Reliability of Functional Outcome Measures in Plantar Fascitis Patients

Plantar Fasciitis Clinical Trial

Official title:

Reliability of Functional Outcome Measures in Plantar Fascitis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145118
• Other study ID #: K-10-0037-ctil
• Status: Completed
• Phase: N/A
• First received: May 24, 2010
• Last updated: January 21, 2012
• Start date: July 2010
• Est. completion date: May 2011

Study information

• Verified date: January 2012
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Locations

Country	Name	City	State
Israel	Clalit Health Services, Haifa and Western Galilee District	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Limitation	Measurement of Functional Limitation using Foot Function Index (FFI) compared to the healthy foot	1 week	No
Secondary	Pain intensity	Measurement of pain intensity using visual analog scale (VAS), compared to the healthy foot	1 week	No
Secondary	Pain threshold	Measurement of pain threshold using a Pressure Algometer, compared to the healthy foot	1 week	No
Secondary	Muscle strength	Measurement of Muscle strength in Plantar Flexion and Dorsi Flexion using Hand Held Dinamometer - compared to the healthy foot.	1 week	No
Secondary	Range of motion	Measurement of Range of motion using a Digital inclinometer - compared to the healthy foot	1 week	No