Jacques Geraets

Effectiveness of a graded exercise therapy program for patients with chronic shoulder complaints

An operant behavioural and time-contingent graded exercise therapy program was developed to improve functional ability irrespective of pain experience in patients with chronic shoulder complaints. The clinical effectiveness of graded exercise therapy compared to usual care was evaluated in a randomised clinical trial. Assessments were carried out before and after 12 weeks of treatment. Performance of daily activities was measured by two outcome measures: the main complaints instrument and the Shoulder Disability Questionnaire (SDQ). Patients were eligible for participation if they had suffered from shoulder complaints for at least three months. Patients suffering from systemic diseases, referred pain or severe biomedical or psychiatric disorders were excluded. Patients (n = 176) were randomised and allocated either to graded exercise therapy (n = 87) or usual care (n = 89). Graded exercise therapy led to greater improvement in the performance of daily activities than usual care. However, only mean differences between groups in performance of activities related to the main complaints reached statistical significance (p = 0.049; 95% CI 0.0 to 15.0). The observed beneficial effects were considered to be small to moderate (calculated effect sizes: 0.30 for the main complaints instrument and 0.07 for the SDQ). Subgroup analysis showed larger improvements on the mean complaints instrument in patients not reporting pain reduction over time. Graded exercise therapy seems to be less effective in restoring performance of daily activities as assessed by the SDQ in patients showing a painful arc during physical examination. Results showed that graded exercise therapy is more effective in restoring the ability to daily activities in patients with chronic shoulder complaints than usual care, although beneficial effects are small.

Cost-effectiveness of a graded exercise therapy program for patients with chronic shoulder complaints.

OBJECTIVES The present study evaluated the cost-effectiveness of a behavioral graded exercise therapy (GET) program compared with usual care (UC) in terms of the performance of daily activities by patients with chronic shoulder complaints in primary care. METHODS A total of 176 patients were randomly assigned either to GET (n=87) or to UC (n=89). Clinical outcomes (main complaints, shoulder disability [SDQ] and generic health-related quality of life [EQ-5D], and costs [intervention costs, direct health care costs, direct non-health-related costs, and indirect costs]) were assessed during the 12-week treatment period and at 52 weeks of follow-up. RESULTS Results showed that GET was more effective than UC in restoring daily activities as assessed by the main complaints instrument after the 12-week treatment period (p = .049; mean difference, 7.5; confidence interval [CI], 0.0-15.0). These effects lasted for at least 52 weeks (p = .025; mean difference 9.2; CI, 1.2-17.3). No statistically significant differences were found on the SDQ or EQ5D. GET significantly reduced direct health care costs (p = .000) and direct non-health care costs (p = .029). Nevertheless, total costs during the 1-year follow-up period were significantly higher (p = .001; GET = Euro 530 versus UC = Euro 377) due to the higher costs of the intervention. Incremental cost-effectiveness ratios for the main complaints (0-100), SDQ (0-100), and EQ-5D (-1.0-1.0) were Euro 7, Euro 74, and Euro 5278 per unit of improvement, respectively. CONCLUSIONS GET proved to be more effective in the short- and long-term and reduces direct health care costs and direct non-health care costs but is associated with higher costs of the intervention itself.

A behavioural treatment for chronic shoulder complaints: Concepts, development, and study design

This paper discusses the rationale for and content of a newly developed treatment for shoulder complaints, and describes a randomised study which is currently being conducted to test effectiveness of the treatment. In current practice, approximately 50% of all patients with shoulder complaints mention limitations in the performance of daily activities and persisting pain after six months. To improve the functional ability of patients with chronic shoulder complaints, despite their pain, we have developed an operant behavioural and time-contingent graded exercise therapy programme for use in a primary care setting. We present the theory and conceptual model underlying this programme, report on its development and content, and describe the design of a randomised clinical trial to evaluate the programmes effectiveness and cost-effectiveness. One hundred and thirty-two patients who suffer from shoulder complaints for at least 3 months are being recruited in general practice. After inclusion in the study, patients are allocated randomly to the graded exercise therapy programme or to usual care. Questionnaires will be used to measure factors like severity of the main complaint, functional limitations of daily activities, perceived recovery, global health status, shoulder pain, generic health-related quality of life, and costs. These factors will be assessed at baseline, during treatment (6 weeks), and after treatment (12, 26, and 52 weeks).

