC) and VU libraries. The following Mesh terms and key words were used alone or in combination: subacromial impingement syndrome, clinical tests, subacromial bursitis, primary shoulder impingement, shoulder pain, physical therapy, physiotherapy, pain, strength, rehabilitation, conservative treatment, shoulder, shoulder pain, glenohumeral joint, shoulder clinical assessment, physical therapy, exercise movement techniques, rotator cuff tendinitis, rotator cuff tears, randomized controlled trials, or clinical trial or controlled clinical trial. In addition to the search strategy outlined above, references of retrieved articles were reviewed in order to identify additional studies Data extraction and analysis Data from the studies were extracted independently by each reviewer and were later cross checked by switching over. Reviewer A retrieved data from the literature on intervention studies and reviewer B retrieved data from the literatures on diagnosis studies. Reviewer A later cross checked data from the diagnosis articles and reviewer B cross checked data from the intervention studies. Data on SIS and rotator cuff pathology were presented and analyzed separately. Data extracted from the studies evaluating the diagnostic accuracy of clinical tests included: sensitivity, specificity, PPV, NPV, LR+ and LRand the sample size. These informations were used to determine the diagnostic accuracy of the clinical tests. 12

12 Study selection Obtained from data base search 215 studies 125 studies were screened using abstract for inclusion and exclusion criteria Using our search strategy: Total studies obtained: Relevant studies retrieved for evaluation of full text articles. Full articles evaluating diagnosis of SIS included in the review. 11 Rotator cuff tears 6 Flowchart of screening process 16 rejected - included cervical spine pain and other shoulder pain. Full articles evaluating therapeutic exercise of SIS 5 SIS 5 Intervention 5 90 unrelated studies and duplicates were rejected 69 rejected after screening of title and abstract 24 Studies excluded after evaluation of full text: insufficient data Procedure in determining the diagnostic accuracy of clinical tests In this review, diagnostic accuracy will be determined based on the likelihood ratios of the individual test and the predictive values. Likelihood ratio is a very useful measure of diagnostic accuracy and it incorporates both the sensitivity and specificity value of a clinical test and provides a direct estimate of how much a test will change the odds of having a disease (Davidson 2002; Deeks and Altman 2004 and Jaeschke et al. 1994). Likelihood ratios are calculated as follows: LR + = sensitivity / (1- specificity) LR- = (1- sensitivity) / specificity. The higher the LR+ of the test is, the more indicative is the presence of a disease. A clinical test with a LR+ greater than 10 is considered to be diagnostically accurate. It is an indicator that a positive test will rule the disorder IN. A clinical test with a LR- of 0.1 or less is considered to be diagnostically accurate. It is an indicator that a negative test will rule the disorder OUT. LR+ between 5 to10 and LR- between 0.1 to 0.2 will provide diagnostic evidence and help in screening for the pathology (Davidson 2002; Deeks and Altman 2004; Jaeschke et al. 1994; Dinnes et al. 2003). Since LR s are calculated from both specificity and sensitivity, it does not depend on the disease prevalence in examined groups. Consequently, the likelihood ratios from one study are applicable to some other clinical setting, as long as the definition of the disease is not changed. The PPV and NPV values of clinical tests are important diagnostic criteria in considering the presence of absence of a lesion. Predictive values are largely dependent on disease prevalence in examined population. Therefore, predictive values from one study should not be transferred to some other setting with a different prevalence of the disease in the population. Prevalence affects PPV and NPV differently. PPV is increasing, while NPV decreases with the increase of the prevalence of the disease in a population. Data extracted from the exercise and manual therapy intervention treatment studies for SIS included