Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348017
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-03-28
Brief Title:
Frequency of Neuropathic Pain in Patients With Plantar Fasciitis
Sponsor:
Yozgat City Hospital
Organization:
Yozgat City Hospital
Study Overview
Official Title:
Frequency of Neuropathic Pain and Central Sensitization in Patients With Plantar Fasciitis
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 hisher 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 persons difficulty in performing functional activities due to foot problems The activity limitation subscale includes 5 items and measures the persons 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 0never 4always 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
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 persons difficulty in performing functional activities due to foot problems The activity limitation subscale includes 5 items and measures the persons 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 0never 4always 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None