Chronic Plantar FasciitisNCT06348017
Frequency of Neuropathic Pain in Patients With Plantar Fasciitis
An observational study of Chronic Plantar Fasciitis and Control Group, run by Yozgat City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Study Design This prospective cross-sectional study was undertaken between November 2023 and March 2024. Written and verbal informed consent was obtained from all patients. The study protocol was approved by University Human Research Ethics Committee (AEŞH-EK 1-2023-612). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Plantar Fasciitis, Control Group
- How many people
- 206 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Oct 2023to 15 Mar 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who applied to the City Hospital Physical Medicine and Rehabilitation outpatient clinic with heel pain that had been present for at least six months, received foot radiography and were diagnosed with PF Patients who did not have foot pain and had musculoskeletal pain for at least 6 months
Who may be able to join
- • Applied to the City Hospital Physical Medicine and Rehabilitation outpatient clinic with heel pain that had been present for at least six months
- received foot radiography and were diagnosed with PF
- aged 18 to 65 years as a patient group;
- musculoskeletal pain for at least 6 months
- who did not have foot pain
- aged 18 to 65 years as a control group
Who cannot join
- A history of diabetes, hypothyroidism and congestive heart failure
- A history of malignancy
- Vasculitis
- Neurological diseases that may cause neuropathic pain,
- Lumbar discopathy
- A previous history of fracture or surgery in the heel area
Show all 9Show fewer
- Received injections or ESWT treatment due to heel pain in the last 3 months
- Rheumatic diseases that may affect pain such as rheumatoid arthritis, ankylosing spondylitis, fibromyalgia
- Severe circulatory disorders on the side with pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency of Neuropathic Pain and Central Sensitization in Patients With Plantar Fasciitis
Study Design This prospective cross-sectional study was undertaken between November 2023 and March 2024. Written and verbal informed consent was obtained from all patients. The study protocol was approved by University Human Research Ethics Committee (AEŞH-EK 1-2023-612).
Patients While 106 patients who applied to the City Hospital Physical Medicine and Rehabilitation outpatient clinic with heel pain that had been present for at least six months, received foot radiography and were diagnosed with PF were included in the study as a patient group; 100 patients who did not have foot pain and had musculoskeletal pain for at least 6 months were included in the study as a control group, between November 2023 and March 2024. All the participants were aged 18 to 65 years. Patients with a history of diabetes, hypothyroidism and CKD, a history of malignancy, with vasculitis, neurological diseases that may cause neuropathic pain, lumbar discopathy, those with a previous history of fracture or surgery in the heel area, received injections or ESWT treatment due to heel pain in the last 3 months, rheumatic diseases that may affect pain such as rheumatoid arthritis, ankylosing spondylitis, fibromyalgia, and severe circulatory disorders on the side with pain, were excluded from the study. The study was commenced after obtaining the approval of the local ethics committee and informed consent of the participants.
All patients' personal information (age, gender, occupation, education information), general health information (smoking and alcohol use information, known chronic disease history, body mass index), severity of heel pain and when it started were recorded. While the Foot Function Index (FFI) scale, which evaluates the functionality of the foot, was applied to the patient group; the Visual Analog Scale (VAS), which evaluates pain intensity, the Pain-DETECT scale, which evaluates neuropathic pain, and the Central Sensitization Scale (CSI), which evaluates central sensitization, were applied to the patient and control groups. The details of the implementation of the instruments are as follows:
Read the detailed description
Visual Analog Scale (VAS) for the Evaluation of Pain and Fatigue For this evaluation, the patient is asked to mark his/her severity of pain and fatigue on a horizontal 10-cm line with number 0 on one end representing "no pain or no fatigue" and number 10 on the other end indicating "very severe pain or very severe fatigue".
Foot Function Index (FFI): Sub-parameters of FFI; pain, disability and activity limitation and is a scale consisting of a total of 23 items. The pain subscale includes nine items and measures the severity of foot pain in different situations. The disability subscale includes 9 items and evaluates the severity of the person's difficulty in performing functional activities due to foot problems. The activity limitation subscale includes 5 items and measures the person's activity limitations due to foot problems. People answer the questions with the Visual Analogue Scale (VAS), taking into account their foot conditions a week ago. A higher score indicates more pain, disability, and activity limitation. Turkish validity and reliability study was conducted by Yalıman et al. in 2014.