study design, sample size, mean age of participants, interventions and frequency, p values, the outcome measures and outcomes of pain, strength and function of each trial. Outcomes for pain at rest, pain on movement and 24 hour pain were measured using the VAS scale. Patient satisfaction and functional outcome questionnaires were used to measure functional improvements. Strength was measured using a Dynamometer. The effectiveness of the treatment interventions was evaluated using the qualitative analysis of the levels of evidence as defined by Tulder et al. (2003) as described in table 1. Table 1: Levels of evidence (Tulder et al. 2003) Strong Consistent findings among multiple high quality RCTs Moderate Consistent findings among multiple low quality RCTs, CCT and or one high quality RCT Limited One low quality RCT and or CCT Conflicting Inconsistent findings among multiple trials (RCTs and or CCTs) No evidence No RCTs or CCTs 13

13 Methodological Quality assessment Criteria list Two independent criteria lists were used in the grading of the articles. A detailed description of both criteria lists is provided in appendix 1 and 2. To judge the validity and reliability of both criteria lists, a pilot study was performed on two trials. The trial of Bang et al. (2000) was independently graded by both reviewers, the scores allocated were compared and was found to differ by 2 points. Similarly, the diagnostic study of Calis et al. (2000) was also graded and the point score difference was 1. Based on these results, the criteria lists were considered to be reliable. The methodological quality of the diagnostic studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies QUADAS tool (Whiting et al. 2004). The QUADAS tool contains 14 components and each of the 14 questions were scored yes, no or unclear. One point was allocated to each YES. A score of 7 of 14 yeses is indicative of a good quality study (study is included) and scores below 7 are indicative of low quality (study is rejected). The studies on the treatment interventions were graded using the PEDro scale. The scale contains 8 criteria for assessing internal validity of a study and 2 criteria for assessing sufficiency of the statistical information. The possible maximum score is 10 points. Each criterion is answered YES (1 point) or NO (0 point). If a criterion is unclear even after discussion, no point was awarded. A study by Maher et al found the scale reliable for rating the quality of randomized controlled trials. A study is considered to be of high quality if the PEDro score is greater than five and of low quality if the PEDro score is five or less (Maher et al. 2003). To ensure that we use high quality articles and improve the validity of the results, only studies that scored a six and above were included in this review. Article points score classification were as follows: 6-7 (Good); 7-9 points (Very good), 9-10 (excellent). RESULTS Search results The search strategy from the databases resulted to 215 studies. 90 duplicate studies and unrelated studies were removed 125 studies were left. 69 studies were rejected during the initial screening of title and abstract. From the 56 studies left, 16 were excluded because they included patients with disorders of the cervical spine and other shoulder pathologies other than impingement syndrome. 40 full text copies of studies were obtained. 24 full text studies were further rejected because the methodological quality was low, they lacked specific description of interventions used, diagnostic criteria and reference standards were not clearly explained. A final yield of 16 full text studies was obtained. 11 studies examined the accuracy of clinical tests for the diagnosis of SIS and rotator cuff integrity. 