Cacchio 2009a.

Methods	Design: parallel group, 2‐arm, single‐blind RCT (Italy; October 2000 to December 2006). Setting: inpatient and outpatient rehabilitation centre. Interventions: mirror therapy or placebo control (covered mirror). Sample size calculation: 24 participants per group required to detect a 2 cm reduction in pain on a 10 cm VAS (SD 1.5) with 0 cm labelled as "no pain" and 10 cm as "worst pain i have ever had" at 1 week after treatment at 1% level of statistical significance with 90% power, including a 30% rate of loss at follow‐up.
Participants	Number of participants: 48 (24 per group). Type of noxious initiating event: stroke (upper limb). Diagnostic criteria:Bruehl 1999 (CRPS I). Baseline characteristics: conventional stroke rehabilitation plus mirror therapy: mean (SD) age = 57.9 (9.9) years; female:male = 13:11; mean (SD) duration of CRPS I 2.8 (1.3) months; conventional stroke rehabilitation plus placebo control: mean (SD) age = 58.8 (9.4) years; female:male = 13:11; mean (SD) duration of CRPS I 2.6 (1.5) months. Inclusion criteria: first episode of unilateral stroke with hemiparesis during the previous 6 months; VAS, 0 to 10 cm) pain score > 4 cm. Exclusion criteria: ipsilateral intra‐articular shoulder injection within the last 6 months or use of systemic corticosteroids with the previous 4 months; presence of another obvious explanation for the pain; prior surgery to either shoulder or neck region; serious uncontrolled medical conditions; global aphasia, cognitive or visual impairments interfering with testing or treatment; visual impairment that might interfere with the trial aims; evidence of recent drug or alcohol abuse or severe depression.
Interventions	Participants in both groups received 4 weeks of conventional stroke rehabilitation comprising neuro‐rehabilitation techniques, occupational therapy (OT) and speech therapy (if required), consisting of 5 1‐hour sessions per week. Conventional stroke rehabilitation plus mirror therapy (N = 24) Components of intervention: mirror therapy programme: Whilst seated with a mirror board positioned between the upper limbs, perpendicular to the midline and with the unaffected limb facing the reflective surface and with their affected upper limb hidden from view, participants observed the reflection of their unaffected upper limb while performing flexion and extension at the shoulder, elbow and wrist and pronation and supination of the forearm. Dosage: 30 minutes per session (for the first 2 weeks), 1 hour per session (for the second 2 weeks) Frequency of administration: 5 times per week for 4 weeks (20 sessions) Provider: physiotherapist. Conventional stroke rehabilitation plus placebo control (N = 24) Components of intervention: participants performed the same exercises, according to the same dosage and frequency, with the reflective mirror surface covered.
Outcomes	Outcomes assessed at baseline and at 1 week and 6 months post‐treatment. Primary outcomes: self‐rated pain intensity at rest using a 10 cm horizontal VAS labelled "no pain" to "worst pain I have ever had" (pain location not reported); self‐rated pain intensity on shoulder movement (forward flexion) using a 10 cm VAS labelled "no pain" to "worst pain I have ever had"; brush evoked tactile allodynia, assessed by means of 3 brush movements within the area of maximum pain, using a 10 cm VAS labelled "no pain" to "worst pain I have ever had". Secondary outcomes: functional ability value of the Wolf Motor Function Test (WMFT), to assess upper limb functional limitation (score range 0 to 5, higher scores indicate poorer performance); performance time value of the WMFT, to assesses upper limb functional performance speed (measured in seconds, longer times indicate poorer performance); Quality of Movement (QOM) item in the Motor Activity Log (MAL), to assess how well participants can use their affected upper limb in 30 activities of daily living (score range 0 to 5, lower scores indicate poorer performance).
Notes	Source of funding: not reported Statement regarding declarations of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "...we undertook a randomized placebo‐controlled study in which stroke patients with CRPSt I were randomly allocated..." Comment: the trial authors did not report the method of sequence generation.
Allocation concealment (selection bias)	Unclear risk	Comment: the trial authors did not report the method of concealment allocation.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: given the nature of the intervention, participants were not blinded to treatment allocation but the extent to which the lack of blinding may have introduced bias is uncertain.
Blinding of outcome assessment (detection bias) Self‐reported outcomes	Unclear risk	Comment: unblinded participants self‐reported some outcomes (e.g. pain intensity) but the extent to which the lack of blinding may have introduced bias is uncertain.
Blinding of outcome assessment (detection bias) Investigator‐administered outcomes	Low risk	Quote: "All the patients were examined 3 times by an investigator who was blinded to the nature of treatment performed". Comment: the outcome assessor was blinded to treatment allocation.
Incomplete outcome data (attrition bias) Drop‐out rate described and acceptable	Unclear risk	Quote: "Two patients (8%) in the mirror group and 7 patients (29%) in the control group dropped out of the study". Quote: "One of the 2 patients in the mirror group dropped out because he moved to another city, while the other decided to perform corticosteroid injection therapy in another center. Three of the 7 patients in the control group refused to complete the study, while 4 decided to perform corticosteroid injection therapy in another center". Comment: the extent to which an overall drop‐out rate of 19% and an unequal drop‐out rate between groups may have introduced biased estimates of treatment effect is uncertain.
Incomplete outcome data (attrition bias) Participants analysed in the group to which they were allocated	Low risk	Quote: "Both the primary and secondary outcome analyses were performed according to the intention‐to‐treat (ITT) principle. In this study, subjects that provided baseline and at least 1 post‐treatment measurement constituted the ITT population, whereas those who completed all tests from baseline to the 6‐month follow‐up constituted the per protocol population. Comment: the trial authors reported analyses according to the ITT principle.
Selective reporting (reporting bias)	Low risk	Comment: the trial authors fully reported outcome data for all outcomes reported in the methods section of the publication.
Sample size	High risk	Quote: "48 patients with CRPSt1 of the affected upper limb were enrolled". Comment: the small sample size may have introduced bias in estimates of treatment effect.
Duration of follow‐up	Low risk	Quote: "The decision to set the follow‐up at 6 months is based on the hypothesis that pain improves spontaneously over a long period of time". Comment: the trial authors measured outcomes over a clinically relevant length of time.
Other bias	High risk	Quote: "For the ITT population, outcome measurements were analyzed using the last observation carried forward method". Comment: the use of 'last observation carried forward' when accounting for missing data may have introduced bias in estimates of treatment effect.