Cacchio 2009a
| Methods | RCT | |
| Participants | Country: Italy Sample size: 48 participants (24 in each group; 6 dropped out post‐treatment, 3 more dropped out after 6 months) Inclusion criteria: hemiparesis after first ever ischaemic or haemorrhagic stroke; during first 6 months post‐stroke; diagnosed with CRPS‐type 1 with a VAS pain score > 4 cm Exclusion criteria: an intra‐articular injection into the affected shoulder during the previous 6 months or use of systemic corticosteroids during the previous 4 months; presence of another explanation of pain; prior surgery to shoulder or neck; serious uncontrolled medical conditions; global aphasia or cognitive impairments; visual impairments which might interfere with the aims of the study; evidence of recent alcohol or drug abuse; or severe depression |
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| Interventions | 2 arms: 4‐week conventional stroke rehabilitation programme and additional
1 and 2: 5 days a week, 30 minutes of therapy for the first 2 weeks; and 5 days a week, 60 minutes of therapy for the last 2 weeks |
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| Outcomes | Outcomes were recorded at baseline, 1 week after the intervention period and after 6 months
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| Notes | Published and unpublished data | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Patients were randomly allocated (authors' statement) |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| ITT analysis | Low risk | Results were analysed on an ITT basis |
| Blinding of outcome assessment (detection bias) primary outcome | Low risk | Assessors were blinded to group allocation |