Objectives. The aim of this trial was to evaluate the difference in treatment effect, at 26 and 52 weeks after the start of treatment, between cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation treatment (MRT) for patients with chronic fatigue syndrome (CFS).Design. Multicentre, randomized controlled trial of patients with CFS. Participants were randomly assigned to MRT or CBT.Setting. Four rehabilitation centres in the Netherlands. Subjects. A total of 122 patients participated in the trial.Main outcome measures. Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36. Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation.Results. A total of 114 participants completed the assessment at 26 weeks, and 112 completed the assessment at 52 weeks. MRT was significantly more effective than CBT in reducing fatigue at 52 weeks. The estimated difference in fatigue between the two treatments was À3.02 [95% confidence interval (CI) À8.07 to 2.03; P = 0.24] at 26 weeks and À5.69 (95% CI À10.62 to À0.76; P = 0.02) at 52 weeks. Patients showed an improvement in quality of life over time, but between-group differences were not significant. Conclusion.This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS. Although implementation in comparable populations can be recommended based on clinical effectiveness, it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial.

The aim of the study was to evaluate the use of prostheses, some secondary complications and functional aspects among children who had a congenital leg deficiency or an acquired leg amputation. Rehabilitation physicians were asked to refer children, aged 1-18 years, with a leg deficiency or amputation. Mentally retarded children, children who had only had a toe amputated and children within one year after amputation were excluded. A total of 88 children were included; 64 with a congenital deficiency and 24 with an acquired amputation. In 25 of these 88, both legs were affected; 28 children also had an arm deficiency or amputation. A structured interview was held and the Child-HAQ assessed. Five (5) questions from the Child-HAQ, all relating to leg functions, were analysed. All but 7 children had had a prosthesis fitted, most (89%) using it for almost the entire day. In the children with congenital deficiencies, the first prosthesis had been fitted at an average age of approximately 18 months. Four (4) of the 7 children without prostheses used orthopaedic footwear. The 10 children with congenital deficiencies necessitating prostheses with articulated knees had the first knee of this type fitted at an average age of approximately 37 months. Forty-seven (47) of the 88 children had needed one or more (secondary) operations. In the children with congenital deficiencies, this was usually a conversion procedure, while the children with an acquired amputation had usually been operated on for osseous overgrowth. Twenty (20) of the 88 children experienced or had previously experienced phantom sensations, 5 children phantom pain. Skin problems were common. Most children (95%) were able to walk, most of them (93%) more than 100 m and 93% of the children aged 4 years or over were able to cycle. Most children (94%) aged 6 years or over were able to don and doff their prostheses independently. Some 90% of the children aged 4 years or over attended a normal primary or secondary school. Most (93%) of the children were able to take part in the physical education programme at school, although frequently (47%) with some degree of difficulty. The functional abilities of 88 Dutch children with congenital leg deficiencies or leg amputations were found to be generally satisfactory. Most of the children used prostheses in their daily activities. Secondary complications were, however, frequent.

Information on the characteristics

BackgroundPatients with chronic fatigue syndrome experience extreme fatigue, which often leads to substantial limitations of occupational, educational, social and personal activities. Currently, there is no consensus regarding the treatment. Patients try many different therapies to overcome their fatigue. Although there is no consensus, cognitive behavioural therapy is seen as one of the most effective treatments. Little is known about multidisciplinary rehabilitation treatment, a combination of cognitive behavioural therapy with principles of mindfulness, gradual increase of activities, body awareness therapy and pacing. The difference in effectiveness and cost-effectiveness between multidisciplinary rehabilitation treatment and cognitive behavioural therapy is as yet unknown. The FatiGo (Fatigue-Go) trial aims to compare the effects of both treatment approaches in outpatient rehabilitation on fatigue severity and quality of life in patients with chronic fatigue syndrome.MethodsOne hundred twenty patients who meet the criteria of chronic fatigue syndrome, fulfil the inclusion criteria and sign the informed consent form will be recruited. Both treatments take 6 months to complete. The outcome will be assessed at 6 and 12 months after the start of treatment. Two weeks after the start of treatment, expectancy and credibility will be measured, and patients will be asked to write down their personal goals and score their current performance on these goals on a visual analogue scale. At 6 and 14 weeks after the start of treatment, the primary outcome and three potential mediators—self-efficacy, causal attributions and present-centred attention-awareness—will be measured. Primary outcomes are fatigue severity and quality of life. Secondary outcomes are physical activity, psychological symptoms, self-efficacy, causal attributions, impact of disease on emotional and physical functioning, present-centred attention-awareness, life satisfaction, patient personal goals, self-rated improvement and economic costs. The primary analysis will be based on intention to treat, and longitudinal analysis of covariance will be used to compare treatments.DiscussionThe results of the trial will provide information on the effects of cognitive behavioural therapy and multidisciplinary rehabilitation treatment at 6 and 12 months follow-up, mediators of the outcome, cost-effectiveness, cost-utility, and the influence of treatment expectancy and credibility on the effectiveness of both treatments in patients with chronic fatigue syndrome.Trial registrationCurrent Controlled Trials ISRCTN77567702.

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