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临床试验/NCT05307354
NCT05307354已完成不适用

The Effectiveness of Tibial Nerve Mobilization in Patients With Tarsal Tunnel Syndrome

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Tinel's Sign

研究概览

简要总结

This randomized, clinical, single-blinded, controlledstudywasinitiallyplannedtoinclude 35 patients diagnosed with tarsal tunnel who applied to Kütahya Health Sciences University, Evliya Çelebi Training and Research Hospital, Physical Medicine and Rehabilitation outpatient clinic.Patients aged 20-55 years who were diagnosed with tarsal tunnel syndrome by electromyography (EMG) in the last 6 months were included in the study. The patients were randomized into two groups using the computer-assisted randomization method. Tibial nerve mobilization and foot-ankle range of motion exercises will be given to the study group, and only foot-ankle joint range of motion exercises will be given to the control group. All the patients were evaluated with the Visual Analog Scale (VAS), Foot Functional Index (FFI), Neuropathic Pain QuestionnaireN (NPQ) and Tibial Nerve ultrasonography before the intervention and at the fourth week of intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 20-55 years who were diagnosed with tarsal tunnel syndrome by electromyography (EMG) in the last 6 months were included in the study.

排除标准

  • Have a systemic inflammatory disease
  • Presence of a cognitive disorder, receiving psychotherapy or any psychiatric treatment, disease affecting the central nervous system
  • Being illiterate
  • Having hearing, vision problems
  • History of foot and ankle surgery
  • Any pathology that may cause pain in the foot joint diagnosed on physical examination
  • Inadequate function of any extremity that would prevent exercise
  • The presence of a balance disorder or a disease that can disrupt the balance
  • Diagnosis of advanced cardiac or lung disease for which exercise would be contraindicated

结局指标

主要结局

Tinel's Sign

时间窗: Change from Baseline at 4th weeks

It is performed by lightly tapping (percussing) over the nerve to elicit a sensation of tingling or "pins and needles" in the distribution of the Tibial nerve. The Tinel sign is the tingling or prickling sensation elicited by the percussion of an injured nerve trunk at or distal to the site of the lesion. The test is positive when a tingling or prickling sensation is felt in the distribution of the Tibial nerve.

Visual analogue scale

时间窗: Change from Baseline at 4th weeks

VAS, a scale consisting of a single line of 10 cm, was used to evaluate pain severity.

Evaluation of the tibial nerve with ultrasonography

时间窗: Change from Baseline at 4th weeks

Bilateral tibial nerve US evaluation using a 6-18 Mhz linear probe (Mindray-UMT 200, USA) will be performed by another clinician experienced in musculoskeletal ultrasonography and blind to the clinical evaluation findings of patients.

次要结局

  • Foot Function Index(Change from Baseline at 4th weeks)
  • Neuropathic pain questionnaire(Change from Baseline at 4th weeks)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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