Plantar Fasciitis Management on Postural Control

NCT ID: NCT06172517

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-08

Study Completion Date

2024-12-28

Brief Summary

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Foot pain is common in the general population. Plantar fasciopathy may affect 7% of the population at some time in their lives, but the incidence increases with age. This plantar problem is characterized by severe pain under the foot (at plantar level), which can be very incapacitating and disabling. This can lead to absenteeism from work, particularly for employees working in a standing posture. Various therapeutic avenues can be used to reduce pain and improve functionality, such as physiotherapy, infiltrations and surgery. In this research project, the propose the use of a conservative approach through the use of foot orthoses, which appears to be effective in reducing pain. The aim of the study is thus to better understand the effect of foot orthoses on postural balance and walking in workers with plantar fasciopathy. Participants will be assessed at baseline and eight weeks later to observe measured changes and clinical improvements following orthotic wear. Balance and gait pattern will be assessed using technological tools that have been validated in this respect. Participants will also be asked about their pain intensity. The hypothesis is that wearing the orthosis will improve the participants' balance and walking abilities, as well as reduce the level or intensity of their pain. In addition, this study could have an impact on the rate of absenteeism from work from current context of labour shortages.

Detailed Description

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Plantar fasciopathy is a musculoskeletal disorder, known as a degeneration of the plantar fascia associated with a sensation of pain at plantar level. This disorder, for which around 2 million people a year receive treatment, has a prevalence of 3.6% to 7%, affecting both men and women between the ages of 45 and 64, and increasing with age. People aged between 25 and 65, who make up the majority of the working population, present 83% of plantar fasciopathy cases. According to CNESST statistics for 2022, 15,310 files opened concerned musculoskeletal disorders of the lower limb, 2133 of which involved the feet. There is also evidence of a possible cause-effect relationship between the number of hours spent standing or walking and the risk of developing plantar fasciopathy, which is indeed a major risk factor for many active workers. People with plantar fasciopathy will be absent from work more regularly, contributing to lower productivity at work. In addition to reduced work productivity, the cost of treatment has been estimated at US$584 million in the United States alone. In addition to pain, other deficits can be observed in people with plantar fasciopathy. A recent study also demonstrated its impact from a biomechanical point of view, notably on postural balance and gait in young adults suffering from this health problem. A number of treatments are currently used to treat this clinical foot condition, both conservatively and surgically. Among the most widely used conservative treatments, foot orthoses have been shown to be effective in reducing pain, despite the paucity of studies on the issue. Some studies have also demonstrated its effects on balance measures. Or, balance afferents originate from the somatosensory system, and tendon vibration can disrupt this system. However, few studies have measured its effects on postural control reactions via tendon vibration following orthotic use and in an ageing population, and no study has specifically investigated the effect of plantar orthoses in cases of plantar fasciopathy on gait pattern parameters in ageing workers.

Conditions

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Rehabilitation Aging Problems Foot Diseases Mobility Limitation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Clinical intervention by orthoses
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Othesis intervention

This group with custom-made foot orthotics prescribed by podiatrists (foot impression, polypropylene orthotics and covering at podiatrists' discretion).

Group Type EXPERIMENTAL

Orthosis intervention

Intervention Type OTHER

Clinical feasibility trial with one group using a custom-made foot orthotics prescribed by podiatrists (foot impression, polypropylene orthotics and covering at podiatrists' discretion).

Control group

Without orthesis prescriptions by podiatrists.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Orthosis intervention

Clinical feasibility trial with one group using a custom-made foot orthotics prescribed by podiatrists (foot impression, polypropylene orthotics and covering at podiatrists' discretion).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Present a history of pain under the heels for more than 3 months
* Have a diagnosis of plantar fasciopathy
* Pain of at least 3/10 under the heel
* Have post-static dyskinesia
* To be in the job market (adults between 20 and 65 years)

Exclusion Criteria

* Severe systemic diseases
* Red flags (e.g. tumors),
* Musculoskeletal deformities affecting the lower limbs
* Musculoskeletal surgery
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université du Québec à Chicoutimi

OTHER

Sponsor Role lead

Responsible Party

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Rubens da Silva

Director and professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rubens da Silva, PhD

Role: STUDY_DIRECTOR

Université du Québec à Chicoutimi

Locations

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Rubens da Silva

Saguenay, Quebec, Canada

Site Status

Countries

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Canada

References

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Duncan JR, Potter CB, Cappellini MD, Kurtz JB, Anderson MJ, Weatherall DJ. Aplastic crisis due to parvovirus infection in pyruvate kinase deficiency. Lancet. 1983 Jul 2;2(8340):14-6. doi: 10.1016/s0140-6736(83)90005-3.

