Evidence map›Paper›PMID 35964021›Full record

Trial reportBMC musculoskeletal disorders2022

Effectiveness of mechanical treatment with customized insole and minimalist flexible footwear for women with calcaneal spur: randomized controlled trial.

Ana Paula Ribeiro, Brenda Luciano de Souza, Silvia Maria Amado João

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2022. 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.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT03040557 nacompletednot on this map

Therapeutic Effect of Minimalist Flexible Footwear and Insoles on Clinical, Functional and Biomechanical Aspects of the Individuals With Plantar Fasciitis and Calcaneus Spur

TypeinterventionalSponsorUniversity of Sao PauloRan2017 to 2019Enrolled65ConditionsPlantar Fasciitis of Right Foot (Disorder), Heel SpurArmsFlexible footwear, Orthopedic insole
NCT05885243 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Evaluation of the Efficiency of ESWT and Custom İnsoles Produced With Podometric Measurement in the Treatment of Painful Heel Spurs

TypeinterventionalSponsorBezmialem Vakif UniversityRan2023 to 2023Enrolled48ConditionsHeel Spur, Heel Spur Syndrome, Heel Pain SyndromeArmsESWT, customized insoles, combined ESWT and custtomized insoles
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Ana Paula RibeiroPhysical Therapy Department, Post-Graduate Department, School of Medicine, University of São Paulo, R: Cipotânea, 51, Campus Universitário, São Paulo/SP, Brazil. apribeiro@alumni.usp.br.
Brenda Luciano de SouzaSchool of Medicine, Post-Graduate in Health Science Department, Biomechanics and Musculoskeletal Rehabilitation Laboratory, University Santo Amaro, São Paulo, Brazil.
Silvia Maria Amado JoãoPhysical Therapy Department, Post-Graduate Department, School of Medicine, University of São Paulo, R: Cipotânea, 51, Campus Universitário, São Paulo/SP, Brazil.
Universidade de São Paulo · BRUniversidade de Santo Amaro · BR

Funding

National Council for Scientific and Technological Development (CNPq), Ministry of Science, Technology, Innovations and Communications of the Brazil 458700/2014
6 · The paper itself

Abstract

backroundCalcaneal spurs are described as bony outgrowths arising on medial calcaneal, where inappropriate footwear can promote disease progression.

objectiveInvestigate the effectiveness of mechanical treatment with customized insole and minimalist flexible footwear during gait training program in women with calcaneal spur.

methodsDesign: A single-blinded, randomized and controlled trial.

settingBiomechanics laboratory.

participantsForty-three women, 29 with calcaneal spur and 14 control.

interventionGait training program with use of the minimalist flexible footwear (MFG n = 15, age: 48.9 ± 9.4, height: 1.61 ± 0.1, BMI: 32.1 ± 7.0) and customized insole on footwear (COIG n = 14, age: 50.3 ± 5.8, height: 1.62 ± 0.1, BMI: 32.2 ± 4.3) and control (CG n = 14, age: 47.8 ± 8.6, height: 1.63 ± 0.1, BMI: 27.5 ± 4.5), followed of the evaluations: baseline (T0) and after three (T3) and six (T6) months. Duration of the intervention was of the six months consecutive for at least 42 h per week (six hours a day, seven days a week). Outcome primary were calcaneus pain (visual analogue scale), Foot Function Index (FFI), Foot Health Status Questionnaire (FHSQ-Br) and 6-min walk test (6MWT). Secondary was plantar pressure distribution by a pressure platform system during gait and static index foot posture (FPI). STATISTICAL ANALYSIS: analysis of variance for repeated measure and between groups were used to detect treatment-time interactions (α = 5%). Effect size with D Cohen's also was used between T0 and after six (T6) months of intervention.

resultsThe MFG and COIG were effective at reducing pain after six months (MFG: 2.5-4.5 CI, p = 0.001; COIG: 1.5-3.5 CI, p = 0.011). The FFI and FHSQ-Br showed improvements with MFG and COIG after T6 (MFG: 13.7-15.4 CI, p = 0.010; COIG: 11.3-15.0 CI, p = 0.001). The 6MWT increased with MFG (589.3-622.7 CI) and COIG (401.3-644.7 CI) and foot pronation was decreased after T3 and T6 MFG (FPI Right: 4.2-5.4 CI; Left: 3.6-5.4 CI) COIG (FPI Right: 3.4-6.8 CI; Left: 3.3-5.7 CI). The contact area reduced on forefoot and rearfoot with MFG and GOIG and midfoot and rearfoot with MFG. Maximum force was reduced on foot with MFG after T3 and T6. The peak pressure was reduced on the forefoot with MFG and COIG and on midfoot and rearfoot with MFG.

conclusionsThe mechanical treatment with customized insole and minimalist flexible footwear during gait training program during six months in women with calcaneal spur reduced the calcaneus pain, increased function and health feet and reduced plantar load on the rearfoot, midfoot and forefoot. However, the footwear alone was more effective than when combined customized insole, given the greater efficacy on clinical and biomechanical aspects.

trial registrationClinicalTrials.gov NCT03040557 (date of first registration: 02/02/2017).

Indexed as

Heel SpurAdultFemaleFootGaitHumansMiddle AgedPainShoesCalcaneus spurFootFootwearGaitInsolesPainTraining

Identifiers

PMID35964021
PMCPMC9375309
OpenAlexW4291116358

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.