Plantar Fasciitis Management on Postural Control

Rehabilitation Clinical Trial

Official title:

Impact of Plantar Orthosis on Postural Control and Gait in Individuals With Plantar Fasciopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172517
• Other study ID #: 2020-404
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: April 28, 2025

Study information

• Verified date: May 2024
• Source: Université du Québec à Chicoutimi
• Contact: Rubens da Silva, PhD
• Phone: 4185455011
• Email: rubens.dasilva[@]uqac.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 28, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging Problems
• Foot Diseases
• Mobility Limitation
• Rehabilitation

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Canada	Rubens da Silva	Saguenay	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université du Québec à Chicoutimi

Country where clinical trial is conducted

Canada, 

References & Publications (13)

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. — View Citation

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. — View Citation

Chisholm MD, Birmingham TB, Brown J, Macdermid J, Chesworth BM. Reliability and validity of a weight-bearing measure of ankle dorsiflexion range of motion. Physiother Can. 2012 Fall;64(4):347-55. doi: 10.3138/ptc.2011-41. — View Citation

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. — View Citation

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/ — View Citation

Lauzier L, Kadri MA, Bouchard E, Bouchard K, Gaboury S, Gagnon JM, Girard MP, Larouche A, Robert R, Lapointe P, da Silva RA, Beaulieu LD. Vibration of the Whole Foot Soles Surface Using an Inexpensive Portable Device to Investigate Age-Related Alterations — View Citation

McClinton SM, Flynn TW, Heiderscheit BC, McPoil TG, Pinto D, Duffy PA, Bennett JD. Comparison of usual podiatric care and early physical therapy intervention for plantar heel pain: study protocol for a parallel-group randomized clinical trial. Trials. 201 — View Citation

Monteagudo M, de Albornoz PM, Gutierrez B, Tabuenca J, Alvarez I. Plantar fasciopathy: A current concepts review. EFORT Open Rev. 2018 Aug 29;3(8):485-493. doi: 10.1302/2058-5241.3.170080. eCollection 2018 Aug. — View Citation

Morrissey D, Cotchett M, Said J'Bari A, Prior T, Griffiths IB, Rathleff MS, Gulle H, Vicenzino B, Barton CJ. Management of plantar heel pain: a best practice guide informed by a systematic review, expert clinical reasoning and patient values. Br J Sports — View Citation

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. — View Citation

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, Avon). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21. — View Citation

Rene F, Casimiro L, Tremblay M, Brosseau L, Lefebvre A, Beaudouin M, Belliveau V, Bergeron LP. Une version canadienne francaise du Lower Extremity Functional Scale (LEFS) : L'Echelle fonctionnelle des membres inferieurs (EFMI), partie I. Physiother Can. 2 — View Citation

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 N — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural control measures	The participants will perform two 30-second trials on a strength platform (model BIOMEC400), the following tasks: without muscular vibration, with bilateral Achilles tendon vibration (Techno® concept VibrasensTM, France) in bipodal posture, and a balance task in semi-tandem posture with eyes open and closed. The vibration frequency chosen for the regions (sural triceps) will be 80 Hz. Center of Pressure (CoP) metrics will be used as main outcome such as sway CoP velocity variable (cm/s).	baseline,immediate only for experimental group), and after 8 weeks.
Primary	Gait measures	The participants will be asked to walk at normal, slow and fast speeds on a GaitRite treadmill (GAI-TRite® Platinum Plus System 16' - 4.876 m, SN: Q209, CIR Systems Inc., Franklin, NJ, USA). Participants will perform each task twice.Main gait parameters will be used as main outcomes such as velocity in m/s.	baseline,immediate only for experimental group), and after 8 weeks.
Secondary	Ankle mobility and foot position measure	Ankle mobility will be measured using the Weight-Bearing Lunge Test will be used to assess foot positioning.	baseline and after 8 weeks.
Secondary	Lower Extremity Functional measure	The Lower Extremity Functional Scale(LEFS) questionnaire will be used to measure participants' level of functionality in the lower limbs. The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. The columns on the scale are summed to get a total score. The maximum score is 80. he lower the score the greater the disability. The minimal detectable change is 9 scale points.	baseline and after 8 weeks.
Secondary	Pain measure by Foot function index	Foot Function Index will be used to measure foot pain and functionality. This index consists of 23 self-reported items divided into 3 subcategories: pain, disability and activity limitation. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.; The activity limitation subcategory consists of 5 items and measures limitations in activities because of foot problems, such as staying in bed all day. Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain. Both total and subcategory scores are calculated.	baseline and after 8 weeks.
Secondary	Pain duration	In addition to sef-reported pain intensity and duration in number of months will calculated.	baseline and after 8 weeks.