Reliability of Functional Outcome Measures in Plantar Fascitis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT01145118
First received: May 24, 2010
Last updated: January 21, 2012
Last verified: January 2012
  Purpose

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.


Condition
Plantar Fasciitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reliability of Functional Outcome Measures in Plantar Fascitis Patients

Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • Functional Limitation [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Measurement of Functional Limitation using Foot Function Index (FFI) compared to the healthy foot


Secondary Outcome Measures:
  • Pain intensity [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Measurement of pain intensity using visual analog scale (VAS), compared to the healthy foot

  • Pain threshold [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Measurement of pain threshold using a Pressure Algometer, compared to the healthy foot

  • Muscle strength [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Measurement of Muscle strength in Plantar Flexion and Dorsi Flexion using Hand Held Dinamometer - compared to the healthy foot.

  • Range of motion [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Measurement of Range of motion using a Digital inclinometer - compared to the healthy foot


Estimated Enrollment: 80
Study Start Date: July 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Individuals referred to community physiotherapy center for plantar Fasceitis treatment.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145118

Locations
Israel
Clalit Health Services, Haifa and Western Galilee District
Haifa, Israel
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Uzi Milman, Director, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL., Clalit Health Services
ClinicalTrials.gov Identifier: NCT01145118     History of Changes
Other Study ID Numbers: K-10-0037-ctil
Study First Received: May 24, 2010
Last Updated: January 21, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Clalit Health Services:
Plantar Fasciitis
Physiotherapy

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases

ClinicalTrials.gov processed this record on September 16, 2014