Pain-DETECT: The survey consists of 9 questions, with a score range of 1-38. Scores of 12 and below are considered as 'NA component is unlikely', scores between 13-18 are considered as 'NA component is uncertain', and scores of 19 and above are considered as 'NA component is possible'. Turkish validity and reliability study was conducted by Alkan et al in 2013.
Central Sensitization Scale (CSI): The survey consists of 25 questions. Each question is scored between 0 and 4 (0=never, 4=always). A score of forty and above 31 indicates the presence of CS with 81% sensitivity and 75% specificity. SS severity is defined as 0-29 subclinical, 30-39 mild, 40-49 moderate, 50-59 severe, 60 and above very severe. Turkish validity and reliability study was conducted by Keleş et al in 2021.
- Conditions
- Chronic Plantar Fasciitis, Control Group
- Keywords
- Plantar fasciitis, Neuropathic pain, Central sensitization, Pain-DETECT, Central Sensitization Scale, Foot Function Index
- Medical subject headings
- Fasciitis, Plantar, Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-DETECT
The survey consists of 9 questions, with a score range of 1-38. Scores of 12 and below are considered as 'NA component is unlikely', scores between 13-18 are considered as 'NA component is uncertain', and scores of 19 and above are considered as 'NA component is possible'. Turkish validity and reliability study was conducted by Alkan et al in 2013
Measured: One Time
Foot Function Index
Sub-parameters of FFI; pain, disability and activity limitation and is a scale consisting of a total of 23 items. The pain subscale includes nine items and measures the severity of foot pain in different situations. The disability subscale includes 9 items and evaluates the severity of the person's difficulty in performing functional activities due to foot problems. The activity limitation subscale includes 5 items and measures the person's activity limitations due to foot problems. People answer the questions with the Visual Analogue Scale (VAS), taking into account their foot conditions a week ago. A higher score indicates more pain, disability, and activity limitation. Turkish validity and reliability study was conducted by Yalıman et al. in 2014
Measured: One Time
Central Sensitization Scale
The survey consists of 25 questions. Each question is scored between 0 and 4 (0=never, 4=always). A score of forty and above 31 indicates the presence of central sensitization with 81% sensitivity and 75% specificity. SS severity is defined as 0-29 subclinical, 30-39 mild, 40-49 moderate, 50-59 severe, 60 and above very severe (12). Turkish validity and reliability study was conducted by Keleş et al in 2021
Measured: One Time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start19 Oct 2023
- Primary completion1 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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-control
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yozgat City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348017
- Sponsor's protocol ID
- Yozgat City Hospital
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 9 Apr 2024
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Neuropathic Pain and Central Sensitization in Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06348017
- Acronym / sponsor ID
- Yozgat City Hospital
- Conditions
- Chronic Plantar Fasciitis, Control Group
- Keywords
- Plantar fasciitis, Neuropathic pain, Central sensitization, Pain-DETECT, Central Sensitization Scale, Foot Function Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Yozgat City HospitalUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 4 Apr 2024 (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.
Study Design This prospective cross-sectional study was undertaken between November 2023 and March 2024. Written and verbal informed consent was obtained from all patients. The study protocol was approved by University Human Research Ethics Committee (AEŞH-EK 1-2023-612).
Patients While 106 patients who applied to the City Hospital Physical Medicine and Rehabilitation outpatient clinic with heel pain that had been present for at least six months, received foot radiography and were diagnosed with PF were included in the study as a patient group; 100 patients who did not have foot pain and had musculoskeletal pain for at least 6 months were included in the study as a control group, between November 2023 and March 2024. All the participants were aged 18 to 65 years. Patients with a history of diabetes, hypothyroidism and CKD, a history of malignancy, with vasculitis, neurological diseases that may cause neuropathic pain, lumbar discopathy, those with a previous history of fracture or surgery in the heel area, received injections or ESWT treatment due to heel pain in the last 3 months, rheumatic diseases that may affect pain such as rheumatoid arthritis, ankylosing spondylitis, fibromyalgia, and severe circulatory disorders on the side with pain, were excluded from the study. The study was commenced after obtaining the approval of the local ethics committee and informed consent of the participants.
