Trial reportBMC musculoskeletal disorders2016
Flip-flop footwear with a moulded foot-bed for the treatment of foot pain: a randomised controlled trial.
Trial report in BMC musculoskeletal disorders, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Study Into the Use of Prefabricated Orthotics in Shoes, in Combination With Using Indoor Comfort Sandals With built-in Arch Support vs. the Sole Use of Prefabricated Orthotics in Shoes Alone, for the Treatment of Plantar Fasciitis. A Randomised Control Trial
Evaluation of the Efficacy of Corrective Rubber Insoles in a Population of Healthcare Professionals With Foot Overpronation
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.
- The effects of shoe type on lower limb venous status during gait or exercise: A systematic review.PloS one · 2020Pooled it
- Use of orthotics with orthotic sandals versus the sole use of orthotics for plantar fasciitis: Randomised controlled trial.World journal of orthopedics · 2023Trial
- Effectiveness of Sandals Combined with Physical Therapy Versus Physical Therapy Alone on Pain and Function in Plantar Fasciitis: A Randomised Controlled Trial.The Malaysian journal of medical sciences : MJMS · 2025Article
- Article
- Effects of insoles adapted in flip-flop sandals for persistent heel pain: a protocol for a sham-controlled randomised trial.BMJ open · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFoot pain is a common problem affecting up to 1 in 5 adults and is known to adversely affect activities of daily living and health related quality of life. Orthopaedic footwear interventions are used as a conservative treatment for foot pain, although adherence is known to be low, in part due to the perception of poor comfort and unattractiveness of the footwear. The objective of this trial was to assess the efficacy of flip-flop style footwear (Foot Bio-Tec©) with a moulded foot-bed in reducing foot pain compared to participant's usual footwear.
methodsTwo-arm parallel randomised controlled trial using computer generated random allocation schedule at an Australian university podiatry clinic. 108 volunteers with disabling foot pain were enrolled after responding to an advertisement and eligibility screening. Participants were randomly allocated to receive footwear education and moulded flip-flop footwear to wear as much as they were comfortable with for the next 12 weeks (n = 54) or footwear education and instructions to wear their normal footwear for the next 12 weeks (n = 54). Primary outcome was the pain domain of the Foot Health Status Questionnaire (FHSQ). Secondary outcomes were the foot function and general foot health domains of the FHSQ, a visual analogue scale (VAS) for foot pain and perceived comfort of the intervention footwear.
resultsCompared to the control group, the moulded flip-flop group showed a significant improvement in the primary outcome measure of the FHSQ pain domain (adjusted mean difference 8.36 points, 95 % CI 5.58 to 13.27, p < 0.01). Statistical and clinically significant differences were observed for the secondary measure of foot pain assessed by a VAS and the FSHQ domains of foot function and general foot health. None of the participants reported any pain or discomfort from the intervention footwear and six (footwear group = 4) were lost to follow up.
conclusionsOur results demonstrate that flip-flop footwear with a moulded foot-bed can have a significant effect on foot pain, function and foot health and might be a valuable adjunct therapy for people with foot pain.
trial registrationACTRN12614000933651 . Retrospectively registered: 01/09/2014.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.