NCT03161314

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

July 4, 2025

Completed
Last Updated

July 4, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

May 8, 2017

Results QC Date

May 26, 2025

Last Update Submit

June 13, 2025

Conditions

Keywords

plantar fasciitismultisegment foot motiongaitphysical therapystrengtheningstretchingexercisetranslationplantar heel pain

Outcome Measures

Primary Outcomes (2)

  • Worst Pain

    Worst pain was assessed using the Visual analog scale (VAS), where 0 indicates "no pain" and 10 indicates "pain as bad as participants can imagine". Participants were asked to report their worst pain level over the past 24 hours. Higher scores indicate more severe pain. Unit of Measure: scores

    Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

  • Morning Pain

    Morning pain intensity upon waking was assessed using a 10 cm Visual Analog Scale (VAS), where participants mark a point along a continuous line anchored by "no pain" (0) and "worst imaginable pain" (10), with higher values indicating more severe morning pain. Unit of Measure: scores

    Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

Secondary Outcomes (4)

  • Cadence

    Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

  • Stride Length

    Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

  • Stride Time

    Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

  • Gait Speed

    Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

Study Arms (2)

Strengthening group

EXPERIMENTAL

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

Procedure: Strengthening exercises

Stretching group

ACTIVE COMPARATOR

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

Procedure: Stretching exercises

Interventions

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

Strengthening group

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

Stretching group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • No current or previous history of PF symptoms
  • No foot pain
  • Same as those listed for the PF group
  • 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
  • Pain in other areas of the lower extremities
  • History of systemic inflammatory diseases
  • History of neurological diseases
  • Received any treatment during the study period
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Motion analysis laboratory

Salaya, Nakhonpathom, Thailand

Location

Physical therapy center, Physical therapy faculty, Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (12)

  • 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.

    PMID: 25361863BACKGROUND
  • 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.

    PMID: 16342847BACKGROUND
  • 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.

    PMID: 12756315BACKGROUND
  • 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.

    PMID: 24992816BACKGROUND
  • 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.

    PMID: 15595298BACKGROUND
  • 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.

    PMID: 23369667BACKGROUND
  • 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.

MeSH Terms

Conditions

Fasciitis, PlantarMotor Activity

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

This study did not compare to the pure conservative physical therapy treatment, which may provide more information about the effectiveness of strengthening and stretching exercises that may superior to the conservative treatment alone.

Results Point of Contact

Title
Asst.Prof.Dr. Sunee Bovonsunthonchai
Organization
Physical Therapy Faculty, Mahidol University

Study Officials

  • Sunee Bovonsunthonchai, PhD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Conservative physical therapy intervention was launched by the same physical therapist who blind to participant group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 19, 2017

Study Start

August 1, 2017

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

July 4, 2025

Results First Posted

July 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations