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

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.

Study Overview

• Status: Completed
• Conditions: Nerve Compression Syndromes; Neuropathic Pain
• Intervention / Treatment: Other: Tibial Nerve Mobilization; Other: Foot-ankle range of motion exercises

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kütahya, Turkey
    • Kütahya Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nerve Mobilization Group; Tibial nerve mobilization in addition to foot-ankle joint range of motion exercises	Other: Tibial Nerve Mobilization; The person performing tibial nerve mobilization will start mobilization by keeping the lower extremity in a horizontal position, with the patient's hip and knee in 45° flexion and ankle in neutral position. Then, in order to mobilize the tibial nerve better, the patient will bring the patient's toes to the extension position, the ankle to the dorsiflexion and eversion position, and the knee joint to the extension to provide appropriate stabilization. Finally, while the patient is in this position, mobilization will be completed by plantar flexion of the distal ankle and flexion of the toes to allow the nerve to slide further distally. This mobilization technique will be performed by an experienced physician/physiotherapist twice a week for 4 weeks, and the patients will be given 5 sets of 10 cycles with a 1-minute rest period in each set.; Other: Foot-ankle range of motion exercises; In exercise program, foot-ankle joint range of motion exercises will be given. In our study, all exercises will be explained and performed once under the supervision of a physiotherapist, and then the participants will be asked to do all exercises with 10 repetitions, 3 times a day, for four weeks, without the supervision of a physiotherapist.
Active Comparator: Control group; Only joint range of motion exercises	Other: Foot-ankle range of motion exercises; In exercise program, foot-ankle joint range of motion exercises will be given. In our study, all exercises will be explained and performed once under the supervision of a physiotherapist, and then the participants will be asked to do all exercises with 10 repetitions, 3 times a day, for four weeks, without the supervision of a physiotherapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	VAS, a scale consisting of a single line of 10 cm, was used to evaluate pain severity.	Change from Baseline at 4th weeks
Evaluation of the tibial nerve with ultrasonography	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.	Change from Baseline at 4th weeks
Tinel's Sign	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.	Change from Baseline at 4th weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot Function Index	The severity of foot pain was scored with 23 items measuring the degree of difficulty in performing various functional activities due to foot problems and activity limitations due to foot problems. Turkish validity and reliability of the questionnaire was determined by Yalıman et al.	Change from Baseline at 4th weeks
Neuropathic pain questionnaire	Neuropathic pain questionnaire consists of 12 questions. Of the 12 questions, 10 are related to the character of the pain while two questions are related to sensitivity changes.	Change from Baseline at 4th weeks

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Principal Investigator: Merve Akdeniz Leblebicier, MD, Kütahya Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): July 6, 2022

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Polyneuropathies; Tibial Neuropathy; Syndrome; Neuralgia; Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy; Tarsal Tunnel Syndrome
• Other Study ID Numbers: KutahyaHSUtibialnerve

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Yes

Drug and device information, study documents

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