Van Lelieveld 1979.
| Methods | Randomised clinical trial (computer generated random numbers). Blinding of patients and outcome assessment. No blinding of care provider. | |
| Participants | Haslev, Denmark. All patients with acute ankle distortions referred to the X‐ray department (n = 60). Inclusion criteria: time since injury 0‐4 days, first distortion ever. 42% men, 58% women, mean age 23 to 29 years | |
| Interventions | Group 1: continuous ultrasound: 0.5 W/cm², 5 to 10 minutes, 5x/week, 2 weeks (n = 20?). Group 2: electrotherapy: diadynamic current, pulse duration 10 msec, 50/100 Hz, 4‐8 minutes (n = 20?). Group 3: sham ultrasound (n = 20?). Co‐interventions: elastic bandages, crutches, leg elevation, plantar flexion exercises. | |
| Outcomes | Length of follow‐up: 15 days.
At baseline, and daily until maximum of 15 days:
‐ % patients with swelling < 0.5 cm at 7 days
‐ % patients able to walk at 7 days
‐ % patients pain free at 7 days ‐ swelling (joint circumference in cm), means, no SD ‐ range of motion (1 = 20°, 2 = 40°, 3 = > 40° restriction), means, no SD ‐ pain (6‐point scale), means, no SD Dropouts: 3 (2 did not complete treatment; 1 incorrect diagnosis), distribution was not reported Adverse reactions: not described |
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| Notes | Authors' conclusions: ultrasound therapy has no significant effect on the course of recovery. The assumption in the analyses of allocation of 20 patients to each group seems to be supported in the graphical representations. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random plan devised before the trial |
| Allocation concealment (selection bias) | Unclear risk | No description in trial report |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Acceptable drop‐out rate but the distribution was not reported. |
| Baseline similarity | Unclear risk | No complete information on prognostic factors or baseline values of outcome measures |
| Blinding of care provider | High risk | Physician not blinded |
| Control for co‐interventions | Low risk | Similar advice to all participants |
| Adherence to treatment | Unclear risk | No information in trial report |
| Blinding of patients | Low risk | Sham ultrasound |
| Blinding of outcome assessment | Low risk | Outcome assessment by blinded observers |
| Timing of outcome assessment | Low risk | Similar timing |