REF-1643 · Bonanno et al., 2017 · British Journal of Sports Medicine, Vol. · Paper · PubMed

Foot orthoses lowered injury in prevention trials (any injury RR 0.72, 95% CI 0.55 to 0.94; stress fractures RR 0.59, 0.45 to 0.76) but not soft-tissue injury (RR 0.79, 0.55 to 1.14), and shock-absorbing insoles lowered none of the three

A meta-analysis of 11 orthosis and 7 insole trials whose quality varied widely (median PEDro 5/10 and 3/10)

Main caveat: Who was studied, how many people, which orthoses and for how long are not in the abstract; transfer to runners is not established.
fairly strong evidenceMeasured on a mixed groupRead from the abstract only

Bonanno and colleagues asked whether foot orthoses, and separately shock-absorbing insoles, prevent musculoskeletal injury. They searched five databases from their start to early June 2016 for clinical trials testing either device for prevention and pooled the results as risk ratios. Eleven orthosis trials and seven insole trials qualified.

Trial quality on the PEDro scale was middling for the orthoses (median 5 of 10, range 3-8) and low for the insoles (median 3, range 1-7). Orthoses went with fewer injuries of any kind (RR 0.72, 95% CI 0.55 to 0.94) and fewer stress fractures (RR 0.59, 0.45 to 0.76); the drop in soft-tissue injury was not significant (RR 0.79, 0.55 to 1.14).

Shock-absorbing insoles changed neither overall injury (RR 0.92, 0.73 to 1.16), stress fractures (RR 1.15, 0.57 to 2.32) nor soft-tissue injury (RR 0.92, 0.74 to 1.15).

The authors conclude that orthoses lower the risk of injury overall and of stress fractures, though not of soft-tissue injury, that insoles prevented nothing, and that better-designed trials are needed because the included trials differed so much in quality.

Participants

Not in the abstract: the number of participants, their sport or setting, age, sex and training level.
The PubMed record indexes the review under athletic injuries, stress fractures and soft-tissue injuries, with randomised controlled trials as topic.

Methods

Search: Cochrane Library, CINAHL, EMBASE, MEDLINE and SPORTDiscus, from inception to the first week of June 2016.
Inclusion: clinical trials evaluating foot orthoses or shock-absorbing insoles for the prevention of injury.
Studies: 11 orthosis trials, 7 insole trials.
Quality: PEDro scale; median 5/10 (range 3-8) for the orthosis trials, 3/10 (range 1-7) for the insole trials.
Pooling: risk ratios with 95% confidence intervals for any injury, stress fractures and soft-tissue injuries.
Not in the abstract: whether every trial was randomised, the orthosis types (custom or prefabricated), wear time, follow-up, the pooling model and heterogeneity.

Key Results

Outcome (RR < 1 favours the device)Foot orthoses (11 trials in the review)Shock-absorbing insoles (7 trials)
Any injury0.72 (0.55 to 0.94)0.92 (0.73 to 1.16)
Stress fracture0.59 (0.45 to 0.76)1.15 (0.57 to 2.32)
Soft-tissue injury0.79 (0.55 to 1.14), not significant0.92 (0.74 to 1.15)
The number of trials pooled for each outcome is not in the abstract.
Quality: orthosis trials median PEDro 5/10, insole trials 3/10.

Practical Application

An orthosis showed a preventive signal, mainly for stress fractures; a cushioned insole showed none. Across prevention trials, foot orthoses went with fewer injuries overall (RR 0.72) and fewer stress fractures (RR 0.59), while shock-absorbing insoles changed no outcome. The review does not support buying shock-absorbing insoles to prevent injury.
Soft-tissue injuries were not clearly prevented by either device (orthoses RR 0.79, 0.55 to 1.14, not significant; insoles RR 0.92).
Inference, not tested here: if, as in the base's other orthosis review (REF-1386), many of these trials were in military recruits with a high stress-fracture rate, a recreational runner's absolute benefit would be smaller than the relative figures suggest.
Who decides: whether a particular runner needs an orthosis, and which one, is for a podiatrist or sports physician; bone-like pain goes to a clinician, not to an insole (SYNTH-94). The assistant does not diagnose.
Not settled by this design / not from this paper: which orthosis type works, custom against prefabricated, whether the effect holds in runners specifically, what happens when a habitual user runs without them, and treatment of an existing pain.

Limitations

Who was studied, how many people, which orthoses and for how long are not in the abstract; transfer to runners is not established.
Trial quality was middling to low (PEDro medians 5 and 3 of 10); the insole results rest on the weaker trials.
Heterogeneity and the pooling model are not in the abstract.
The search ends in June 2016; later trials are not included.
"Soft-tissue injury" is a broad category; specific diagnoses are not in the abstract.
Written from the abstract and the PubMed record; full text not read.
How this entry was checked and changed
Why this level

a meta-analysis of prevention trials whose abstract reports its quality assessment and what it found (median PEDro 5/10, range 3-8, for the orthosis trials; 3/10, range 1-7, for the insole trials; the authors say quality "varied greatly"), so A- at most under rule 1; participant numbers, populations and heterogeneity are not in the abstract

Content correction 2026-11-07
2026-11-07: added from the abstract and the PubMed record; level A- (meta-analysis of prevention trials; PEDro quality reported in the abstract, middling for the orthosis trials and low for the insole trials).