Tarsal Tunnel Syndrome and Fibromyalgia

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

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.

Study Overview

• Status: Completed
• Conditions: Tarsal Tunnel Syndrome
• Intervention / Treatment: Diagnostic test: Fibromiyalgia and foot pain

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kütahya
    • Kutahya, Kütahya, Turkey, 43000
      • Kutahya Health Scıence University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Tarsal Tunnel Syndrome, Fibromyalgia, Neuropathic pain, EMG
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Tibial Neuropathy; Syndrome; Fibromyalgia; Myofascial Pain Syndromes; Tarsal Tunnel Syndrome
• Other Study ID Numbers: MLeblebicier1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No