Tarsal Tunnel Syndrome and Fibromyalgia

Sponsor

Kutahya Health Sciences University (Other)

Overall Status

Completed

CT.gov ID

NCT05135572

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

54.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tarsal Tunnel Syndrome	Diagnostic Test: Fibromiyalgia and foot pain	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

What is the Relationship Between Tarsal Tunnel Syndrome and Foot Pain in Fibromyalgia Patients

Actual Study Start Date :

Feb 1, 2022

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group Fibromiyalgia patients with foot pain.	Diagnostic Test: Fibromiyalgia and foot pain 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. Other Names: Patients with foot pain
Experimental: study group Patients with foot pain	Diagnostic Test: Fibromiyalgia and foot pain 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. Other Names: Patients with foot pain

Arm

Intervention/Treatment

Active Comparator: control group

Fibromiyalgia patients with foot pain.

Diagnostic Test: Fibromiyalgia and foot pain

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.

Other Names:

Patients with foot pain

Experimental: study group

Patients with foot pain

Diagnostic Test: Fibromiyalgia and foot pain

Other Names:

Patients with foot pain

Outcome Measures

Primary Outcome Measures

Electrodiagnostic studies [15 minutes]
It is a neurological examination method based on the examination of the electrical potential of nerves and striated muscles.
Fibromyalgia Impact Questionnaire (FIQ) [3 minutes]
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. [3 minutes]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kutahya Health Scıence University	Kutahya	Kütahya	Turkey	43000

Sponsors and Collaborators

Kutahya Health Sciences University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kutahya Health Sciences University

ClinicalTrials.gov Identifier:

NCT05135572

Other Study ID Numbers:

MLeblebicier1

First Posted:

Nov 26, 2021

Last Update Posted:

Jun 1, 2022

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kutahya Health Sciences University

Tarsal Tunnel Syndrome, Fibromyalgia, Neuropathic pain, EMG

Additional relevant MeSH terms:

Fibromyalgia

Myofascial Pain Syndromes

Tarsal Tunnel Syndrome

Syndrome

Study Results

No Results Posted as of Jun 1, 2022