Diagnostic classification of shoulder disorders: interobserver agreement and determinants of disagreement

OBJECTIVES: To assess the interobserver agreement on the diagnostic classification of shoulder disorders, based on history taking and physical examination, and to identify the determinants of diagnostic disagreement. METHODS: Consecutive eligible patients with shoulder pain were recruited in various health care settings in the Netherlands. After history taking, two physiotherapists independently performed a physical examination and subsequently the shoulder complaints were classified into one of six diagnostic categories: capsular syndrome (for example, capsulitis, arthritis), acute bursitis, acromioclavicular syndrome, subacromial syndrome (for example, tendinitis, chronic bursitis), rest group (for example, unclear clinical picture, extrinsic causes) and mixed clinical picture. To quantify the interobserver agreement Cohen's kappa was calculated. Multivariate logistic regression analysis was applied to determine which clinical characteristics were determinants of diagnostic disagreement. RESULTS: The study population consisted of 201 patients with varying severity and duration of complaints. The kappa for the classification of shoulder disorders was 0.45 (95% confidence intervals (CI) 0.37, 0.54). Diagnostic disagreement was associated with bilateral involvement (odds ratio (OR) 1.9; 95% CI 1.0, 3.7), chronic complaints (OR 2.0; 95% CI 1.1, 3.7), and severe pain (OR 2.7; 95% CI 1.3, 5.3). CONCLUSIONS: Only moderate agreement was found on the classification of shoulder disorders, which implies that differentiation between the various categories of shoulder disorders is complicated. Especially patients with high pain severity, chronic complaints and bilateral involvement represent a diagnostic challenge for clinicians. As diagnostic classification is a guide for treatment decisions, unsatisfactory reproducibility might affect treatment outcome. To improve the reproducibility, more insight into the reproducibility of clinical findings and the value of additional diagnostic procedures is needed.     

Incidence and prevalence of complaints of the neck and upper extremity in general practice

OBJECTIVE: To study the incidence and prevalence of neck and upper extremity musculoskeletal complaints in Dutch general practice. METHODS: Data were obtained from the second Dutch national survey of general practice. In all, 195 general practitioners (GPs) from 104 practices across the Netherlands recorded all contacts with patients during 12 consecutive months. Incidence densities and consultation rates were calculated. RESULTS: The total number of contacts during the registration period of one year was 1 524 470. The most commonly reported complaint was neck symptoms (incidence 23.1 per 1000 person-years), followed by shoulder symptoms (incidence 19.0 per 1000 person-years). Sixty six GP consultations per 1000 person-years were attributable to a new complaint or new episode of complaint of the neck or upper extremity (incidence density). In all, the GPs were consulted 147 times per 1000 registered persons for complaints of the neck or upper extremity. For most complaints the incidence densities and consultation rates were higher for women than for men. CONCLUSIONS: Neck and upper extremity symptoms are common in Dutch general practice. The GP is consulted approximately seven times each week for a complaint relating to the neck or upper extremity; of these, three are new complaints or new episodes. Attention should be paid to training GPs to deal with neck and upper limb complaints, and to research on the prognosis and treatment of these common complaints in primary care.     

Prevalence of tendinitis and related disorders of the upper extremity in a manufacturing workforce

A cross sectional survey of a randomly selected population of 2,261 textile workers form an overall population of 8,539 eligible workers was performed to evaluate the prevalence of tendinitis in related upper extremity disorders. Of the sample, 2,047 respondents (91.3%) participated in a nurse screening history and examination: 1,091 (53%) had no upper extremity symptoms or abnormalities on examination; 959 (47%) with positive findings were examined by trained physicians. Of these, 347 (36.5%) were found to have no abnormality, whereas, 548 (57.3%) workers were assigned a diagnosis. Of these 227 were considered to fall into the categories of tendinitis (n = 69) or related disorders (n = 158). The projected prevalence of tendinitis and related disorders for the overall group was 11.6% (carpal tunnel syndrome 1.1%, epicondylitis 2.0%, tendinitis 3.5%, shoulder condition 2.3%, ganglion 2.3%, neck conditions 4.0%). Tendinitis was less frequent in the older age group and those employed for a longer time. The prevalence of tendinitis was found to be statistically higher in physically demanding job categories. Ninety-four percent of ailments were of mild or moderate severity. Although our study provides prevalence data for these conditions in a large manufacturing workforce across several job categories.     

