Dacre 1989.
Methods |
Design: parallel‐group, 3‐arm, single‐blind randomised controlled trial (United Kingdom) Interventions: physiotherapy (mobilisation) or local glucocorticoid injection or physiotherapy (mobilisation) plus local glucocorticoid injection for 6 weeks Sample size calculation: not reported Analysis: per‐protocol analysis Source of funding: Arthritis and Rheumatism Council (non‐industry) |
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Participants |
Number of participants: 66 (20, 22 and 20 in each respective group) Baseline characteristics: duration of symptoms not reported Group receiving physiotherapy (mobilisation) Mean age = 53 years; male:female = 9:11 Group receiving local glucocorticoid injection Mean age = 55.8 years; male:female = 11:11 Group receiving physiotherapy (mobilisation) plus local glucocorticoid injection Mean age = 58.8 years; male:female = 8:12 Inclusion criteria
Exclusion criterion
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Interventions |
Physiotherapy (mobilisation) (N = 20) Components of intervention
Dosage: not reported Frequency of administration: 4‐6 weeks (4‐6 sessions) Provider: physiotherapist Local glucocorticoid injection (N = 22) Components of intervention: 20 mg triamcinolone with 1 mL 2% lignocaine injected anteriorly around the shoulder joint Dosage: See above Frequency of administration: once Provider: rheumatologist Physiotherapy (mobilisation) plus local glucocortcoid injection (N = 20) Combination of both interventions described above |
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Outcomes | Outcomes assessed at 6 weeks (end of physiotherapy treatment) and at 6 months. No primary outcome reported by the trialists
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Notes | Trialists reported means (standard errors) for each group in figure format for day pain, pain on active movement, total abduction and internal rotation, but no data for night pain, pain on passive movement, glenohumeral abduction and external rotation. No numerical data were reported for any outcome. The study authors were contacted in an attempt to access additional data, but attempts have been unsuccessful. DigitizeIt was used to extract data from figures Trialists reported in the Discussion section, "No treatment gave complications" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly allocated to receive physiotherapy alone, local steroid injection alone, or a combination of the two" Comment: No information was reported about how the allocation sequence was generated |
Allocation concealment (selection bias) | Unclear risk | Comment: No information was reported about how the allocation sequence was concealed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Given the nature of the interventions, participants were not blind 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 pain |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: "Patients were assessed initially, at six weeks, and at six months by an independent observer unaware of the treatment given" Comment: Assessors of the outcome, passive range of motion, were probably blind to treatment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Four patients dropped out of the study before completion. They failed to attend for review at six weeks or six months. The analysis was based on 62 patients (34 female, 28 male)" Comment: The number of participants randomly assigned to each group and the number who dropped out of each group were not reported. Also, it is unclear whether failure of participants to attend for review was related to the treatment they received. Despite this, the relatively low dropout rate is unlikely to have biased the results |
Selective reporting (reporting bias) | High risk | Comment: Trialists reported means (standard errors) for each group in figure format for day pain, pain on active movement, total abduction and internal rotation, but no data for night pain, pain on passive movement, glenohumeral abduction and external rotation |
Other bias | Low risk | Comment: No other sources of bias were identified |