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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View full resultsBasic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2017-08-01
2019-03-01
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Strengthening group
Individuals with PF who received strengthening exercises. (study 3)
Strengthening exercises
Conservative physical therapy treatment with home-based strengthening exercises (study 3)
Stretching group
Individuals with PF who received stretching exercises. (study 3)
Stretching exercises
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)
Stretching exercises
Conservative physical therapy treatment with home-based stretching exercises (study 3)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
Yes
Sponsors
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Thailand Research Fund
OTHER
Mahidol University
OTHER
Responsible Party
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Sunee Bovonsunthonchai
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
Physical therapy center, Physical therapy faculty, Mahidol University
Bangkok, , Thailand
Countries
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MU-CIRB 2016/182.0211
Identifier Type: -
Identifier Source: org_study_id
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