Plantar FasciitisNCT01145118
Reliability of Functional Outcome Measures in Plantar Fascitis Patients
An observational study of Plantar Fasciitis, run by Clalit Health Services at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Plantar Fasciitis
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2010to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals referred to community physiotherapy center for plantar Fasceitis treatment.
Who may be able to join
- Unilateral plantar fasciitis
- Painful first step in the morning
- Calcaneal soreness in palpation
- Insured by Clalit Health Care Services
- Signed informed consent
Who cannot join
- Ankle or foot surgery
- Congenital deformation of foot
- Lower limb spasticity
- Using assistive devices
- Bilateral plantar fasciitis
- Refuse to participate or sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Plantar Fasciitis
- Keywords
- Plantar Fasciitis, Physiotherapy
- Medical subject headings
- Fasciitis, Plantar
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Limitation
Measurement of Functional Limitation using Foot Function Index (FFI) compared to the healthy foot
Measured: 1 week
Secondary outcomes (4)
Pain intensity
Measurement of pain intensity using visual analog scale (VAS), compared to the healthy foot
Measured: 1 week
Pain threshold
Measurement of pain threshold using a Pressure Algometer, compared to the healthy foot
Measured: 1 week
Muscle strength
Measurement of Muscle strength in Plantar Flexion and Dorsi Flexion using Hand Held Dinamometer - compared to the healthy foot.
Measured: 1 week
Range of motion
Measurement of Range of motion using a Digital inclinometer - compared to the healthy foot
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uzi Milman, Clalit Health Services
- Investigators
- Uzi Milman, MD, Principal investigator, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAELHASAN KHAIRELDIN, MD, Principal investigator, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAELSHARON ISRAELY, BA, Principal investigator, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145118
- Sponsor's protocol ID
- K-10-0037-ctil
- Status last verified
- Jan 2012
- First submitted
- 24 May 2010
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Functional Outcome Measures in Plantar Fascitis Patients
- ClinicalTrials.gov ID
- NCT01145118
- Acronym / sponsor ID
- K-10-0037-ctil
- Conditions
- Plantar Fasciitis
- Keywords
- Plantar Fasciitis, Physiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals referred to community physiotherapy center for plantar Fasceitis treatment.
Key inclusion criteria (5 listed)
- Unilateral plantar fasciitis
- Painful first step in the morning
- Calcaneal soreness in palpation
- Insured by Clalit Health Care Services
- Signed informed consent
Key exclusion criteria (6 listed)
- Ankle or foot surgery
- Congenital deformation of foot
- Lower limb spasticity
- Using assistive devices
- Bilateral plantar fasciitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Limitation
Time frame: 1 week
Measurement of Functional Limitation using Foot Function Index (FFI) compared to the healthy foot
4 secondary outcomes
Pain intensity
Time frame: 1 week
Pain threshold
Time frame: 1 week
Muscle strength
Time frame: 1 week
Range of motion
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uzi Milman, MD principal investigator
Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
HASAN KHAIRELDIN, MD principal investigator
Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
SHARON ISRAELY, BA principal investigator
Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plantar Fasciitis, run by Clalit Health Services at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Limitation (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2012.