Clinical trial NCT01145118: Reliability of Functional Outcome Measures in Plantar Fascitis Patients
Official title: Reliability of Functional Outcome Measures in Plantar Fascitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plantar Fasciitis
Keywords: Plantar Fasciitis
Physiotherapy
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2010-06-16
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals referred to community physiotherapy center for plantar Fasceitis treatment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Limitation
timeFrame: 1 week
Secondary outcomes:
measure: Pain intensity
timeFrame: 1 week
measure: Pain threshold
timeFrame: 1 week
measure: Muscle strength
timeFrame: 1 week
measure: Range of motion
timeFrame: 1 week
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Clalit Health Services, Haifa and Western Galilee District
Study officials:
affiliation: Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
name: Uzi Milman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
name: HASAN KHAIRELDIN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
name: SHARON ISRAELY, BA
role: PRINCIPAL_INVESTIGATOR
References: