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

Primary Purpose

Nerve Compression Syndromes, Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tibial Nerve Mobilization
Foot-ankle range of motion exercises
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nerve Compression Syndromes

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kutahya Health Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nerve Mobilization Group

Control group

Arm Description

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

Only joint range of motion exercises

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 24, 2022
Last Updated
July 19, 2022
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05307354
Brief Title
The Effectiveness of Tibial Nerve Mobilization in Patients With Tarsal Tunnel Syndrome
Official Title
The Effectiveness of Tibial Nerve Mobilization in Patients With Tarsal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
July 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Compression Syndromes, Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nerve Mobilization Group
Arm Type
Experimental
Arm Description
Tibial nerve mobilization in addition to foot-ankle joint range of motion exercises
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Only joint range of motion exercises
Intervention Type
Other
Intervention Name(s)
Tibial Nerve Mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Foot-ankle range of motion exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
VAS, a scale consisting of a single line of 10 cm, was used to evaluate pain severity.
Time Frame
Change from Baseline at 4th weeks
Title
Evaluation of the tibial nerve with ultrasonography
Description
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.
Time Frame
Change from Baseline at 4th weeks
Title
Tinel's Sign
Description
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.
Time Frame
Change from Baseline at 4th weeks
Secondary Outcome Measure Information:
Title
Foot Function Index
Description
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.
Time Frame
Change from Baseline at 4th weeks
Title
Neuropathic pain questionnaire
Description
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.
Time Frame
Change from Baseline at 4th weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merve Akdeniz LEBLEBİCİER, MD
Organizational Affiliation
Kutahya Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kutahya Health Sciences University
City
Kütahya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Yes

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

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