Reference Type BACKGROUND
PMID: 6134886 (View on PubMed)

Beeson P. Plantar fasciopathy: revisiting the risk factors. Foot Ankle Surg. 2014 Sep;20(3):160-5. doi: 10.1016/j.fas.2014.03.003. Epub 2014 Mar 22.

Reference Type BACKGROUND
PMID: 25103701 (View on PubMed)

Ichioka T, Tashiro T, Hara T, Ichioka E. [Trial testing of the auto-refractometer NIDEK AR-3000 for mass examination of children and kindergarten, primary, junior high, and high school students]. Josai Shika Daigaku Kiyo. 1985;14(1):139-47. No abstract available. Japanese.

Reference Type BACKGROUND
PMID: 3866618 (View on PubMed)

Richer L, Fortin E, Gagnon G, Ngomo S, Fernandes KBP, Cortis C, Sobczak S, da Silva RA. Impact of plantar fasciitis on postural control and walking in young middle-aged adults. Foot (Edinb). 2022 Dec;53:101951. doi: 10.1016/j.foot.2022.101951. Epub 2022 Nov 4.

Reference Type BACKGROUND
PMID: 36463613 (View on PubMed)

Crawford F, Thomson CE. WITHDRAWN. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000416. doi: 10.1002/14651858.CD000416.pub2.

Reference Type BACKGROUND
PMID: 20091508 (View on PubMed)

Goguel V, Rosbash M. Splice site choice and splicing efficiency are positively influenced by pre-mRNA intramolecular base pairing in yeast. Cell. 1993 Mar 26;72(6):893-901. doi: 10.1016/0092-8674(93)90578-e.

Reference Type BACKGROUND
PMID: 8458083 (View on PubMed)

Anderson J, Stanek J. Effect of foot orthoses as treatment for plantar fasciitis or heel pain. J Sport Rehabil. 2013 May;22(2):130-6. doi: 10.1123/jsr.22.2.130. Epub 2012 Oct 2.

Reference Type BACKGROUND
PMID: 23037146 (View on PubMed)

Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clin Biomech (Bristol). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21.

Reference Type BACKGROUND
PMID: 16182419 (View on PubMed)

House WF, Hitselberger WE, Horn KL. The middle fossa transpetrous approach to the anterior-superior cerebellopontine angle. Am J Otol. 1986 Jan;7(1):1-4.

Reference Type BACKGROUND
PMID: 3484905 (View on PubMed)

Mok J. HIV infection in children. J R Coll Gen Pract. 1988 Aug;38(313):342-4. No abstract available.

Reference Type BACKGROUND
PMID: 3076903 (View on PubMed)

Pourtier-Piotte C, Pereira B, Soubrier M, Thomas E, Gerbaud L, Coudeyre E. French validation of the Foot Function Index (FFI). Ann Phys Rehabil Med. 2015 Oct;58(5):276-82. doi: 10.1016/j.rehab.2015.07.003. Epub 2015 Sep 4.

Reference Type BACKGROUND
PMID: 26343763 (View on PubMed)

Kadri MA, Chevalier G, Mecheri H, Ngomo S, Lavalliere M, da Silva RA, Beaulieu LD. Time course and variability of tendinous vibration-induced postural reactions in forward and backward directions. J Electromyogr Kinesiol. 2020 Apr;51:102386. doi: 10.1016/j.jelekin.2020.102386. Epub 2020 Jan 20.

Reference Type BACKGROUND
PMID: 32014802 (View on PubMed)

Hayashi K, Hirata Y, Kurushima H, Saeki M, Amioka H, Nomura S, Kuga Y, Ohkura Y, Ohtani H, Kajiyama G. Effect of dietary hydrogenated corn oil (trans-octadecenoate rich oil) on plasma and hepatic cholesterol metabolism in the hamster. Atherosclerosis. 1993 Feb;99(1):97-106. doi: 10.1016/0021-9150(93)90055-y.

Reference Type BACKGROUND
PMID: 8461065 (View on PubMed)

Other Identifiers

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2020-404

Identifier Type: -

Identifier Source: org_study_id

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