Bache 2001.
| Methods | Method of randomisation: sealed envelopes contained in a box Assessor blinding: yes for objective measures; some participants revealed their treatment despite requests not to do so beforehand Intention‐to‐treat analysis: likely, but post‐randomisation exclusions: 4 developed CRPS‐1 and 1 developed carpal tunnel syndrome Loss to follow‐up: 18 (+ above 5 exclusions) (at 12 weeks) | |
| Participants | Selly Oak Hospital, Birmingham, UK 98 participants Inclusion criteria: distal radius fracture, treated by plaster cast immobilisation, living at home, age over 50 years, participants able to follow an exercise programme independently, informed consent. Exclusion criteria: medical history of dementia, Alzheimer's or psychiatric or confused state, multiple limb fractures or bilateral fracture, requiring physiotherapy for other reasons, pre‐existing inflammatory joint disorder. Past medical history of wrist problems or operations on affected side. Early manifestation of CRPS‐1 or carpal tunnel syndrome. Classification: AO and Frykman Sex: 82 female (84%) Age: median 69 years; range 50 to 92 years Assigned: 43/55 [physiotherapy/control] Assessed: 36/45 (at 4 weeks); 35/40 (at 12 weeks) | |
| Interventions | Timing of intervention: following plaster cast removal (5 to 6 weeks immobilisation). All participants given explanation of home care based on standardised advice and exercise sheet by physiotherapist 1. Referral for routine physiotherapy at outpatients clinic. Contents of treatment at discretion of physiotherapists; these involved different combinations of physiological mobilisation, progressive active exercise, passive stretching, accessory movements of wrist and radioulnar joints. Discharge criteria: functional ROM, full function, plateau of improvement 2. Home exercises alone | |
| Outcomes | Length of follow‐up: (median) 12 weeks; also (median) 4 weeks.
1. Functional: grip strength, ROM (pronation; supination; flexion; extension; radial deviation; ulnar deviation); functional analysis scale (Levine 1993), pain (VAS). Referral to occupational therapy 2. Number of contacts with physiotherapist; duration of physiotherapy, reasons for discharge 3. Complications: carpal tunnel syndrome & CRPS‐1 (mainly excluded from follow‐up) |
|
| Funding, ethics and patient consent | No mention of funding or ethics Informed patient consent | |
| Notes | Draft trial report received from Mrs Sarah Bache, now based in Australia, on 30 August 2001, and further details on 5 September. Further discussion on outcome measures on 12 September with feedback from trial statistician Louise Hiller | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomised" but statistician involved |
| Allocation concealment (selection bias) | Unclear risk | Draft report: "Consented patients were randomised individually by staff with sealed envelopes contained in a box". However, the trial investigator confirmed that there was "a possible chance of disclosure of assignment" |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Neither participants nor personnel providing care were blinded |
| Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Neither participants nor personnel providing care were blinded |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Abstract: "Blind assessment were performed at baseline (within one week of cast removal), and at four and 12 weeks" Draft report: "some patients discussed their treatment at review even though it was stated in the patient information sheet that this should not be done" |
| Blinding of outcome assessment (detection bias) Objective outcomes (functional impairment) | Unclear risk | As above |
| Blinding of outcome assessment (detection bias) Complications, number of sessions, return to former activity | Low risk | Outcomes unlikely to be affected by lack of blinding |
| Incomplete outcome data (attrition bias) Short term follow‐up (up to 3 months) | Unclear risk | There were 5 post‐randomisation exclusions and imbalance in the numbers lost to follow‐up (16% versus 27% at 12 weeks) |
| Incomplete outcome data (attrition bias) Longer term follow‐up | Unclear risk | No longer‐term follow‐up |
| Selective reporting (reporting bias) | Unclear risk | No protocol available. However, consistencies noted with draft report and trial registration document. Area under the curve analyses in response to detected baseline differences |
| Major baseline imbalance bias? | Unclear risk | Some trends towards patients randomised to physiotherapy and advice and exercise being more symptomatic at baseline. (Adjustments made in analyses) |
| Other performance bias (e.g. differential expertise bias) | Low risk | No problems detected None of the control group patients received physiotherapy or occupational therapy |