Prognostic indicators for non-recovery of non-traumatic complaints at arm, neck and shoulder in general practice--6 months follow-up

OBJECTIVES: To identify predictors of non-recovery in non-traumatic complaints at the arm, neck and shoulder in general practice 6 months after the first consultation. METHODS: A prospective cohort study was set in 21 Dutch general practices. Consulters with a first or new episode of non-traumatic arm, neck or shoulder complaints and age 18 through 64 yrs entered the cohort. Complaint, patient, physical, psychosocial and work characteristics were investigated as possible predictors of non-recovery at 6 months using multiple logistic regression analyses (backward Wald). RESULTS: At 6 months, 46% of the total population (n = 612) and 42% of the working subpopulation (n = 473) still reported complaints. Complaint characteristics (long duration of the complaint before consultation, recurrent complaint, musculoskeletal comorbidity and complaint mainly located at wrist or hand) were most predictive of non-recovery followed by psychosocial characteristics (more somatization and experiencing less social support). Having a specific diagnosis was associated with recovery. In the working subpopulation, the same variables were predictors of non-recovery. Additionally, low supervisory support was associated with non-recovery. The models correctly classified 72-75% of the patients (explained variance 0.27-0.28). CONCLUSIONS: Besides questions on complaint characteristics, information on somatization and support can help a general practitioner to recognize patients at risk of persistent complaints.     

The incidences of and consultation rate for lower extremity complaints in general practice

OBJECTIVE: To estimate the incidence and consultation rate of lower extremity complaints in general practice. METHODS: Data were obtained from the Second Dutch National Survey of General Practice, in which 195 general practitioners (GPs) in 104 practices recorded all contacts with patients during 12 consecutive months in computerised patient records. GPs classified the symptoms and diagnosis for each patient at each consultation according to the International Classification of Primary Care (ICPC). Incidence densities and consultation rates for different complaints were calculated. RESULTS: During the registration period 63.2 GP consultations per 1000 person-years were attributable to a new complaint of the lower extremities. Highest incidence densities were seen for knee complaints: 21.4 per 1000 person-years for women and 22.8 per 1000 person-years for men. The incidence of most lower extremity complaints was higher for women than for men and higher in older age. CONCLUSIONS: Both incidences of and consultation rates for lower extremity complaints are substantial in general practice. This implies a considerable impact on the workload of the GP.     

Dyspepsia management in primary care in The Netherlands: to what extent is Helicobacter pylori diagnosis and treatment incorporated? Results from a survey among general practitioners in The Netherlands

BACKGROUND: Many guidelines on the management of Helicobacter pylori (HP)-related dyspepsia have been launched over the past decade. The suggested policies in these guidelines are often more consensus- than evidence-based (test-and-treat policy, test and endoscope), which may cause confusion among primary-care physicians. AIM: To determine the current management of HP-related dyspepsia by Dutch general practitioners (GPs). METHODS: A random sample of 5% of all Dutch GPs (n = 355) were sent a questionnaire on the diagnosis and treatment of HP infections in dyspepsia management. RESULTS: The response rate was 66.2% (n = 235). Almost 80% of the responding GPs stated they had conducted HP testing (via endoscopy or serology) during the previous 12 months. In the same time period, more than 94% had actually prescribed a HP eradication therapy. A total of 70% of the GPs stated that they used endoscopy to test for HP infection, 54% used serology (ELISA); whole-blood tests and carbon urea breath tests were not used. Patients with a history of peptic ulcer disease, those on chronic acid-suppressive drugs and patients with recurrent ulcer-like complaints were most frequently tested for HP infection. CONCLUSIONS: Given the frequency of consultations for dyspepsia in primary care in the Netherlands (150 new dyspeptic patients per average practice per year), and the reported average number of HP tests performed (1-5 per GP per year), HP diagnosis plays a modest role in the management of dyspepsia in Dutch general practices. Neither the 'test-and-treat' policy recommended in the Maastricht guidelines, nor its advice regarding the choice of diagnostic tests (carbon urea breath test or serology), is being followed. The majority of GPs uses endoscopy for the detection of HP infection.     

