Manipulative therapy in addition to usual medical care accelerates recovery of shoulder complaints at higher costs: economic outcomes of a randomized trial.

BACKGROUND: Shoulder complaints are common in primary care and have unfavourable long term prognosis. Our objective was to evaluate the clinical effectiveness of manipulative therapy of the cervicothoracic spine and the adjacent ribs in addition to usual medical care (UMC) by the general practitioner in the treatment of shoulder complaints. METHODS: This economic evaluation was conducted alongside a randomized trial in primary care. Included were 150 patients with shoulder complaints and a dysfunction of the cervicothoracic spine and adjacent ribs. Patients were treated with UMC (NSAID's, corticosteroid injection or referral to physical therapy) and were allocated at random (yes/no) to manipulative therapy (manipulation and mobilization). Patient perceived recovery, severity of main complaint, shoulder pain, disability and general health were outcome measures. Data about direct and indirect costs were collected by means of a cost diary. RESULTS: Manipulative therapy as add-on to UMC accelerated recovery on all outcome measures included. At 26 weeks after randomization, both groups reported similar recovery rates (41% vs. 38%), but the difference between groups in improvement of severity of the main complaint, shoulder pain and disability sustained. Compared to the UMC group the total costs were higher in the manipulative group (€1167 vs. €555). This is explained mainly by the costs of the manipulative therapy itself and the higher costs due sick leave from work. The cost effectiveness ratio showed that additional manipulative treatment is more costly but also more effective than UMC alone. The cost-effectiveness acceptability curve shows that a 50%-probability of recovery with AMT within 6 months after initiation of treatment is achieved at €2876. CONCLUSION: Manipulative therapy in addition to UMC accelerates recovery and is more effective than UMC alone on the long term, but is associated with higher costs. INTERNATIONAL STANDARD RANDOMIZED CONTROLLED TRIAL NUMBER REGISTER: ISRCTN11216.

Manipulative therapy in addition to usual care for patients with shoulder complaints: results of physical examination outcomes in a randomized controlled trial.

OBJECTIVE: The purpose of this study was to examine the effect of manipulative therapy on the shoulder girdle, in addition to usual care provided by the general practitioner, on the outcomes of physical examination tests for the treatment of shoulder complaints. METHODS: This was a randomized controlled trial in a primary care setting in the Netherlands. A total of 150 participants were recruited from December 2000 until December 2002. All patients received usual care by the general practitioner. Usual care included one or more of the following depending on the needs of the patient: information/advice, oral analgesics or nonsteroidal antiinflammatory drugs, corticosteroid injections, exercises, and massage. In addition to usual care, the intervention group received manipulative therapy, up to 6 treatment sessions in a 12-week period. Twenty-four physical examination tests were done at baseline and after 6, 12, and 26 weeks. Factor analysis was done to reduce the number of outcome measures. RESULTS: The factor analysis resulted in 4 factors: "shoulder pain," "neck pain," "shoulder mobility," and "neck mobility." At 6 weeks, no significant differences between groups were found. At 12 weeks, the mean changes of all 4 factors favored the intervention group; the factors "shoulder pain" and "neck pain" reached statistical significance (95% confidence interval [CI], 0.1-2.1). At 26 weeks, differences in the factors "shoulder pain" (95% CI, 0.0-2.6), "shoulder mobility" (95% CI, 0.2-1.7), and "mobility neck" (95% CI, 0.2-1.3) statistically favored the intervention group. CONCLUSION: In this pragmatic study, manipulative therapy, in addition to usual care by the general practitioner, diminished severity of shoulder pain and neck pain and improved shoulder and neck mobility.

Chromium treatment has no effect in patients with poorly controlled, insulin-treated type 2 diabetes in an obese Western population: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: Chromium treatment has been reported to improve glycemic control and insulin sensitivity in specific populations of patients with type 2 diabetes. The aim of this study was to determine the effect of chromium treatment on glycemic control in a Western population of insulin-dependent patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: In this 6-month double-blind study, patients with an HbA(1c) (A1C) >8% and insulin requirements of >50 units/day were randomly assigned to receive treatment with placebo or 500 or 1,000 mug chromium daily in the form of chromium picolinate. The primary efficacy parameter was a change in A1C. Secondary end points were changes in lipid profile, BMI, blood pressure, and insulin requirements. RESULTS: In this per-protocol analysis (n = 46), the decrease in A1C was approximately equal across the three groups (0.4%). All patients had a BMI >25 kg/m(2). No differences were found in the secondary end points. We found a weak relationship between an increasing serum chromium concentration and improvement of the lipid profile. CONCLUSIONS: There is no evidence that high-dose chromium treatment is effective in obese Western patients with type 2 diabetes.

Manipulative therapy in addition to usual medical care for patients with shoulder dysfunction and pain: a randomized, controlled trial.

