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

NCT05307354 | Completed

• 1 other identifier: KutahyaHSUtibialnerve
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nerve Compression Syndromes; Neuropathic Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Foot Function Index

  Change from Baseline at 4th weeks

• Neuropathic pain questionnaire

  Change from Baseline at 4th weeks

Study Arms (2)

Nerve Mobilization Group

EXPERIMENTAL

Tibial nerve mobilization in addition to foot-ankle joint range of motion exercises

Other: Tibial Nerve Mobilization; Other: Foot-ankle range of motion exercises

Control group

ACTIVE COMPARATOR

Only joint range of motion exercises

Other: Foot-ankle range of motion exercises

Interventions

Tibial Nerve Mobilization OTHER

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.

Nerve Mobilization Group

Foot-ankle range of motion exercises OTHER

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.

Control group; Nerve Mobilization Group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nerve Compression Syndromes; Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Merve Akdeniz LEBLEBİCİER, MD

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 1, 2022
• Study Start: April 1, 2022
• Primary Completion: June 15, 2022
• Study Completion: July 6, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-03

Locations

TU (1)