Irritable bowel syndrome in general practice: an overview

BACKGROUND: Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder that is frequently seen in gastroenterological practice. Population-based studies have shown that at any point in time IBS symptoms are present in about 3%-22% of the general Western population. In general practice, half of all new patients have functional disorders and IBS is responsible for about five consultations per week. General practitioners (GPs) manage the majority of IBS patients, but most knowledge (and research) is based on the smaller percentage of patients managed in secondary care. There is a paucity of literature on differences or similarities between these two groups with regard to clinical characteristics or diagnostic approach. METHODS: The literature published in English about IBS in general practice was reviewed. CONCLUSIONS: Irritable bowel syndrome is frequently encountered in primary care. Primary care IBS patients, compared to secondary care patients, are likely to be young, female and to have less severe symptoms. But this is only true for some symptoms; for example, non-abdominal complaints are equally reported in both groups. The disorder can be diagnosed safely using internationally agreed symptom-based criteria, such as the Rome II criteria. Additional diagnostic measures will be necessary to support the diagnosis in only a minority of situations. Many primary care IBS patients can be managed given adequate reassurance and education, frequently without additional pharmacological treatment.     

Hand dominance in upper extremity musculoskeletal disorders

OBJECTIVE: To investigate the role of hand dominance in common upper extremity musculoskeletal disorders (UEMSD) in a population study. METHODS: The target population consisted of a representative sample of people aged 30 years or older residing in Finland during 2000-2001. Of the 7977 eligible subjects, 6254 (78.4%) were included in the study. RESULTS: The prevalence of UEMSD was as follows: rotator cuff tendinitis 3.8%, bicipital tendinitis 0.5%, lateral epicondylitis 1.1%, medial epicondylitis 0.3%, carpal tunnel syndrome (CTS) 3.8%, and surgery due to CTS 1.3%. CTS was 2.5 times as prevalent in women as men, whereas the other UEMSD were as common in both sexes. Rotator cuff and bicipital tendinitis and medial epicondylitis were more prevalent in the dominant arm only in women, whereas lateral epicondylitis was more prevalent in the dominant elbow in both sexes. The higher prevalence of rotator cuff and bicipital tendinitis in the dominant side persisted beyond working age. The prevalence of CTS did not differ by hand dominance. Dominant hand had been operated more frequently for CTS in women. CONCLUSION: Our findings show that UEMSD are more prevalent in the dominant than nondominant arm mainly in women. For shoulder tendinitis, the difference persists throughout adult age. Physical load factors may have long-lasting effects on the shoulder and they may play a greater role in women than men.     

One-year prognosis of primary care dyspepsia: predictive value of symptom pattern, Helicobacter pylori and GP management.

BACKGROUND AND AIMS : Dyspepsia is a highly prevalent, heterogeneous condition with a poorly defined clinical course in family practice. We observed its clinical outcome and identified prognostic factors. PATIENTS : We studied 583 patients presenting to their general practitioner (GP) with a new episode of dyspeptic complaints. METHODS : A validated dyspepsia severity score was used to observe deterioration of dyspepsia. Furthermore, the general health status and the patient's perception of no improvement were registered. As prognostic determinants, demographic characteristics, concomitant conditions, and management were studied. Univariate and multivariate analyses were performed. RESULTS : A total of 518 (89%) patients completed the 1-year follow-up. Of these, 111 patients (22%, 95% CI 18% to 25%) had a negative change in their dyspepsia score after 1 year; 46 patients (9%, 95% CI 6% to 11%) noted impairment of general health; and 122 patients (24%, 95% CI 20% to 28%) regarded complaints as not improved. Frequent dyspepsia (>1 episode/year) and a history of peptic ulcer predicted deterioration of dyspepsia, while smoking and little psychological distress predicted impairment of general health. Eradication of Helicobacter pylori reduced the chance of patient's negative judgement for especially those with frequent dyspepsia. CONCLUSION : One-quarter of the dyspepsia patients had an unfavourable 1-year prognosis, which was predictable because of frequent complaints and previously diagnosed ulcers. Psychological factors need to be identified, since they are related to general health improvement. The observed benefit of H. pylori eradication on perceived improvement of complaints may well be placebo effect.     