5 studies evaluated the effect of manual and exercise therapies as treatment interventions for SIS. Quality of studies Quality of studies that evaluated the accuracy of clinical tests; Table 2 contains the list of the studies on clinical test evaluation used in this review. The mean methodological score of all the studies was 10 out of 14 (range 7-13 points). The sample size of the participants ranged from 30 to 552 with age ranging from 13 to 80 years and the mean age ranged from 40 to 56 years. The study Silva et al. (2008) had the smallest sample size of 30 and Itoi et al included the youngest participant of age 13 years. A total of 21 clinical tests were evaluated either individually or in combination across all 11 studies. Six clinical tests were examined in more than three studies: Hawkins-Kennedy test, Neer test, painful arc, Drop arm sign, lift-off test and Empty can test. In three studies measurements of the index clinical test were blinded from the diagnostic reference standard investigators (Ardic et al. 2006, Holtby et al. 2004; Miller et al. 2007). Four studies (Ardic et al. 2006; MacDonald et al. 2000; Park et al and Silva et al. 2008) evaluated the utility of combinations of clinical tests as diagnostic tools for SIS. Holtby et al is the only study that assessed one clinical test by evaluating the value of empty can test in detecting partial thickness, full thickness and massive full thickness tears of the supraspinatus tendon. 14

14 Table 2: Selected studies on clinical tests evaluation and diagnosis of SIS. Study Ardic et al. (2005) Calis et al. (2000) QUADAS score Clinical examination tests Sample size Reference standard 12 -Hawkins-Kennedy N = 58 patients MRI -Neer (impingement) 59 shoulders -Speeds test Mean age = 55 Range : not stated 8 -Hawkins-Kennedy N = 120 Subacromial -Neer (impingement) 125 shoulders injection test or -Drop arm Mean age = 52 MRI -Horizontal adduction Range : ful arc -Speed -Yergason MacDonald et al. (2000) Park et al. (2005) Silva et al. (2008) Barth et al. (2006) Hertel et al. (1996) Holtby et al. (2004) Miller et al. (2008) 8 -Hawkins Kennedy -Neer test 10 -Horizontal adduction -Drop arm sign -Hawkins-Kennedy -Neer impingement -External rotation strength test (Infraspinatus) -ful arc -Empty can test -Speed test 12 - Passive abduction -Neer test -Hawkins-kennedy -Yocum manoeuvre -Jobe manoeuvre/ Empty can test -Patte manoeuvre -Gerber / lift off test -Resisted abduction 11 -Bear-hug sign -Belly press sign -Napoleon -Lift-off test 7 -Drop sign -Internal rotation lag sign -External rotation lag sig N = 85 Mean age = 40 Range : Mean age :not stated Range : not stated N= 30 Mean age: 55 years Range : not stated N = 68 Mean age: 45 years Range : N= Mean age = 51 Range : Lift off sign 13 -Empty can test N = 50 Mean age = 50 Range: External rotation lag sign -Drop sign -Internal rotation lag sign N = 37 Mean age : 56 years Range: Arthroscopy Arthroscopy MRI Arthroscopy Arthroscopy Arthroscopy Ultrasound Itoi et al. (1999) Itoi et al. (2006) 8 -Full can test -Empty can test 11 - Lift -off -Full can test -Empty can test -External rotation strength test N = 136 Mean age = 43 Range: N = 149 Mean age = 53 Range : years MRI Arthroscopy 15

15 Quality of studies on exercise and manual therapy intervention. The mean methodology quality of exercise and manual therapy interventions articles was 6 (range 6-8). 332 participants were included in all the studies and the sample size was in the range of 33 to 92. There were 193 males and 126 females included in all the 5 intervention studies. The study of Kachingwe et al. (2008) had the smallest sample size of 33 participants and Ludewig et al. (2003) had the largest sample size of 92. The age range of the participants was between 16 to 74 years and the mean age range of 43 to 56 years. Participant follow-up in the studies ranged from 86 to. The study of Dickens et al. (2005) had the lowest follow-up rate of 86 and the longest patient follow-up period of 12 months. Two trials used exercise therapy interventions only Lombardi et al. (2008) and Ludewig et al. (2003) compared to a control group that received no intervention. The studies Bang et al. (2000) and Kachingwe et al. (2008) compared an exercise intervention only group to a group receiving both exercise therapy and manual therapy interventions while Dickens et al (2005) used both exercise and manual therapy interventions compared to a control group of patients that were awaiting surgery. To determine the effect of the interventions, pain, strength, patient satisfaction and functional loss or disability were used as the outcome measure. The measurement instruments used for each variable are described in table 12. Table 