Optimising physiotherapy for people with lateral elbow tendinopathy - Results of a mixed-methods pilot and feasibility randomised controlled trial (OPTimisE).
M Bateman, A Skeggs, E Whitby and 11 others
PMID 38194841WHAT IT FOUND
Both groups improved over six months with no clear advantage for the structured intervention.
The authors question whether a future head-to-head trial is warranted and propose comparing diagnosis, reassurance and self-help advice against usual care.
Key findings
01All four pre-specified feasibility criteria (consent rate, intervention fidelity, attendance rate, and 6-month outcome completion) met their thresholds, supporting the possibility of a future trial.
02Descriptive data showed both groups improving in pain, function and perceived treatment effect over six months, and in some outcomes the trend favoured the usual care group rather than the structured intervention.
03The authors state that a future trial using the same intervention approach is unlikely to be desirable, and propose instead comparing a single appointment of diagnosis, reassurance and self-help advice against usual physiotherapy.
STILL TO COME
How it was doneWhat they foundWhat it means for PTs
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What it does not show
The study was not powered for between-group comparison, so the descriptive outcome data cannot be used to conclude that either treatment is better. Neither participants nor physiotherapists were blinded, and data analysis was not masked to allocation. Usual care was not standardised; physiotherapists had no restrictions on what they could offer, so the control group is a moving target. Questionnaire returns were low at 6 weeks (59%) and 12 weeks (65%), and the 6-month rate of 81% was only achieved after a protocol amendment allowing telephone data collection. Five participants in the OPTimisE group never attended their first session and received no intervention, yet were included in the analysis. The authors note that usual care at research-active sites may be of higher quality than in general practice, which could inflate the control group's results. No translation services were provided, potentially excluding under-served communities. Only 6 of 18 OPTimisE participants returned exercise diaries, limiting adherence data.
Declared interests
Funded by the NIHR and the Chartered Society of Physiotherapy Charitable Trust. The lead author holds a doctoral fellowship from the same two bodies. The authors declare no conflicts of interest.
The easy way to misread this
Do not read the descriptive outcome data as evidence that the OPTimisE protocol outperforms usual physiotherapy. The study was not powered for between-group comparison, and in some measures the trend actually favoured the usual care group. The authors themselves question whether a future head-to-head trial is warranted.
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