Schreuders 2014.
Methods |
Design: parallel group, 2‐arm, single‐blind RCT (The Netherlands; dates not reported). Setting: not reported. Interventions: GMI programme plus conventional treatment or conventional treatment alone. Sample size calculation: not reported. |
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Participants |
Number of participants: 18 (experimental group N = 11, control group N = 7). Type of noxious initiating event: not reported (upper limb). Diagnostic criteria:Bruehl 1999 (CRPS I). Baseline characteristics:
Inclusion criteria:
Exclusion criteria: not reported |
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Interventions | All participants received conventional treatment including a 6‐week OT and physiotherapy programme, including training of grip function, muscle strengthening and joint mobility interventions, writing exercises and advice to reduce the use of splints. Participants were asked not to participate in other treatment programmes during the 12‐week period and not to change the type or dosage medication of their medication unless instructed to do so by their physician. GMI programme (N = 11) Components of intervention:
Dosage: 10 minutes. Frequency of administration: every hour (3 times per day minimum) for a total of 6 weeks. Provider: therapists (distinction between physio‐ and occupational therapist not reported). Standard care (N = 7) Components of intervention:
Dosage: 60 minutes per week (over 1 or 2 sessions). Frequency of administration: 1 or 2 sessions per week, for 6 weeks. Provider: physical therapists and occupational therapists. |
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Outcomes | Outcomes were assessed at baseline and after 3, 6 (immediately post‐treatment) and 12 weeks (6 weeks post‐treatment) post enrolment. Primary outcomes:
Secondary outcomes: fine hand coordination of both hands by using the Nine Hole Peg Test (recorded in seconds). |
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Notes |
Source of funding: ErasmusMC Mrace Project Zorg 2004‐20, grant number 2004‐20. Statement regarding declarations of interest: the trial authors declared no conflicts of interest. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Based on a computerized random schedule..." Comment: the trial authors used an acceptable method to generate the sequence allocation. |
Allocation concealment (selection bias) | Low risk | Quote: "Based on a computerized random schedule, a researcher not involved in the execution of the trial, made a sequence of numbered opaque envelopes. These envelopes were prepared with equality being achieved after every ten subjects (block size 10)". Quote: "Envelopes were given in sequence of entry to the patient and were opened by the patient". Comment: the trial authors used an acceptable method to conceal the allocation sequence. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Patients were not blinded to the treatment as they were aware of the treatment content". Comment: given the nature of the intervention, participants were not blinded to treatment and may have had different expectations about the benefits of each intervention. |
Blinding of outcome assessment (detection bias) Self‐reported outcomes | High risk | Comment: unblinded participants, who may have had different expectations about the benefits of the intervention they received, self‐reported some outcomes (e.g. pain intensity). |
Blinding of outcome assessment (detection bias) Investigator‐administered outcomes | Low risk | Quote: "The assessor was blinded for the allocation to the experimental or control group". Quote: "The measurements were performed by trained blinded assessors". Comment: the trial authors blinded outcome assessors to participant group allocation |
Incomplete outcome data (attrition bias) Drop‐out rate described and acceptable | High risk | Comment: the trial authors did not adequately report drop‐out rate in the 'Results' section of the manuscript. Comment: according to 'Figure 2' of the manuscript, 1 participant was lost to follow‐up and 2 discontinued the intervention from the experimental group, 1 participant withdrew after randomisation, 1 participant was lost to follow‐up and 3 discontinued the intervention from the conventional treatment group, giving drop‐out rates of 27% and 71% respectively, and an overall drop‐out rate of 44%. Comment: the high drop‐out rate may have introduced bias in estimates of treatment effect. |
Incomplete outcome data (attrition bias) Participants analysed in the group to which they were allocated | High risk | Comment: the trial authors reported analysis as ITT in Figure 2 of the unpublished manuscript. Quote: "Three patients (one in the experimental group, two in the control group) could not be included in the analysis due to insufficient compliance in filling out the VAS and RASQ questionnaires or because of immediate withdrawal from the control therapy because the participants only wanted the graded MIP". Comment: violation of the principle of ITT analysis may have introduced bias in estimates of treatment effect. Quote: "From seven of the remaining fifteen patients (five in the experimental group and two in the control group) there were missing end‐tests" (i.e. at 12 weeks post enrolment/6 weeks postintervention). Quote: "Differences in changes in both groups over times were tested using a generalized estimating equations (GEE) approach. Under the assumption that missing data were random and not due to group allocation or treatment effect, this model estimates missing data values, thereby allowing the use of data from all participants, irrespective of whether they were measured at all time points". Comment: use of GEE may have introduced bias in estimates of treatment effect. |
Selective reporting (reporting bias) | High risk | Comment: the trial authors reported outcome data graphically for all self‐reported pain outcomes; and did not report raw data in numerical form with measures of variation. The trial authors presented effect sizes with measures of variation for the Radboud Skills Questionnaire and Nine Hole Peg Test; and did not report numerical data with measures of variation. |
Sample size | High risk | Quote: "For this trial eighteen patients were included". Quote: "For this study only 18 patients were assessed for eligibility and only 15 of them could be included in the analysis. The number of patients in the study was therefore too small to detect possible effects with the intended power for which 52 patients were needed". Comment: the small sample size may have introduced bias in estimates of treatment effect. |
Duration of follow‐up | Unclear risk | Quote: "Outcome was assessed at baseline, after 3, 6 and 12 [i.e. 6 weeks post‐treatment] weeks". Comment: the clinical relevance of a 6‐week follow‐up of outcomes is uncertain. |
Other bias | High risk | Comment: baseline data for 3 participants excluded from the analysis not reported. Comment: likely highly significant baseline imbalance in duration of symptoms between groups. |