All patients' personal information (age, gender, occupation, education information), general health information (smoking and alcohol use information, known chronic disease history, body mass index), severity of heel pain and when it started were recorded. While the Foot Function Index (FFI) scale, which evaluates the functionality of the foot, was applied to the patient group; the Visual Analog Scale (VAS), which evaluates pain intensity, the Pain-DETECT scale, which evaluates neuropathic pain, and the Central Sensitization Scale (CSI), which evaluates central sensitization, were applied to the patient and control groups. The details of the implementation of the instruments are as follows:
Detailed description
Visual Analog Scale (VAS) for the Evaluation of Pain and Fatigue For this evaluation, the patient is asked to mark his/her severity of pain and fatigue on a horizontal 10-cm line with number 0 on one end representing "no pain or no fatigue" and number 10 on the other end indicating "very severe pain or very severe fatigue".
Foot Function Index (FFI): Sub-parameters of FFI; pain, disability and activity limitation and is a scale consisting of a total of 23 items. The pain subscale includes nine items and measures the severity of foot pain in different situations. The disability subscale includes 9 items and evaluates the severity of the person's difficulty in performing functional activities due to foot problems. The activity limitation subscale includes 5 items and measures the person's activity limitations due to foot problems. People answer the questions with the Visual Analogue Scale (VAS), taking into account their foot conditions a week ago. A higher score indicates more pain, disability, and activity limitation. Turkish validity and reliability study was conducted by Yalıman et al. in 2014.
Pain-DETECT: The survey consists of 9 questions, with a score range of 1-38. Scores of 12 and below are considered as 'NA component is unlikely', scores between 13-18 are considered as 'NA component is uncertain', and scores of 19 and above are considered as 'NA component is possible'. Turkish validity and reliability study was conducted by Alkan et al in 2013.
Central Sensitization Scale (CSI): The survey consists of 25 questions. Each question is scored between 0 and 4 (0=never, 4=always). A score of forty and above 31 indicates the presence of CS with 81% sensitivity and 75% specificity. SS severity is defined as 0-29 subclinical, 30-39 mild, 40-49 moderate, 50-59 severe, 60 and above very severe. Turkish validity and reliability study was conducted by Keleş et al in 2021.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who applied to the City Hospital Physical Medicine and Rehabilitation outpatient clinic with heel pain that had been present for at least six months, received foot radiography and were diagnosed with PF Patients who did not have foot pain and had musculoskeletal pain for at least 6 months
Key inclusion criteria (6 listed)
- • Applied to the City Hospital Physical Medicine and Rehabilitation outpatient clinic with heel pain that had been present for at least six months
Key exclusion criteria (9 listed)
- A history of diabetes, hypothyroidism and congestive heart failure
- A history of malignancy
- Vasculitis
- Neurological diseases that may cause neuropathic pain,
- Lumbar discopathy
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
Pain-DETECT
Time frame: One Time
The survey consists of 9 questions, with a score range of 1-38. Scores of 12 and below are considered as 'NA component is unlikely', scores between 13-18 are considered as 'NA component is uncertain', and scores of 19 and above are considered as 'NA component is possible'. Turkish validity and reliability study was conducted by Alkan et al in 2013
Foot Function Index
Time frame: One Time
Sub-parameters of FFI; pain, disability and activity limitation and is a scale consisting of a total of 23 items. The pain subscale includes nine items and measures the severity of foot pain in different situations. The disability subscale includes 9 items and evaluates the severity of the person's difficulty in performing functional activities due to foot problems. The activity limitation subscale includes 5 items and measures the person's activity limitations due to foot problems. People answer the questions with the Visual Analogue Scale (VAS), taking into account their foot conditions a week ago. A higher score indicates more pain, disability, and activity limitation. Turkish validity and reliability study was conducted by Yalıman et al. in 2014
Central Sensitization Scale
Time frame: One Time
The survey consists of 25 questions. Each question is scored between 0 and 4 (0=never, 4=always). A score of forty and above 31 indicates the presence of central sensitization with 81% sensitivity and 75% specificity. SS severity is defined as 0-29 subclinical, 30-39 mild, 40-49 moderate, 50-59 severe, 60 and above very severe (12). Turkish validity and reliability study was conducted by Keleş et al in 2021
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 9 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Plantar Fasciitis and Control Group, run by Yozgat City 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 6 inclusion and 9 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 9 Apr 2024. 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?
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?
Pain-DETECT (time frame: One Time). The study lists 3 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 9 Apr 2024.