Plantar Heel Pain: Multisegment Foot Motion and Muscle Function, FFI Translation, and Evaluation of Treatments

NCT ID: NCT03161314

Last Updated: 2025-07-04

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-03-01

Brief Summary

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Plantar fasciitis (PF) is a prevalent musculoskeletal condition of plantar heel pain (PHP) that leads to pain, functional limitations, and reduced quality of life, especially among active adults aged 25 to 65. Understanding the biomechanical alterations in foot motion among individuals with PF is essential to inform targeted treatment strategies and prevent symptom chronicity. However, research exploring detailed multi-segment foot motion changes in this population remains limited.

Assessing foot function is a key component in understanding symptom development and treatment outcomes. The Foot Function Index (FFI) is an internationally recognized, reliable, and valid questionnaire used to measure foot pain and disability. To facilitate its use in Thai populations and enable cross-cultural comparisons, it is crucial to translate and validate the FFI into Thai.

Although exercise interventions such as strengthening and stretching are widely used to manage PHP, evidence regarding their relative effectiveness on pain reduction and gait improvement is inconclusive. Rigorous evaluation of these programs is needed to establish evidence-based guidelines for physical therapy in this population.

Study 1: Comparative Study of Gait and Foot Segment Motion Between Individuals with Plantar Fasciitis and Healthy Controls This study aimed to compare multi-segment foot motion during walking between individuals with plantar fasciitis (PF) and healthy controls. A matched case-control design was used, with gait data collected via a 3D motion capture system and analyzed using the Oxford Foot Model.

Study 2: Translation and Validation of the Thai Version of the Foot Function Index (FFI-Th) This study aimed to translate the Foot Function Index (FFI) into Thai (FFI-Th) and evaluate its psychometric properties individuals with plantar foot complaints.

Study 3: Effects of Strengthening and Stretching Exercise Programs on Pain and Gait in Patients with Plantar Fasciitis: A Randomized Controlled Trial This study aimed to investigate the effects of physical therapy interventions-specifically strengthening versus stretching exercise programs-on pain and temporospatial gait parameters in patients with PF.

Detailed Description

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Procedure

Study 1: Comparative Study of Gait and Foot Segment Motion Between Individuals with Plantar Fasciitis and Healthy Controls

A matched case-control study recruited individuals with PF and matched healthy controls by age, gender, weight, and height. After informed consent, anthropometric data were collected, and participants wore tight clothing to allow accurate marker placement. Forty-two reflective markers were attached to define foot and lower limb segments following the Oxford Foot Model and Plug-In-Gait protocols. A static calibration trial was recorded, after which some markers were removed. Then, participants performed walking trials along an 8-meter walkway while motion capture cameras and force plates recorded kinematic and kinetic data simultaneously. Each participant completed 3-5 gait trials at a self-selected comfortable speed, with two trials matching the control group's gait speed and cadence selected for analysis. Data were filtered and normalized over the gait cycle for further assessment. Outcome measures included ground reaction forces (GRFs) during braking and propulsion phases and peak multi-segment foot joint angles in three planes.

Study 2: Translation and Validation of the Thai Version of the Foot Function Index (FFI-Th)

This study used a cross-sectional design to translate and validate the Foot Function Index (FFI) into Thai (FFI-Th) following a standardized cross-cultural adaptation process. The steps included independent forward translation by two bilingual translators, synthesis by an expert committee, backward translation by two native English speakers, harmonization through consensus meetings, cognitive interviews with 20 individuals to ensure clarity, and final proofreading by a linguist. To assess criterion validity, participants also completed the EuroQol five-dimensional questionnaire (EQ-5D-5L) for health-related quality of life and a pain visual analogue scale (pain-VAS). These instruments provided comparative data for evaluating the FFI-Th's validity.