Prevalence and incidence of adults consulting for shoulder conditions in UK primary care; patterns of diagnosis and referral

OBJECTIVES: To estimate the national prevalence and incidence of adults consulting for a shoulder condition and to investigate patterns of diagnosis, treatment, consultation and referral 3 yr after initial presentation. METHODS: Prevalence and incidence rates were estimated for 658469 patients aged 18 and over in the year 2000 using a primary care database, the IMS Disease Analyzer-Mediplus UK. A cohort of 9215 incident cases was followed-up prospectively for 3 yr beyond the initial consultation. RESULTS: The annual prevalence and incidence of people consulting for a shoulder condition was 2.36% [95% confidence interval (CI) 2.32-2.40%] and 1.47% (95% CI 1.44-1.50%), respectively. Prevalence increased linearly with age whilst incidence peaked at around 50 yr then remained static at around 2%. Around half of the incident cases consulted once only, while 13.6% were still consulting with a shoulder problem during the third year of follow-up. During the 3 yr following initial presentation, 22.4% of patients were referred to secondary care, 30.8% were prescribed non-steroidal anti-inflammatory drugs and 10.6% were given an injection by their general practitioner (GP). GPs tended to use a limited number of generalized codes when recording a diagnosis; just five of 426 possible Read codes relating to shoulder conditions accounted for 74.6% of the diagnoses of new cases recorded by GPs. CONCLUSIONS: The prevalence of people consulting for shoulder problems in primary care is substantially lower than community-based estimates of shoulder pain. Most referrals occur within 3 months of initial presentation, but only a minority of patients are referred to orthopaedic specialists or rheumatologists. GPs may lack confidence in applying precise diagnoses to shoulder conditions.     

Pain and amyotrophy in upper members in a cirrhotic patient with Pott's disease

We report the case of a 56 year old cirrhotic woman who presented during the course of a tuberculous spondylodiscitis affecting T9-T10, a clinical picture consistent with neuralgic amyotrophy affecting the right shoulder first, and later also the left one (Parsonage-Turner syndrome). This is an uncommonly diagnosed entity of unknown etiology and pathogenesis. Magnetic resonance images (MRI) include high signal intensity in supra and infraspinatus muscles and other muscles of the shoulder girdle, compatible with muscle oedema associated with denervation. These features, combined with the ability of MRI to exclude local problems as tendinitis stresses the importance of this technique in the diagnostic evaluation of patients with neuralgic amyotrophy.     

高频超声对肩周炎愈后肩部疼痛的诊断价值

目的探讨高频超声对肩周炎愈后肩部疼痛的定位和定性诊断价值。方法高频超声检测30例曾患有肩周炎病症、功能恢复后数年肩部出现不同程度疼痛及不适的患者,对声像图进行分析研究。结果将30例患者的声像图分为肱二头肌长头肌腱炎、腱鞘积液（20例）,肩下关节囊增厚表现、回声增强（7例）,肌筋膜增厚、粘连（8例）,软组织、关节内钙化灶（12例）和肩关节周围滑囊炎（2例）等6种表现。结论高频超声对肩周炎后肩部软组织病变可以清晰显示,能做出准确定位和定性诊断,对于临床针对性的治疗具有重要价值。     

High prevalence of symptomatic enthesopathy of the shoulder in ankylosing spondylitis: deltoid origin involvement constitutes a hallmark of disease

OBJECTIVE: To examine the prevalence and characteristics of shoulder involvement in ankylosing spondylitis (AS). To analyze the sensitivity and specificity of shoulder lesions defined by magnetic resonance imaging (MRI) in patients with AS. METHODS: Prevalence of shoulder involvement was ascertained by chart review of 400 AS patients. One hundred of these patients and 285 controls were selected for clinical evaluation. AS patients with a clinically defined shoulder disorder (n = 15) and a control group of 91 patients (94 shoulders) with nonspecific shoulder pain were studied with MRI. Fifty-four MRI-defined variables per shoulder were analyzed by 2 observers. A third cohort of patients with AS (n = 76) was prospectively evaluated by clinical exam for AS-specific shoulder lesions identified on MRI. RESULTS: Shoulder pain was recorded in 3.5% of patients by chart review. Shoulder involvement by clinical evaluation was noted in 24.7% of patients versus 14.2% of controls (odds ratio [OR] 8.17, 95% confidence interval [95% CI] 3.14-21.28, P < 0.001). Rotator cuff tendinitis was significantly more prevalent in patients (15.1%) than controls (3.5%; OR 8.17, 95% CI 2.66-25.14, P < 0.001). Acromioclavicular joint arthrosis was the most common lesion observed in AS shoulders (94%), although specificity was low (32%). Bone marrow edema at any entheseal site was noted in significantly more AS shoulders (70.6%) than in control (19.1%) shoulders (P < 0.001, corrected P = 0.02). Erosion of the greater tuberosity with or without adjacent bone edema had the best combination of sensitivity (58-65%) and specificity (86-92%). Intense acromial entheseal edema at the deltoid origin was observed only in AS shoulders (41.2%; P < 0.001). Evaluation of a prospective cohort of patients with AS showed that 22.4% had rotator cuff enthesopathy. CONCLUSION: Shoulder lesions in AS are common and characterized clinically by rotator cuff tendinitis and on MRI by intense bone edema localized to the supraspinatus/greater tuberosity and deltoid/acromial entheses. Intense acromial bone edema at the deltoid origin is a hitherto undescribed and highly specific feature of AS. Enthesopathy of the rotator cuff is underrecognized in AS and should be incorporated into instruments measuring enthesitis.     

