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Tarsal Tunnel Syndrome and Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05135572
Recruitment Status : Completed
First Posted : November 26, 2021
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
Kutahya Health Sciences University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : February 1, 2022
Actual Primary Completion Date : February 28, 2022
Actual Study Completion Date : March 1, 2022


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 Name: 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 Name: Patients with foot pain




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05135572


Locations
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Turkey
Kutahya Health Scıence University
Kutahya, Kütahya, Turkey, 43000
Sponsors and Collaborators
Kutahya Health Sciences University
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Responsible Party: Kutahya Health Sciences University
ClinicalTrials.gov Identifier: NCT05135572    
Other Study ID Numbers: MLeblebicier1
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kutahya Health Sciences University:
Tarsal Tunnel Syndrome, Fibromyalgia, Neuropathic pain, EMG
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Tarsal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Tibial Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Nerve Compression Syndromes