BACKGROUND: Dysfunction of the cervicothoracic spine and the adjacent ribs (also called the shoulder girdle) is considered to predict occurrence and poor outcome of shoulder symptoms. It can be treated with manipulative therapy, but scientific evidence for the effectiveness of such therapy is lacking. OBJECTIVE: To study the effectiveness of manipulative therapy for the shoulder girdle in addition to usual medical care for relief of shoulder pain and dysfunction. DESIGN: Randomized, controlled trial. SETTING: General practices in Groningen, the Netherlands. PATIENTS: 150 patients with shoulder symptoms and dysfunction of the shoulder girdle. INTERVENTIONS: All patients received usual medical care from their general practitioners. Only the intervention group received additional manipulative therapy, up to 6 treatment sessions in a 12-week period. MEASUREMENTS: Patient-perceived recovery, severity of the main complaint, shoulder pain, shoulder disability, and general health. Data were collected during and at the end of the treatment period (at 6 and 12 weeks) and during the follow-up period (at 26 and 52 weeks). RESULTS: During treatment (6 weeks), no significant differences were found between study groups. After completion of treatment (12 weeks), 43% of the intervention group and 21% of the control group reported full recovery. After 52 weeks, approximately the same difference in recovery rate (17 percentage points) was seen between groups. During the intervention and follow-up periods, a consistent between-group difference in severity of the main complaint, shoulder pain and disability, and general health favored additional manipulative therapy. LIMITATIONS: The sample size was small, and assessment of end points was subjective. CONCLUSION: Manipulative therapy for the shoulder girdle in addition to usual medical care accelerates recovery of shoulder symptoms.

Groningen Manipulation Study. The effect of manipulation of the structures of the shoulder girdle as additional treatment for symptom relief and for prevention of chronicity or recurrence of shoulder symptoms. Design of a randomized controlled trial within a comprehensive prognostic cohort study.

BACKGROUND: We present the design of the Groningen Manipulation Study. This randomized controlled trial is part of the Dutch Shoulder Disability Study, a comprehensive prognostic cohort study on shoulder disorders, with randomized controlled interventions in subcohorts. OBJECTIVE: To evaluate the effectiveness of manipulative treatment of the structures of the shoulder girdle, in addition to standard treatment by the general practitioner for relief of shoulder symptoms and prevention of persistent or recurrent shoulder symptoms. METHODS: A total of 250 patients with shoulder symptoms and a functional limitation of the shoulder girdle will be included from 30 general practices in Groningen, The Netherlands. All participating patients receive standard treatment by the general practitioner and will be randomly allocated to additional manipulative treatment. Evaluation measurements take place 6, 12, 26, and 52 weeks after randomization. CONCLUSION: The short-term primary outcome measure is the proportion of patients with relief of shoulder complaints and the long-term primary outcome is the proportion of patients without persistent or recurrent shoulder symptoms. Dependent and independent variables include a structured medical history, a physical examination of the shoulder and shoulder girdle, and a measure of the mobility of the cervico-thoracic spine with a 6-degree-of-freedom electromagnetic tracking device.

Effect of an increased intake of alpha-linolenic acid and group nutritional education on cardiovascular risk factors: the Mediterranean Alpha-linolenic Enriched Groningen Dietary Intervention (MARGARIN) study.

BACKGROUND: The effect of long-term increased intakes of alpha-linolenic acid (ALA; 18:3n-3) on cardiovascular risk factors is unknown. OBJECTIVES: Our objectives were to assess the effect of increased ALA intakes on cardiovascular risk factors and the estimated risk of ischemic heart disease (IHD) at 2 y and the effect of nutritional education on dietary habits. DESIGN: Subjects with multiple cardiovascular risk factors (124 men and 158 women) were randomly assigned in a double-blind fashion to consume a margarine rich in either ALA [46% linoleic acid (LA; 18:2n-6) and 15% ALA; n = 114] or LA (58% LA and 0.3% ALA; n = 168). An intervention group (n = 110; 50% ALA) obtained group nutritional education, and a control group (n = 172; 34% ALA) received a posted leaflet containing the standard Dutch dietary guidelines. RESULTS: Average ALA intakes were 6.3 and 1.0 g/d in the ALA and LA groups, respectively. After 2 y, the ALA group had a higher ratio of total to HDL cholesterol (+0.34; 95% CI: 0.12, 0.56), lower HDL cholesterol (-0.05 mmol/L; -0.10, 0), higher serum triacylglycerol (+0.24 mmol/L; 0.02, 0.46), and lower plasma fibrinogen (-0.18 g/L; -0.31, -0.04; after 1 y) than did the LA group (adjusted for baseline values, sex, and lipid-lowering drugs). No significant difference existed in 10-y estimated IHD risk. After 2 y, the intervention group had lower saturated fat intakes and higher fish intakes than did the control group. CONCLUSIONS: Increased ALA intakes decrease the estimated IHD risk to an extent similar to that found with increased LA intakes. Group nutritional education can effectively increase fish intake.