Nerve Compression SyndromesNCT05307354
The Effectiveness of Tibial Nerve Mobilization in Patients With Tarsal Tunnel Syndrome
A study testing Tibial Nerve Mobilization and Foot-ankle range of motion exercises in people with Nerve Compression Syndromes and Neuropathic Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Nerve Compression Syndromes, Neuropathic Pain
- What is being tested?
- Tibial Nerve Mobilization and Foot-ankle range of motion exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 6 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Tibial Nerve Mobilization, Foot-ankle range of motion exercises
- Medical subject headings
- Nerve Compression Syndromes, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibial Nerve MobilizationOther
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.
Foot-ankle range of motion exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nerve Mobilization Group | Experimental | Tibial nerve mobilization in addition to foot-ankle joint range of motion exercises Receives: Other: Tibial Nerve Mobilization; Other: Foot-ankle range of motion exercises |
| Control group | Active comparator | Only joint range of motion exercises Receives: Other: Foot-ankle range of motion exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
VAS, a scale consisting of a single line of 10 cm, was used to evaluate pain severity.
Measured: 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.
Measured: 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.
Measured: Change from Baseline at 4th weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Change from Baseline at 4th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Apr 2022
- Primary completion15 Jun 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve Compression SyndromesStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merve Akdeniz LEBLEBİCİER, MD, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307354
- Sponsor's protocol ID
- KutahyaHSUtibialnerve
- Status last verified
- Mar 2022
- First submitted
- 24 Mar 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Tibial Nerve Mobilization in Patients With Tarsal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05307354
- Acronym / sponsor ID
- KutahyaHSUtibialnerve
- Conditions
- Nerve Compression Syndromes, Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve Mobilization Group | Experimental | Other: Tibial Nerve Mobilization, Other: Foot-ankle range of motion exercisesTibial nerve mobilization in addition to foot-ankle joint range of motion exercises |
| Control group | Active comparator | Other: Foot-ankle range of motion exercisesOnly joint range of motion exercises |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tibial Nerve MobilizationThe 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 | Nerve Mobilization Group |
| Foot-ankle range of motion exercisesIn 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. | Other | Control group, Nerve Mobilization Group |
Primary outcome
Visual analogue scale
Time frame: 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
Time frame: 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.
Tinel's Sign
Time frame: 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.
2 secondary outcomes
Foot Function Index
Time frame: Change from Baseline at 4th weeks
Neuropathic pain questionnaire
Time frame: Change from Baseline at 4th weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Undecided. Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Akdeniz LEBLEBİCİER, MD principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibial Nerve Mobilization and Foot-ankle range of motion exercises in people with Nerve Compression Syndromes and Neuropathic Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: Change from Baseline at 4th weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.