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.

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Clalit Health Services, Haifa and Western Galilee District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Individuals referred to community physiotherapy center for plantar Fasceitis treatment.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Limitation	Measurement of Functional Limitation using Foot Function Index (FFI) compared to the healthy foot	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Measurement of pain intensity using visual analog scale (VAS), compared to the healthy foot	1 week
Pain threshold	Measurement of pain threshold using a Pressure Algometer, compared to the healthy foot	1 week
Muscle strength	Measurement of Muscle strength in Plantar Flexion and Dorsi Flexion using Hand Held Dinamometer - compared to the healthy foot.	1 week
Range of motion	Measurement of Range of motion using a Digital inclinometer - compared to the healthy foot	1 week

Collaborators and Investigators

• Sponsor: Clalit Health Services
• Investigators: Principal Investigator: Uzi Milman, MD, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL; Principal Investigator: HASAN KHAIRELDIN, MD, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL; Principal Investigator: SHARON ISRAELY, BA, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: May 24, 2010
• First Submitted That Met QC Criteria: June 15, 2010
• First Posted (Estimate): June 16, 2010

Study Record Updates

• Last Update Posted (Estimate): January 24, 2012
• Last Update Submitted That Met QC Criteria: January 21, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Physiotherapy; Plantar Fasciitis
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: K-10-0037-ctil