Study 3; Effects of Strengthening and Stretching Exercise Programs on Pain and Gait in individuals with Plantar Fasciitis: A Randomized Controlled Trial

This double-blind, randomized controlled trial was used. Individuals with PF were screened and recruited based on specific inclusion and exclusion criteria. After obtaining informed consent, participants were randomly assigned into two groups: strengthening exercises or stretching exercises. All participants received a standardized physical therapy treatment including therapeutic ultrasound and manual therapy, followed by their assigned exercise programs instructed by blinded physical therapists. Participants performed home-based exercises three times daily for 4 weeks, then continued at home for 2 months with exercise logs to monitor compliance. Outcome assessments were conducted five times: baseline, mid-intervention, post-intervention, and at 1- and 2-month follow-ups. Data collected included demographics, pain intensity via visual analogue scale (VAS), and temporospatial gait parameters measured by a force distribution platform and synchronized video system.

Conditions

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Plantar Fasciitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A stratified randomization table according to age (less or more than 50 years) and pain score (less or more than 5 out of 10 scores) was used.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Conservative physical therapy intervention was launched by the same physical therapist who blind to participant group allocation.

Study Groups

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Strengthening group

Individuals with PF who received strengthening exercises. (study 3)

Group Type EXPERIMENTAL

Strengthening exercises

Intervention Type PROCEDURE

Conservative physical therapy treatment with home-based strengthening exercises (study 3)

Stretching group

Individuals with PF who received stretching exercises. (study 3)

Group Type ACTIVE_COMPARATOR

Stretching exercises

Intervention Type PROCEDURE

Conservative physical therapy treatment with home-based stretching exercises (study 3)

Interventions

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Strengthening exercises

Conservative physical therapy treatment with home-based strengthening exercises (study 3)

Intervention Type PROCEDURE

Stretching exercises

Conservative physical therapy treatment with home-based stretching exercises (study 3)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Aged 20-80 years
* Plantar fasciitis (PF) symptoms for at least one month
* Pain or tenderness at the medial calcaneal tubercle or proximal plantar fascia
* At least one of the following symptoms:

* Morning pain (first steps in the morning)
* Pain after prolonged sitting
* Pain during weight-bearing activities


* No current or previous history of PF symptoms
* No foot pain


* Aged 20-80 years
* Experienced plantar foot pain or tenderness for at least one month (at rest or during weight-bearing activities)
* Able to read and communicate in Thai

* Aged 20-80 years
* Heel pain lasting more than one month
* Pain during the first steps in the morning or after rest
* Tenderness at the medial calcaneal tubercle
* Plantar fascia thickness greater than 4.0 mm (confirmed by ultrasound)

Exclusion Criteria

* Other painful conditions in the lower extremity or back
* History of rheumatoid arthritis
* Neurological or vascular diseases
* Leg length discrepancy \>1 cm
* Severe pain preventing walking


• Same as those listed for the PF group

* Pain in other areas of the lower extremities
* History of systemic inflammatory diseases
* History of neurological diseases
* Received any treatment during the study period


* History of back or lower limb surgery within 6 months
* Recent trauma or corticosteroid injections (within 6 months)
* Leg length discrepancy greater than 1 cm
* Pregnancy
* Inability to perform the exercise program
* Receiving other ongoing treatments or performing other foot-specific exercises
* Coexisting conditions including:

* Achilles tendinopathy
* Acute ankle sprain
* Tarsal tunnel syndrome
* Patellofemoral syndrome
* Calcaneal spurs
* Heel pad syndrome
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thailand Research Fund

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Sunee Bovonsunthonchai

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sunee Bovonsunthonchai, PhD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Motion analysis laboratory

Salaya, Nakhonpathom, Thailand

Site Status

Physical therapy center, Physical therapy faculty, Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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Martin RL, Davenport TE, Reischl SF, McPoil TG, Matheson JW, Wukich DK, McDonough CM; American Physical Therapy Association. Heel pain-plantar fasciitis: revision 2014. J Orthop Sports Phys Ther. 2014 Nov;44(11):A1-33. doi: 10.2519/jospt.2014.0303.