3: Selected articles reporting on the treatment interventions for SIS. Study + design Bang et al. (2000) RCT Dickens et al., (2005) PR study Kachingwe et al. (2008) RCT pilot Lombardi et al. (2008) RCT Ludewig et al. (2003) RCT PEDro Method of score diagnosis 6 Clinical test, positive impingement test. 8 History + Neer test, + steroid injections 8 Positive Neer and Hawkins- Kennedy impingement test. 8 Positive Neer + Hawkins test. 6 At least 2 positive impingement tests. Diagnosis Impingement syndrome Impingement impingement Impingement Impingement + biceps tendonitis Outcome of interest - (VAS) -Strength -Function (FAQ) - -Function -24 hour pain - with Neer &Hawkins test -Shoulder function: SPARDI - at rest (VAS) - during movement (VAS) -Function / disability - Patient satisfaction Likert scale -Function (SQR) - -Disability -Satisfaction Drop Follow Followup out up period 2 2 months months and 12 months weeks 4 2 months weeks 92 16

16 RESULTS Diagnostic accuracy of clinical tests for subacromial impingement syndrome. In the 11 diagnostic studies reviewed, a total of 102 evaluations of 21 clinical tests were performed either singularly or in combination in order to determine their clinical diagnostic accuracy in detecting SIS / a tear of the rotator cuff tendon. 12 individual clinical tests evaluations and 5 test combinations (17) showed diagnostic accuracy in detecting a lesion of the rotator cuff tendon with either a LR+ 10 or a LR- <0.1. Impingement tests The data of performance characteristics of impingement tests are represented in table 5. Hawkins-Kennedy test showed clinical accuracy with a LR and NPV for Zlatkin 3 tear using pain as the response criteria (Calis et al.). Yocum test was found to be clinically accurate with a LR , sensitivity 79 but the NPV was moderate 50 (Silva et al. 2008). Neer test was inaccurate in eight evaluations across four studies but Park et al reported a PPV of 80 for an impingement of any severity and a NPV of 93 for PTT. This makes the Neer test valuable for the screening of SIS because with a high PPV value, a positive test will indicate the presence of an impingement to a certain degree. Likewise with a high NPV a negative test will be indicative of the absence of an impingement. The horizontal abduction test was inaccurate in six evaluations. However Park et al reported a specificity of 82 and PPV of 69 for an impingement of any severity. Whereas Calis et al. reported a sensitivity of 83 and 90 for Zlatkin 2 and 3 respectively. Table 4: Performance characteristics of clinical tests for subacromial impingement. Clinical test and study Hawkins-Kennedy Calis et al. (2000) MacDonald et al. (2000) Park et al. (2005) Silva et al. (2008) Response criterion Degree of tear Zlatkin 1 Zlatkin 2 Zlatkin 3 Any severity PTT Sen Spec PPV NPV LR LR Cross - body adduction Calis et al. (2000) Park et al. (2005) Neer test Calis et al. (2000) MacDonald et al. (2000) Park et al. (2005) Silva et al. (2008) Zlatkin 1 Zlatkin 2 Zlatkin 3 Any severity PTT Zlatkin 1 Zlatkin 2 Zlatkin 3 Any severity PTT Yocum test Silva et al. (2008)

17 Zlatkin stage 0: Tendon morphology and signal intensity are normal. Zlatkin stage 1: Increased signal intensity in the tendon without irregularity and thinning in the tendon. Zlatkin stage 2: Increased intensity with irregularity and thinning in the tendon. Zlatkin stage 3: Complete disruption of supraspinatus tendon, Sen: sensitivity, Spec: specificity, PTT: partial thickness tear, : Full thickness tears, : Not stated. Combination tests for SIS. Data of performance characteristics of combination tests are presented in Table 5. Four combinations tests were evaluated twelve times across four studies (Table 4). Three combination tests were found to have clinical diagnostic accuracy in the study of Park et al. (2005). Firstly, if all three tests Hawkins-Kennedy, painful arc and infraspinatus muscle test are positive the LR+ was indicating that the combination is clinically accurate in the diagnosis of overall impingement. The PPV was 95. The possibility that a patient who tested positive on all three tests would have impingement syndrome to some degree was more than 95 (Park et al. 2005). A LR+ of 5 is demonstrated if two of the