None listed
Conditions
Brief summary
There are a number of studies that show that wearing an orthosis within a shoe helps resolution of heel pain. These orthoses often are prescribed to control excessive pronation, which is thought to be a mechanical factor contributing to overload and eventual pain of the tissues in the plantar heel region (also known as the planta fascia). Recently flip-flops have been designed with features similar to that of the orthoses, but without the need to be fitted within a shoe. A potential benefit of a flip-flop is that the high pain levels felt on first step in in the morning might be prevented if a flip-flop in the shape of an orthosis is worn. Wearing the flip-flop continually then might help relieve tissue stress of the plantar fascia and aid resolution of the problem. Interestingly, the material that flip-flops are made of might also be responsible for any pain relieving effect, hence the inclusion of a flat flip-flop as a comparator in this study. The aim of this study is to test if there are any differences between an in-shoe foot orthosis, a shaped flip-flop and a flat flip-flop over 12 weeks wear.
Interventions
Contoured flip-flops: these are based on the foot-bed of a prefabricated in-shoe foot orthosis, which are to be worn daily during waking hours for the 12 week study period.
Sponsors
Professor Bill Vicenzino
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
i. Report of (insidious non-traumatic onset) plantar heel pain for at least 1 month. ii. First step pain in the morning of at least a 3/10 on a Pain Numerical Rating Scale. iii. English communication skills to adequately understand questionnaires, allow valid treatment (orthoses) and outcome measurements to be performed iv. Adequate shoes into which the active comparator can be fitted v. Willingness to wear flip-flop or orthosis regularly for the 12 weeks duration of the trial
Exclusion criteria
i. History of previous therapy treatment of plantar fasciitis within the past month ii. History or diagnosis of circulatory conditions iii. Pregnancy iv. Foot pathologies (including diabetes, gout, amputation, nerve impingement, tarsal tunnel syndrome, tumours, stress fracture, autoimmune disease, pitting oedema, lower extremity referred pain, previous plantar fascia surgical procedures, corticosteroid injections) within the past 12 months (for the transient conditions or treatments) v. Participation in athletic activity 5 or more days per week for more than 90 minutes for day vi. Other orthopaedic or neurological impairment that prevents a symmetrical walking pattern or an antalgic gait that was not attributed to plantar heel pain
Outcome results
None listed