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Tarsal Tunnel Syndrome and Fibromyalgia

Primary Purpose

Tarsal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fibromiyalgia and foot pain
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tarsal Tunnel Syndrome focused on measuring Tarsal Tunnel Syndrome, Fibromyalgia, Neuropathic pain, EMG

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-65 age
  • Diagnosed with fibromyalgia according to ACR criteria

Exclusion Criteria:

  • Have any severe mental or psychological disorder
  • Have significant hearing and/or vision loss
  • Presence of foot deformity, previous fracture, arthritis, tendon pathology that may cause foot pain detected in the physical examination of the foot and ankle joint.
  • Presence of systemic inflammatory disease
  • Having any systemic disease that may cause polyneuropathy.

Sites / Locations

  • Kutahya Health Scıence University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

study group

Arm Description

Fibromiyalgia patients with foot pain.

Patients with foot pain

Outcomes

Primary Outcome Measures

Electrodiagnostic studies
It is a neurological examination method based on the examination of the electrical potential of nerves and striated muscles.
Fibromyalgia Impact Questionnaire (FIQ)
This scale measures several patient characteristics over the past week: physical functioning, work status, depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being.The total FIQ score ranges from 0 to 100 and higher scores indicate severe effects of FMS. The minimal clinical important difference (MCID) for FIQ was reported to be minimum 14% or 8.1-point improvement
Neuropathic Pain Questionnaire.
This scala measures the type of pain, whether it has changed over time, and whether the pain is in one or more regions.This scala measures the type of pain, whether it has changed over time, and whether the pain is in one or more regions. It consists of 12 questions. Each question is scored between 0 and 100 points. It is multiplied by the coefficients determined for each question. All the resulting values are summed up, including fixed numbers. The result of the sum reflects the discriminant function score. Individuals with a score below 0 are predicted to have non-neuropathic pain, while those with a score of 0 or higher are predicted to have neuropathic pain

Secondary Outcome Measures

Full Information

First Posted
November 24, 2021
Last Updated
May 30, 2022
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05135572
Brief Title
Tarsal Tunnel Syndrome and Fibromyalgia
Official Title
What is the Relationship Between Tarsal Tunnel Syndrome and Foot Pain in Fibromyalgia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Widespread pain is observed in patients diagnosed with fibromyalgia, and lower extremity and foot pain are also common. In our study, we aimed to evaluate the relationship between foot pain and tarsal tunnel syndrome in female patients diagnosed with fibromyalgia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tarsal Tunnel Syndrome
Keywords
Tarsal Tunnel Syndrome, Fibromyalgia, Neuropathic pain, EMG

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
Fibromiyalgia patients with foot pain.
Arm Title
study group
Arm Type
Experimental
Arm Description
Patients with foot pain
Intervention Type
Diagnostic Test
Intervention Name(s)
Fibromiyalgia and foot pain
Other Intervention Name(s)
Patients with foot pain
Intervention Description
Sensory and motor conduction studies will be performed in the lower extremities. Nerve conduction studies will be performed by another physician unaware of the patient's diagnosisFunctional status will be evaluated by using the Turkish version of the Fibromyalgia Impact Questionnaire (FIQ).Neuropathic Pain will be evalutaed by using the Turkish version of the Neuropathic Pain Questionnaire.
Primary Outcome Measure Information:
Title
Electrodiagnostic studies
Description
It is a neurological examination method based on the examination of the electrical potential of nerves and striated muscles.
Time Frame
15 minutes
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
This scale measures several patient characteristics over the past week: physical functioning, work status, depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being.The total FIQ score ranges from 0 to 100 and higher scores indicate severe effects of FMS. The minimal clinical important difference (MCID) for FIQ was reported to be minimum 14% or 8.1-point improvement
Time Frame
3 minutes
Title
Neuropathic Pain Questionnaire.
Description
This scala measures the type of pain, whether it has changed over time, and whether the pain is in one or more regions.This scala measures the type of pain, whether it has changed over time, and whether the pain is in one or more regions. It consists of 12 questions. Each question is scored between 0 and 100 points. It is multiplied by the coefficients determined for each question. All the resulting values are summed up, including fixed numbers. The result of the sum reflects the discriminant function score. Individuals with a score below 0 are predicted to have non-neuropathic pain, while those with a score of 0 or higher are predicted to have neuropathic pain
Time Frame
3 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 age Diagnosed with fibromyalgia according to ACR criteria Exclusion Criteria: Have any severe mental or psychological disorder Have significant hearing and/or vision loss Presence of foot deformity, previous fracture, arthritis, tendon pathology that may cause foot pain detected in the physical examination of the foot and ankle joint. Presence of systemic inflammatory disease Having any systemic disease that may cause polyneuropathy.
Facility Information:
Facility Name
Kutahya Health Scıence University
City
Kutahya
State/Province
Kütahya
ZIP/Postal Code
43000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Tarsal Tunnel Syndrome and Fibromyalgia

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