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OpenTrials
Completed

NCT Number: NCT01145118

Reliability of Functional Outcome Measures in Plantar Fascitis Patients

Plantar Fasciitis (PF) is the most common foot condition treated by healthcare providers, striking approximately 2 million Americans each year. Nevertheless its causes are still not known. The risk factors for PF are known and the diagnosis, which is based on clinical assessment, is relatively simple. Still most of the treatments for PF focus on short term symptoms relief instead of prevention or reduction of recurrence.

Physical therapy treatment that focuses on reducing the symptoms for the long run and prevention, should include outcome measures, which if found to be reliable, will make the diagnosis clearer. Diagnosis based on reliable clinical and functional measures will assist the physical therapist to understand the major deficiencies of the patient, and accordingly to help him to make the right decision in choosing treatment. Also comprehensive knowledge of the characteristics of PF may enable selection of appropriate preventive measures.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clalit Health Services, Haifa and Western Galilee District

Haifa, Israel

About this study

Objectives:

Characterize the unilateral PF syndrome using functional outcome measures, while comparing them to the healthy foot of the same patient. In addition the study will investigate the reliability of these functional outcome measures in PF patients.

Methodology:

Individuals referred to physiotherapy for PF will be assessed for eligibility and consent for the study. They will undergo two evaluations on the same week to evaluate the test- retest reliability of the functional measurements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral plantar fasciitis
  • Painful first step in the morning
  • Calcaneal soreness in palpation
  • Insured by Clalit Health Care Services
  • Signed informed consent

Exclusion criteria

  • Ankle or foot surgery
  • Congenital deformation of foot
  • Lower limb spasticity
  • Using assistive devices
  • Bilateral plantar fasciitis
  • Refuse to participate or sign informed consent

Treatment and study plan

Primary outcomes

  1. Functional Limitation

    Time frame: 1 week

    Measurement of Functional Limitation using Foot Function Index (FFI) compared to the healthy foot

Secondary outcomes

  1. Pain intensity

    Time frame: 1 week

    Measurement of pain intensity using visual analog scale (VAS), compared to the healthy foot

  2. Pain threshold

    Time frame: 1 week

    Measurement of pain threshold using a Pressure Algometer, compared to the healthy foot

  3. Muscle strength

    Time frame: 1 week

    Measurement of Muscle strength in Plantar Flexion and Dorsi Flexion using Hand Held Dinamometer - compared to the healthy foot.

  4. Range of motion

    Time frame: 1 week

    Measurement of Range of motion using a Digital inclinometer - compared to the healthy foot

Sponsors and collaborators

Lead sponsor

Clalit Health Services

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 16, 2010
Registry last updated
Jan 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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