Sun 2014.
Methods | Randomised controlled trial, blinded, parallel group. Follow‐up of 6 months, at baseline, 2 weeks, 1 month, 3 months and 6 months. | |
Participants | 75 participants, unilateral ankle pain for at least 6 months; Age between 20 and 85. 37 Hyalgan group (mean age 50.6 (SD 10.3), 14 female, 23 male) and 38 in Botuline group (mean age 49.5 (SD 10.9), 15 female, 23 male) At baseline a AOS score of > 30 and < 90 was mandatory. Ankle OA based on an X ray within 6 months of baseline and equivalent with Kellgren Lawrence grade II | |
Interventions | Single injection of 2 ml Hyalgan intra‐articular versus Botuline, combined with 12 session (3 weekly for 4 weeks of physical therapy (PT)). | |
Outcomes | Primary outcome total AOS. Pain (AOS, AOFAS, VAS, Rescue Medication), Safety (registering amount of adverse events), Physical function (AOS, AOFAS, Single Leg stance test (SLS), Timed up and go Test (TUG)), analgesic consumption, satisfaction. | |
Notes | Two totally different injections are compared, and one group even had a physical therapy program added. Unclear why they compared these two treatments, as it made more sense to compare without physical therapy. The study was supported by a grant of VGHKS100‐061 (an academic research fund from the hospital's medical research council). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation: groups of 4. |
Allocation concealment (selection bias) | Low risk | Block randomisation: groups of 4. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Injection compared to injection followed by PT makes it likely that the participants communicated which treatment they underwent. Impossible to blind participants to the therapy they underwent. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The secondary outcomes like SLS might be affected by knowing which therapy the participant underwent. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. |
Selective reporting (reporting bias) | Low risk | Results show same outcomes as described in the Method section. |
Other bias | Unclear risk | Unclear what the effect is of two completely different treatment options where one injection + exercise therapy is compared to another injection. |