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Completed

NCT Number: NCT05135572

Tarsal Tunnel Syndrome and Fibromyalgia

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.

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Key information

Conditions

Tarsal Tunnel Syndrome Fibromyalgia Mononeuropathies Muscular Diseases Musculoskeletal Diseases Nerve Compression Syndromes Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rheumatic Diseases Signs and Symptoms Tibial Neuropathy

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Scıence University

Kütahya, 43000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Patients with foot pain

Primary outcomes

  1. Electrodiagnostic studies

    Time frame: 15 minutes

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

  2. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: 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

  3. Neuropathic Pain Questionnaire.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2021
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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