Plantar Fasciitis, ChronicNCT04271696
Comparison of Responsiveness of Different Pain and Disability Measurements in Plantar Fasciitis
An observational study of Plantar Fasciitis, Chronic, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study is compare the frequently used pain and disability assessment questionnaires before and after 5 sessions of standard treatment for patients admitted to the Physical Medicine and Rehabilitation outpatient clinic for plantar fasciitis and who were queued to receive extracorporeal shock wave… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis, Chronic
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Feb 2020to 1 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients queued for ESWT
Who may be able to join
- Patients 18 years and older
- Patients with chronic heel complaints for more than 1 month
- Patients queued for ESWT
Who cannot join
- Patients under the age of 18
- Patients who do not want to participate in the study voluntarily
- Patient undergone physical therapy for the same heel in the last 6 months
- Patients treated for heel pain
- Rheumatologic diseases that cause heel pain (ankylosing spondylitis, Behçet's disease)
- Neurological diseases (such as diabetic polyneuropathy, postpolio syndrome)
- Patients with malignancy
- Illiterate patients with speech pathology
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa Training and Research Hospital
Istanbul, 34255
Mehmet Akif Guler, M.D., 05054930098, makifguler89@gmail.com
About this study
Official title: Comparison of Responsiveness of Different Pain and Disability Measurements in Patients With Plantar Fasciitis
The aim of the present study is compare the frequently used pain and disability assessment questionnaires before and after 5 sessions of standard treatment for patients admitted to the Physical Medicine and Rehabilitation outpatient clinic for plantar fasciitis and who were queued to receive extracorporeal shock wave therapy (ESWT) treatment.
Read the detailed description
The study was designed as prospective observational research. Between December 2019 and May 2020, 90 patients who were admitted to the Physical Therapy and Rehabilitation outpatient clinic for ESWT were planned to be included in the study. Pre-treatment pain values of patients with 3 different examination methods (visual analog scale, numerical pain scale and heel sensitivity index), 3 different disability index Foot function index, Foot and Ankle Outcome Score, The American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score will be used.
These methods will be evaluated before and after ESWT treatment and the responsiveness and minimal clinically important difference of the questionnaires will be compared.
- Conditions
- Plantar Fasciitis, Chronic
- Keywords
- Extracorporeal Shockwave Therapy, Minimal Clinically Important Difference, Pain Measurement, Patient Reported Outcome Measures, Plantar Fasciitis, Responsiveness
- Medical subject headings
- Fasciitis, Plantar
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Pain severity assessment on a line from 0 to 10 points. As "0" means no pain and "10" points is the worst pain ever.
Measured: 15 days
Numeric Rating Scale
11 points scale as 0 means no pain and 10 points means worst pain ever.
Measured: 15 days
Heel Tenderness Index
0-3 points according to the palpation of the heel. "0" means no pain, "1" = painful, "2" = painful and winces and "3"= painful,winces and withdraws.
Measured: 15 days
Foot Function Index
A Foot Function Index was developed in 1991 to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. It is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. Higher scores show higher disability and worst outcomes.
Measured: 15 days
Foot and Ankle Outcome Score
The Foot and Ankle Outcome Score is an adaption of Knee injury and Osteoarthritis Outcome Score that assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and foot/ankle related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible foot/ankle symptoms and 100 indicating no foot/ankle symptoms.
Measured: 15 days
American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
The questionnaire includes nine items that can be divided into three subscales (pain, function and alignment). Each of the nine items is scored, accumulating to a total score ranging from 0 points (indicating severe pain and impairment) to 100 points (no symptoms or impairment).
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start13 Feb 2020
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar Fasciitis, ChronicStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital
- Investigators
- Ebru Y Yalcınkaya, Ass. Prof., Study chair, Gaziosmanpasa Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271696
- Sponsor's protocol ID
- GaziosmanpasaTREH12
- Status last verified
- Feb 2020
- First submitted
- 13 Feb 2020
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Responsiveness of Different Pain and Disability Measurements in Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT04271696
- Acronym / sponsor ID
- GaziosmanpasaTREH12
- Conditions
- Plantar Fasciitis, Chronic
- Keywords
- Extracorporeal Shockwave Therapy, Minimal Clinically Important Difference, Pain Measurement, Patient Reported Outcome Measures, Plantar Fasciitis, Responsiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 17 Feb 2020 (actual)
- 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.
The aim of the present study is compare the frequently used pain and disability assessment questionnaires before and after 5 sessions of standard treatment for patients admitted to the Physical Medicine and Rehabilitation outpatient clinic for plantar fasciitis and who were queued to receive extracorporeal shock wave therapy (ESWT) treatment.
Detailed description
The study was designed as prospective observational research. Between December 2019 and May 2020, 90 patients who were admitted to the Physical Therapy and Rehabilitation outpatient clinic for ESWT were planned to be included in the study. Pre-treatment pain values of patients with 3 different examination methods (visual analog scale, numerical pain scale and heel sensitivity index), 3 different disability index Foot function index, Foot and Ankle Outcome Score, The American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score will be used.
These methods will be evaluated before and after ESWT treatment and the responsiveness and minimal clinically important difference of the questionnaires will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients queued for ESWT
Key inclusion criteria (3 listed)
- Patients 18 years and older
- Patients with chronic heel complaints for more than 1 month
- Patients queued for ESWT
Key exclusion criteria (8 listed)
- Patients under the age of 18
- Patients who do not want to participate in the study voluntarily
- Patient undergone physical therapy for the same heel in the last 6 months
- Patients treated for heel pain
- Rheumatologic diseases that cause heel pain (ankylosing spondylitis, Behçet's disease)
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
Visual Analog Scale
Time frame: 15 days
Pain severity assessment on a line from 0 to 10 points. As "0" means no pain and "10" points is the worst pain ever.
Numeric Rating Scale
Time frame: 15 days
11 points scale as 0 means no pain and 10 points means worst pain ever.
Heel Tenderness Index
Time frame: 15 days
0-3 points according to the palpation of the heel. "0" means no pain, "1" = painful, "2" = painful and winces and "3"= painful,winces and withdraws.
Foot Function Index
Time frame: 15 days
A Foot Function Index was developed in 1991 to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. It is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. Higher scores show higher disability and worst outcomes.
Foot and Ankle Outcome Score
Time frame: 15 days
The Foot and Ankle Outcome Score is an adaption of Knee injury and Osteoarthritis Outcome Score that assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and foot/ankle related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible foot/ankle symptoms and 100 indicating no foot/ankle symptoms.
American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
Time frame: 15 days
The questionnaire includes nine items that can be divided into three subscales (pain, function and alignment). Each of the nine items is scored, accumulating to a total score ranging from 0 points (indicating severe pain and impairment) to 100 points (no symptoms or impairment).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
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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.
Ebru Y Yalcınkaya, Ass. Prof. study chair
Gaziosmanpasa Training and Research Hospital
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, Chronic, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Feb 2020. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet A Guler, M.D. (+905054930098, makifguler89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 15 days). The study lists 6 primary outcomes in all. 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 19 Feb 2020.