three tests are positive making the combination valuable as a screening tool for overall impingement. Secondly, a positive drop arm test, painful arc and weakness in infraspinatus muscle test revealed a LR+ of and a PPV of 91 making the combination clinically accurate in the detection of a full thickness tear of the infraspinatus tendon. Thirdly, if the patient is more than 60 years old and all three tests drop arm, painful arc and weakness in infraspinatus muscle test are positive, the LR+ was and the PPV was 95 demonstrating clinical accuracy in detecting a full thickness rotator cuff tendon tear in this age category. Table 5: Performance characteristics of combination tests for subacromial impingement syndrome Clinical test and study Hawkins-Kennedy or Neer MacDonald et al. (2000) Ardic et al. (2006) Hawkins Kennedy and Neer MacDonald et al. (2000) Silva et al. (2008) Drop arm + painful arc + infraspinatus muscle test Park et al. (2005) Drop arm + painful arc + infraspinatus muscle test Park et al. (2005) Hawkins-Kennedy+ painful arc sign + infraspinatus muscle test Park et al. (2005) Response criterion pain Degree of tear if All 3 tests + ve 2 of 3 tests + ve 1 of 3 tests + ve -All 3 test +ve patient 60 years or older -All 3 tests +, patient < 60 years Overall impingement All 3 tests +ve 2 of 3 tests +ve 1 of 3 tests +ve Sen Spec PPV NPV LR+ LR Sen: sensitivity, Spec: Specificity, PTT: Partial thickness tears, : Full thickness tears, : Not stated, PPV: Positive predictive value, NPV: Negative predictive value, LR+: Positive likelihood ratio, LR-: Negative likelihood ratio. 18

18 Diagnostic accuracy of clinical tests evaluating the integrity of rotator cuff tendons. Supraspinatus test. The performance characteristics and values of supraspinatus tests are represented in table 6. ful arc test was evaluated in two studies comparatively to SIT/MRI (Calis et al. 2000) and arthroscopy (Park et al. 2005) but did not demonstrate diagnostic accuracy in six evaluations. Sensitivity values were conflicting in both studies. Specificity in contrast was high. However, Park et al reported high NPV values of 91 and 76 for PTT and respectively. For the detection of a tear of any severity, PPV of 88 was reported indicating a positive test would mean there is an 88 chance that a supraspinatus tendon tear is present (Park et al. 2005). The empty can/ Jobe test/ supraspinatus muscle test was found to lack clinical accuracy in twelve evaluations performed across five studies. NPV varied across the studies. Itoi et al. (1999) used muscle weakness as the response criteria for reported NPV of 90. The highest NPV of 93 was obtained when both muscle weakness or pain or both was used as the response criteria. Similarly, Park et al. (2005) reported an NPV of 88 using muscle weakness as the response criteria for PTT. In these two studies, a negative Jobe test correlated with tendon tearing. Full can test failed to show clinical accuracy in five evaluations across two studies (Itoi et al. 1999; Itoi et al. 2006). The test proved useful with a sensitivity of 86 and NPV of 93 when pain or muscle weakness was used as response criteria (Itoi et al. 1999). Drop arm test was evaluated eight times across four studies and three test evaluations in two studies were found to be clinically accurate. Calis et al. (2000) reported a LR+ of (infinity) for Zlatkin stage 1 (PPV, specificity ) and Zlatkin stage 3 (PPV, specificity ). Hertel et al. (1996) reported a LR+ of 26.1 (PPV and a specificity of 98). In all four studies that evaluated the drop arm test, the specificity was in the range 77 to indicating that a positive test will strongly rule in a tear of the supraspinatus tendon. Subacapularis test. Data of performance characteristics and values of clinical tests evaluations are represented in table 7. Five subacapularis tests (Bear-hug, Belly-press, Lift-off, Napoleon and Internal rotation lag sign) were evaluated in four studies. Bear-Hug test did show a specificity of 92, PPV 75 and NPV 85. With a LR+7 diagnostic accuracy was not demonstrated but a positive test result will be useful as a screening tool. Lift-off test was found to be diagnostically accurate in two studies. Barth et al. (2000) using muscle weakness