Cost-effectiveness of an education and activation program for patients with acute and subacute shoulder complaints compared to usual care

OBJECTIVES Shoulder complaints (SCs) constitute the second largest group of musculoskeletal disorders after low back pain. The economic burden in terms of costs of healthcare use and costs due to work absenteeism underlines the need for a cost-effectiveness analysis of the interventions involved. The education and activation program (EAP) is a newly developed early intervention to prevent the development of chronic SCs. A cost-effectiveness analysis should provide more information on the effect of an EAP on total costs related to SCs. METHODS We conducted a cost-effectiveness analysis alongside a randomized clinical trial comparing the effectiveness of the EAP in addition to usual care (EAP group) with that of usual care alone (UC group) in terms of preventing chronicity in patients with acute SCs. The aim of the cost-effectiveness analysis was to compare the observed difference in costs with the clinical effectiveness (i.e., patient-perceived recovery after 26 weeks), using bootstraps. RESULTS The comparison of total costs between treatment groups showed no significant (p = .077) difference after 26 weeks. The majority (82 percent) of the cost-effect pairs after bootstrap analysis were located in the northeast quadrant, suggesting more effect but at higher costs. CONCLUSIONS In view of the clinical relevance of the clinical outcomes and the considerable costs needed to achieve this, it can be concluded that the EAP is currently not cost-effective.

Evaluation of an education and activation programme to prevent chronic shoulder complaints: design of an RCT [ISRCTN71777817]

BackgroundAbout half of all newly presented episodes of shoulder complaints (SC) in general practice are reported to last for at least six months. Early interventions aimed at the psychological and social determinants of SC are not common in general practice, although such interventions might prevent the development of chronic SC.The Education and Activation Programme (EAP) consists of an educational part and a time-contingent activation part. The aim of the EAP is to provide patients with the proper cognitions by means of education, and to stimulate adequate behaviour through advice on activities of daily living.DesignThe article describes the design of a randomised clinical trial (RCT) to evaluate the effectiveness and cost-effectiveness of an EAP in addition to usual care, compared to usual care only, in the prevention of chronic SC after six months. It also describes the analysis of the cost and effect balance. Patients suffering from SC for less than three months are recruited in general practice and through open recruitment. A trained general practitioner or a trained therapist administers the EAP.Primary outcome measures are patient-perceived recovery, measured by self-assessment on a seven-point scale, and functional limitations in activities of daily living. Questionnaires are used to study baseline measures, prognostic measures, process measures and outcome measures.DiscussionThe inclusion of patients in the study lasted until December 31st 2003. Data collection is to end in June 2004.

Effect of an education and activation programme on functional limitations and patient-perceived recovery in acute and sub-acute shoulder complaints - a randomised clinical trial

BackgroundThe education and activation programme (EAP) aims at coping with psychosocial determinants to prevent the development of chronic shoulder complaints (SCs). The effect of the EAP on functional limitations and patient-perceived recovery after 6 and 26 weeks is evaluated in a randomised clinical trial.MethodsPatients with SCs present at rest or elicited by movement and lasting no longer than 3 months were allocated at random to either EAP as an addition to usual care (UC), or to UC only. Measurements were taken at baseline and after 6 and 26 weeks and were analysed by means of multilevel analysis for the group effect. EAP was administered by GPs or by an ambulant therapist (CDB). Patients in the UC group were given UC by their own GP.ResultsMultilevel analysis failed to show a significant effect of the EAP on either functional limitations or patient-perceived recovery. Analysis showed coincidentally a relation between catastrophising at baseline and functional limitations.ConclusionThe EAP has no significant effect on the outcome of SCs after 6 and 26 weeks. The relation between catastrophising at baseline and functional limitations suggests that an intervention focusing specifically on catastrophising may be more successful in reducing functional limitations in the long term. Further research is however needed to evaluate the effect of catastrophising at baseline on the course of SCs.Trial registrationCurrent Controlled Trials ISRCTN71777817