Symptoms, signs, problems, and diseases of terminally ill nursing home patients: a nationwide observational study in the Netherlands

BACKGROUND: Nursing homes (NHs) are less well studied than hospices or hospitals as a setting for terminal care. For more targeted palliative care, more information is needed about the patient characteristics, symptoms, direct causes and underlying diseases, and incidence of terminally ill NH patients. These aspects are examined in this study. METHODS: Prospective observational cohort study in 16 NHs representative of the Netherlands. All long-term care patients assessed by an NH physician to have a life expectancy of 6 weeks or less were enrolled in our study. RESULTS: The terminal disease phase was marked with symptoms of low fluid and food intake, general weakness, and respiratory problems or dyspnea. Direct causes of these conditions were diseases of the respiratory system (mainly pneumonia) and general disorders (eg, cachexia). The 2 main underlying diseases of the terminal phase were mental and behavioral disorders and diseases of the circulatory system. Cancer was the underlying disease in only 12% of the patients. Patients with cancer showed a different pattern of symptoms than those without cancer. Per 100 beds per year, 34 NH patients entered the terminal phase. Most patients (82.9%) died within 7 days of inclusion. CONCLUSIONS: For patients without cancer in Dutch NHs, the terminal disease phase is difficult to predict, and once diagnosed, patient survival time is short. A better identification of the symptom burden might improve the prognostication of life expectancy in elderly patients.     

Effectiveness of treatment of calcific tendinitis of the shoulder by disodium EDTA

Objective

To evaluate the effectiveness of disodium EDTA administration in the treatment of calcific tendinitis of the shoulder.

Methods

Eighty patients with radiographically verified calcific tendinitis of the shoulder were enrolled between September 2001 and October 2003. Patients were randomly assigned to either a study group (n = 40) or a control group (n = 40). Pain and functional level were evaluated before and after treatment and at 1‐year followup. Radiographic modifications in calcifications were evaluated before and after treatment. Disodium EDTA was administered through single needle mesotherapy and 15 minutes of pulsed‐mode 1 MHz‐ultrasound.

Results

The study group displayed improvement in all of the parameters analyzed after treatment and at the 1‐year followup. Calcifications disappeared completely in 62.5% of the patients in the study group and partially in 22.5%; calcifications partially disappeared in only 15% of the patients in the control group, and none displayed a complete disappearance.

Conclusion

Our results suggest that the use of disodium EDTA for the management of calcific tendinitis of the shoulder is safe and effective, leading to a significant reduction in pain, improvement in shoulder function, and disappearance of calcifications after 4 weeks, without adverse effects.     

Abnormal sonographic findings in the asymptomatic arthritic shoulder

OBJECTIVE: To assess the diagnostic value of ultrasonography (US) in the evaluation of arthritic shoulder joints, especially in painless shoulders. METHODS: US examinations were performed in 57 consecutive patients with rheumatoid arthritis (114 shoulders) and in 32 controls (32 shoulders), using a 7.5 MHz linear probe and a standardized study protocol. US findings were compared with clinical, laboratory, and radiological data to find any relationship. RESULTS: Abnormal sonographic findings were found in 80 shoulders (70%); the most common were lesions in the supraspinatus tendon (38%), subacromial-subdeltoid bursitis (29%), bone erosions of the humeral head (20%), glenohumeral joint ellusion (19%), and biceps tendinitis (13%). Although US abnormalities were most frequent in patients with painful shoulders or abnormal findings on physical examination or radiography, a high rate of alterations was found in asymptomatic shoulders (51%), in normal shoulders on physical examination (44%) and in normal shoulders on radiographic assessment (61%). Differences of US findings in relation to time of evolution of rheumatoid arthritis, patient's age, and radiographic stage in hand and/or wrist joints were not found. CONCLUSION: US abnormalities in the shoulder joint are frequent in rheumatoid arthritis, both in patients with and without shoulder complaints as well as in patients with normal findings on physical examination.     