as the response criteria reported a LR+ of and Hertel et al. (1996) using a lag or drop of the arm as the response criteria reported a LR+ of 31. Both studies reported a specificity of and PPV of. Internal rotation lag sign is the only test that demonstrated clinical accuracy with both a LR+ 23 and a LR in the study of Hertel et al. (1996) with a corresponding PPV of 97 and NPV 96. Contrary to Hertel et al., Miller et al. (2008) reported a LR- of 0.00 also demonstrating clinical accuracy and an NPV of. Napoleon test was found to be diagnostically accurate with a LR+ of (PPV 83 and specificity 98) in detecting a PTT when muscle weakness was used as the response criterion. The Belly-press also demonstrated accuracy with a LR+ of 19.05, specificity 98 and PPV 89 (Barth et al. 2006). Among the entire subscapularis test, the lift-off test demonstrated the highest specificity of and PPV in two different studies (Barth et al. 2006; Hertel et al. 1996). 19

19 Table 6: Performance characteristics of supraspinatus tests Clinical test and study Response criterion Degree of tear Sensitivity Specificity PPV NPV LR+ LR- ful arc Calis et al. (2000) Park et al. (2005) Empty can / Jobe test Holtby et al. (2004) Itoi et al. (1999) Itoi et al. (2006) Park et al. (2005) Silva et al. (2008) + muscle weakness + muscle weakness + muscle weakness Muscle weakness Either or Both Muscle weakness < grade 5 Muscle weakness Muscle weakness Muscle weakness Zlatkin1 Zlatkin 2 Zlatkin 3 Any severity PTT PTT Massive Any severity PTT Not Stated Drop arm / sign Calis et al. (2000) Hertel et al. (1996) Park et al. (2005) Miller et al. (2008) (infraspinatus & supraspinatus) + muscle weakness NR + arm drop Not Stated Zlatkin 1 Zlatkin 2 Zlatkin 3 Any severity PTT Full can test Itoi et al. (1999) Muscle weakness Either or both Itoi et al. (2006) Muscle weakness < grade

20 Information for table 6: Supraspinatus test. Zlatkin stage 0: Tendon morphology and signal intensity are normal. Zlatkin stage 1: Increased signal intensity in the tendon without irregularity and thinning in the tendon, Zlatkin stage 2: Increased intensity with irregularity and thinning in the tendon, Zlatkin stage 3: Complete disruption of supraspinatus tendon. PTT: partial thickness tear, : Full thickness tear, : Not stated Table 7 Performance characteristics of clinical tests for detecting a tear of the Subscapularis tendon. Clinical test and study Response criterion Degree of tear Sen Spec PPV NPV LR+ LR- Bear-hug test Barth et al. (2006) Muscle weakness Belly press test Barth et al. (2006) Muscle weakness Lift off test Barth et al. (2006) Itoi et al. (2006) Muscle weakness Muscle weakness Lag or drop Hertel et al. (1996) Napoleon test Barth et al. (2006) Muscle weakness PTT Internal rotation lag sign Hertel et al. (1996) Miller et al. (2008) Weakness Sen: sensitivity, Spec: Specificity, Infraspinatus test Data of performance characteristic and values of clinical tests evaluation are presented in Table 8. Four clinical tests were evaluated across five studies. External rotation lag sign test demonstrated high specificity and PPV percentages of when weakness in active external rotation was used as the diagnostic criterion. A LR+ of 35 was found proving clinical accuracy in detecting tears of the infraspinatus tendon (Hertel et al. 1996). Miller et al. (2008) demonstrated a LR+ of 8 in detecting a full thickness tear and a PPV of 77 (specificity 94) in detecting a but clinical accuracy was not demonstrated in this study with a LR+ of 8. External rotation strength test was inaccurate in five evaluations. Although the test did not show diagnostic accuracy, Park et al reported a PPV of 91 and a specificity of 90 using pain and weakness as the response criterion in detecting an infraspinatus tendon tear of any severity. These high values make the test clinically important in screening for a tear of the supraspinatus tendon. Test for the long head of the biceps tendon Data of performance characteristics and values of clinical evaluation tests are presented in table 9. Speed test lacked clinical accuracy in seven evaluations across three studies due to the low LR demonstrated. In detecting a biceps tendon tear of any severity, Park et al. (2005) reported a specificity of 83 and PPV 81 making the test valuable in screening for tears. Yergason test was evaluated only by Calis et al. (2000) and was inaccurate in three evaluations. Specificities of 88, 85 and 86 were reported for detecting a Zlatkin 1, 2 and 3 tear respectively using pain as the diagnostic criterion. The high specificity makes the test valuable in ruling in a tear of the biceps tendon in clinical practice if the test is positive (SpIN). A PPV of 84 and 83 was also reported for Zlatkin stage 2 and 3 tears. 21