General practitioners apply the usual care for shoulder complaints better than expected - analysis of videotaped consultations

BackgroundThe education and activation program (EAP) is a newly developed intervention to prevent the development of chronic shoulder complaints (SCs). Trained general practitioners (GPs) administer the EAP. The EAP addresses inadequate cognitions and maladaptive behavior related to the SCs. The effect of the EAP is evaluated in a randomized clinical trial.The aim of the present study is to use videotaped consultations to study (1) the performance of trained GPs administering the EAP and (2) the presence of key features of the EAP already embedded in usual care (UC).MethodsFive trained GPs were videotaped while treating a standardized patient with EAP. Additionally, five GPs administering UC were videotaped. Two blinded observers evaluated the videotapes in relation to key features of the EAP which were scored on the EAP checklist.ResultsThe mean total score on the EAP checklist was 4.7 (SD = 2.9) for the UC group and 7.1 (SD = 2.1) for the EAP group. Neither group reached a score higher than 8, which was considered to reflect an acceptable number of key EAP features.ConclusionOur comparison of the presence of key features of EAP shows that the UC and EAP groups differed less than was expected. GPs in the UC group performed above expectation, with a mean total score of 4.7. Moreover, the low number of key features present in the EAP group may very well have led to a reduced effectiveness of the EAP. The results of this study can be used to optimize the training of GPs using the EAP.

Mogelijkheden voor cognitief-gedragsmatige behandeling van schouderklachten in de eerste lijn

Op dit moment is het nog onduidelijk of cognitief-gedragsmatige behandelingen effectief zijn bij de preventie en behandeling van chronische schouderklachten. Mogelijk dat een minimale cognitief-gedragsmatige behandeling van acute en subacute schouderklachten van de kant van de huisarts of de fysiotherapeut chroniciteit kan voorkomen. De veronderstelling is dat een cognitief-gedragsmatige behandeling in de acute en subacute fase van schouderklachten kan voorkomen dat onjuiste cognities en ongewenst pijngedrag ontstaan die het verder herstel kunnen belemmeren.

Hoofdstuk 17 Graded activity als behandeling voor patiënten met chronische schouderklachten in de eerste lijn

Schouderklachten vormen een veelvoorkomende aandoening met een vrij groot aandeel aan recidiverende en chronische problemen. In dit onderzoek werd de effectiviteit van een graded activity-programma, gebaseerd op de principes van gradueel oefenen, operante conditionering en tijdcontingentie, gericht op een toename van de dagelijkse activiteiten van patienten met chronische schouderklachten in de eerste lijn, onderzocht. Ga blijkt in dit opzicht effectiever te zijn dan de gebruikelijke behandeling voor schouderklachten conform de nhg-standaard (‘usual care’, uc). De verschillen tussen de behandelgroepen direct na afloop van de behandeling zijn klein, maar beklijven gedurende de follow-upperiode gemeten na 26 en 52 weken. Ga is met name effectief in de behandeling van patienten bij wie de pijnintensiteit gedurende de behandeling niet is verminderd. Ga is niet effectiever dan uc in de behandeling van patienten die in het lichamelijk onderzoek een ‘painful arc’ vertoonden. Verder draagt ga bij aan het verminderen van catastroferende gedachten, vrees-vermijdingsgedrag en kinesiofobie bij patienten met chronische schouderklachten.