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Reliability of Functional Outcome Measures in Plantar Fascitis Patients

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ClinicalTrials.gov Identifier: NCT01145118
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : January 24, 2012
Sponsor:
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services

Tracking Information
First Submitted Date May 24, 2010
First Posted Date June 16, 2010
Last Update Posted Date January 24, 2012
Study Start Date July 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2010)
Functional Limitation [ Time Frame: 1 week ]
Measurement of Functional Limitation using Foot Function Index (FFI) compared to the healthy foot
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 15, 2010)
  • Pain intensity [ Time Frame: 1 week ]
    Measurement of pain intensity using visual analog scale (VAS), compared to the healthy foot
  • Pain threshold [ Time Frame: 1 week ]
    Measurement of pain threshold using a Pressure Algometer, compared to the healthy foot
  • Muscle strength [ Time Frame: 1 week ]
    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 ]
    Measurement of Range of motion using a Digital inclinometer - compared to the healthy foot
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Reliability of Functional Outcome Measures in Plantar Fascitis Patients
Official Title Reliability of Functional Outcome Measures in Plantar Fascitis Patients
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Individuals referred to community physiotherapy center for plantar Fasceitis treatment.
Condition Plantar Fasciitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: June 15, 2010)
80
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01145118
Other Study ID Numbers K-10-0037-ctil
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Uzi Milman, Clalit Health Services
Study Sponsor Clalit Health Services
Collaborators Not Provided
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
PRS Account Clalit Health Services
Verification Date January 2012