21 Table 8 Performance characteristics of clinical tests for detecting a tear of the infraspinatus tendon. Clinical test and study ERST (infraspinatus test) Park et al. (2005) Itoi et al. (2006) ERLS Hertel et al. (1996) Miller et al. (2008) Response criterion, weakness Muscle weakness < 5 Weakness in active ER Degree of tear Any severity PTT Tears Sen Spe PPV NPV LR LR Patte s test Silva et al. (2008) ERST: External rotation strength test, ERLS; External rotation lag sign assesses supraspinatus and infraspinatus full thickness tears, Sen: Sensitivity Spec: Specificity. Table 9 Performance characteristics of tests for detecting a tear of the long head of the biceps tendon. Clinical test and study Speed test Park et al. (2005) Ardic et al. (2006) Calis et al. (2000) Response criterion Degree of tear Any severity PTT Zlatkin 1 Zlatkin 2 Zlatkin 3 Sen Spec PPV NPV LR LR Yergason Calis et al. (2000) Zlatkin 1 Zlatkin 2 Zlatkin Tests for subacromial bursitis Data of performance characteristics and values of clinical evaluation tests are presented in table 10. Six clinical tests; Neer sign, Hawkins-Kennedy, horizontal adduction test, infraspinatus muscle test, Patte test and the Gerber s lift-off test were evaluated in three studies (MacDonald et al. 2000, Park et al and Silva et al. 2008). Gerber s lift-off test was the most sensitive 93, NPV 91 and showed diagnostic accuracy with a LR (Silva et al. 2008). The Hawkins-Kennedy and the Neer sign showed high sensitivity values (range 76 to 92) across all 3 studies but the specificity was low in the range of 43 to 49 (Macdonald et al. 2000; Silva et al. 2008; Park et al. 2005). The Hawkins-Kennedy and Neer tests due to the high sensitivity demonstrated maybe useful during clinical examination in ruling out the presence of subacromial bursitis if the tests are negative. The NPV was in the range of 68 to 96 in all three studies. Cross body adduction test proved to be the most specific test with a specificity of 79 when pain is used as the response criteria (Park et al. 2005). Clinical accuracy was lacking because of the low LR. 22

22 Combination tests for subacromial bursitis. Performance characteristic and values of clinical evaluation tests are presented in Table 11. A combination of Patte s and Gerber s test proved to be diagnostically accurate with a LR+ of 10.3 and a PPV of 92 when pain is use as the response criteria (Silva et al. 2008). By using either Neer or Hawkins-Kennedy test also shows diagnostic accuracy with a LR- of (MacDonald et al. 2000). A combination of Neer and Hawkins-Kennedy test was found to lack clinical accuracy (MacDonald et al. 2000). The specificity and PVV for the two combination tests were low. For all the combination tests, the most sensitive test was a combination of Hawkins or Neer (96), Patte and Gerber (73) and Hawkins-Kennedy and Neer test (71) consecutively. Table 10: Performance characteristics of clinical tests for detecting subacromial Bursitis Clinical test and study Response criteria Sensitivity Specificity PPV NPV LR + LR- Neer sign MacDonald et al. (2000) Silva et al. (2008) Park et al. (2005) Hawkins-Kennedy MacDonald et al. (2000) Silva et al. (2008) Park et al. (2005) Cross body adduction Park et al. (2005) Infraspinatus muscle test Park et al. (2005) Patte test Silva et al. (2008) Gerber s lift-off test Silva et al. (2008) Sen: Sensitivity Spec: Specificity Table 11 Performance characteristics of combination of tests for subacromial bursitis Clinical test and study Response Sensitivity Specificity PPV NPV LR + LR - criteria Hawkins or Neer MacDonald et al (2000) Hawkins & Neer MacDonald et al (2000) Patte & Gerber Silva et al (2008) NA NA: Not applicable 23