Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06348017 |
| Other study ID # |
Yozgat City Hospital |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 19, 2023 |
| Est. completion date |
March 15, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Yozgat City Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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).
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:
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.