Reference Type BACKGROUND
PMID: 25361863 (View on PubMed)

Cole C, Seto C, Gazewood J. Plantar fasciitis: evidence-based review of diagnosis and therapy. Am Fam Physician. 2005 Dec 1;72(11):2237-42.

Reference Type BACKGROUND
PMID: 16342847 (View on PubMed)

Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003 May-Jun;93(3):234-7. doi: 10.7547/87507315-93-3-234.

Reference Type BACKGROUND
PMID: 12756315 (View on PubMed)

Chang R, Rodrigues PA, Van Emmerik RE, Hamill J. Multi-segment foot kinematics and ground reaction forces during gait of individuals with plantar fasciitis. J Biomech. 2014 Aug 22;47(11):2571-7. doi: 10.1016/j.jbiomech.2014.06.003. Epub 2014 Jun 11.

Reference Type BACKGROUND
PMID: 24992816 (View on PubMed)

Wearing SC, Smeathers JE, Yates B, Sullivan PM, Urry SR, Dubois P. Sagittal movement of the medial longitudinal arch is unchanged in plantar fasciitis. Med Sci Sports Exerc. 2004 Oct;36(10):1761-7. doi: 10.1249/01.mss.0000142297.10881.11.

Reference Type BACKGROUND
PMID: 15595298 (View on PubMed)

Budiman-Mak E, Conrad KJ, Mazza J, Stuck RM. A review of the foot function index and the foot function index - revised. J Foot Ankle Res. 2013 Feb 1;6(1):5. doi: 10.1186/1757-1146-6-5.

Reference Type BACKGROUND
PMID: 23369667 (View on PubMed)

Hill CL, Gill TK, Menz HB, Taylor AW. Prevalence and correlates of foot pain in a population-based study: the North West Adelaide health study. J Foot Ankle Res. 2008 Jul 28;1(1):2. doi: 10.1186/1757-1146-1-2.

Reference Type RESULT
PMID: 18822153 (View on PubMed)

Sullivan J, Burns J, Adams R, Pappas E, Crosbie J. Musculoskeletal and activity-related factors associated with plantar heel pain. Foot Ankle Int. 2015 Jan;36(1):37-45. doi: 10.1177/1071100714551021. Epub 2014 Sep 18.

Reference Type RESULT
PMID: 25237175 (View on PubMed)

Rathleff MS, Moelgaard C, Lykkegaard Olesen J. Intra- and interobserver reliability of quantitative ultrasound measurement of the plantar fascia. J Clin Ultrasound. 2011 Mar-Apr;39(3):128-34. doi: 10.1002/jcu.20787. Epub 2011 Jan 10.

Reference Type RESULT
PMID: 21387326 (View on PubMed)

Digiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, Baumhauer JF. Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis. A prospective clinical trial with two-year follow-up. J Bone Joint Surg Am. 2006 Aug;88(8):1775-81. doi: 10.2106/JBJS.E.01281.

Reference Type RESULT
PMID: 16882901 (View on PubMed)

Rathleff MS, Molgaard CM, Fredberg U, Kaalund S, Andersen KB, Jensen TT, Aaskov S, Olesen JL. High-load strength training improves outcome in patients with plantar fasciitis: A randomized controlled trial with 12-month follow-up. Scand J Med Sci Sports. 2015 Jun;25(3):e292-300. doi: 10.1111/sms.12313. Epub 2014 Aug 21.

Reference Type RESULT
PMID: 25145882 (View on PubMed)

Bovonsunthonchai S, Thong-On S, Vachalathiti R, Intiravoranont W, Suwannarat S, Smith R. Thai version of the foot function index: a cross-cultural adaptation with reliability and validity evaluation. BMC Sports Sci Med Rehabil. 2020 Sep 10;12:56. doi: 10.1186/s13102-020-00206-8. eCollection 2020.

Reference Type DERIVED
PMID: 32944253 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MU-CIRB 2016/182.0211

Identifier Type: -

Identifier Source: org_study_id

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