Prevalence and impact of musculoskeletal disorders of the upper limb in the general population

OBJECTIVE: To determine the prevalence, interrelation, and impact of musculoskeletal disorders of the upper limb in the general population. METHODS: A total of 9,696 randomly selected adults of working age were surveyed in a 2-stage cross-sectional study involving a screening questionnaire and a standardized physical examination in symptomatic subjects. Age- and sex-specific prevalence rates were estimated for several musculoskeletal disorders and for nonspecific pain in the upper limbs. The overlap and impact on daily activities and healthcare utilization were explored. RESULTS: Among 6,038 first-stage responders, 3,152 reported upper limb symptoms and 1,960 were subsequently examined. Of subjects with pain, 44.8% had 1 or more specific soft-tissue disorders. Site-specific prevalence rates were as follows: shoulder tendinitis 4.5% among men and 6.1% among women; adhesive capsulitis 8.2% among men and 10.1% among women; lateral epicondylitis 1.3% among men and 1.1% among women; de Quervain's disease 0.5% among men and 1.3% among women; other tenosynovitis of the hand or wrist, 1.1% among men and 2.2% among women. Specific disorders tended to cluster (P < 0.001) in individuals, with particular overlap at the shoulder. Compared with subjects with nonspecific pain, those with specific disorders more often reported inability to perform everyday tasks (P < 0.05), consultation with a doctor (P < 0.05), and use of prescribed medication (P < 0.05). CONCLUSION: Upper limb pain is common in the general population and is often associated with physical signs suggestive of specific upper-limb disorders. These disorders have a substantial impact on physical function and use of health care.     

The responsiveness of the Shoulder Disability Questionnaire

Objective—To evaluate the responsiveness of the Shoulder Disability Questionnaire (SDQ).
Methods—The study was conducted within the framework of an observational study on shoulder disorders in primary care. After first presentation of their complaints to the general practitioner and after one and six months, participants completed the SDQ, a single question on functional status (FSQ), and an ordinal 11 point scale for the severity of pain (PSS). Responsiveness of the SDQ was evaluated compared with that of the FSQ and PSS, by calculating responsiveness ratios and by plotting receiver operating characteristic (ROC) curves. Recovery according to the patient was used as an external criterion for clinically relevant improvement (complete recovery or much improved on a six point Likert scale was denoted as clinically relevant improvement).
Results—A total of 349 consecutive patients with shoulder disorders were enrolled in the observational study. Response rates ranged between 96% and 89%. Responsiveness ratios were slightly higher for the PSS compared with the SDQ (2.53 versus 2.22 at one month, 2.24 versus 1.89 at six months). The area under the ROC curve was 0.84 for both the SDQ and the PSS, and 0.72 for the FSQ.
Conclusion—The results of this study confirm the responsiveness of the SDQ, making it a useful instrument to assess functional disability in longitudinal studies.

Keywords: shoulder; outcome assessment; functional disability; responsiveness     

Felbinac gel for treatment of localized extra-articular rheumatic diseases--a multicenter, placebo controlled, randomized study

281 patients with extra-articular rheumatic disorders (enthesiopathy, bursitis, tendinosis, fibrositis) and moderate or severe localized pain during rest or movement in shoulder, neck, elbow or knee were randomized into groups and treated for 14 days in a double blind study with either 1 g Felbinac Gel 3% (biphenyl acetic acid) three times daily (N = 142) or with the gel formulation only (N = 139). In 50% of the patients treated with Felbinac Gel compared to 29% of the placebo treated patients (p = 0.001), the investigator assessed the global therapeutic success to be good or very good. The magnitude of complaints judged on the basis of a visual analogous scale by patients and doctor showed a significant improvement in pain reduction during rest or activity after 14 days of treatment in the Felbinac group. The rheumatic complaints diminished equally according to patient judgement in both treatment groups and the concomitant use of paracetamol was low in both groups. No significant side-effects or changes in laboratory parameters were observed during therapy. Felbinac Gel therefore is suitable for a low-risk topical therapy of soft tissue rheumatic disorders.