Tarsal Tunnel Syndrome and Fibromyalgia

NCT05135572 | Completed

• 1 other identifier: MLeblebicier1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Tarsal Tunnel Syndrome

Keywords

Tarsal Tunnel Syndrome, Fibromyalgia, Neuropathic pain, EMG

Outcome Measures

Primary Outcomes (3)

• Electrodiagnostic studies

  It is a neurological examination method based on the examination of the electrical potential of nerves and striated muscles.

  15 minutes

• 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

  3 minutes

• 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

  3 minutes

Study Arms (2)

control group

ACTIVE COMPARATOR

Fibromiyalgia patients with foot pain.

Diagnostic Test: Fibromiyalgia and foot pain

study group

EXPERIMENTAL

Patients with foot pain

Diagnostic Test: Fibromiyalgia and foot pain

Interventions

Fibromiyalgia and foot pain DIAGNOSTIC_TEST

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.

Also known as: Patients with foot pain

control group; study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age
• Diagnosed with fibromyalgia according to ACR criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Scıence University

Kütahya, Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tarsal Tunnel Syndrome; Fibromyalgia; Neuralgia

Condition Hierarchy (Ancestors)

Tibial Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: November 26, 2021
• Study Start: February 1, 2022
• Primary Completion: February 28, 2022
• Study Completion: March 1, 2022
• Last Updated: June 1, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)