Reliability of Functional Outcome Measures in Plantar Fascitis Patients

Completed

• Conditions: Plantar Fasciitis

• Registration Number: NCT01145118
• Lead Sponsor: Clalit Health Services

Brief Summary

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.

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 Timeline

• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-16
• Study Start: 2010-07
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-21
• Last Update Posted: 2012-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Limitation	1 week	Measurement of Functional Limitation using Foot Function Index (FFI) compared to the healthy foot

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clalit Health Services, Haifa and Western Galilee District; 🇮🇱 Haifa, Israel