Carpal Tunnel SyndromeNCT06554405
Bilateral vs. Unilateral Neuromobilization in Carpal Tunnel Syndrome
A study testing Unilateral Intervention and Bilateral Intervention in people with Carpal Tunnel Syndrome, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate whether bilateral (both extremities together) neuromobilization is superior to unilateral (only the affected side) neuromobilization in individuals diagnosed with Carpal Tunnel Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Unilateral Intervention and Bilateral Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Aug 2024to 20 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with CTS,
- Aged 18 and above,
- Without any other conditions in either upper extremity (such as trigger finger, osteoarthritis, tenosynovitis)
Who cannot join
- Individuals with a history of surgery, trauma, or fracture in the same upper extremity,
- Those who have received an injection for CTS in the last 3 months,
- Those with poor cooperation,
- Those participating in any other treatment program during the study,
- Those with a history of uncontrolled systemic diseases or systemic diseases involved in the etiology of CTS (such as diabetes, thyroid diseases, rheumatoid arthritis),
- Those who have used orthoses regularly and/or received physiotherapy in the last 3 months,
- Individuals with marked thenar atrophy requiring early surgical intervention
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Sciences
Ankara, Ankara
About this study
Official title: Examining the Effects of Bilateral Neuromobilization in Patients With Carpal Tunnel Syndrome: Comparison Study With Unilateral Application
This study aims to investigate whether bilateral (both extremities together) neuromobilization is superior to unilateral (only the affected side) neuromobilization in individuals diagnosed with Carpal Tunnel Syndrome.
Read the detailed description
Carpal Tunnel Syndrome (CTS) is defined as an upper extremity nerve entrapment resulting from the compression of the median nerve at the wrist level. It is the most common entrapment neuropathy. Patients with CTS experience numbness, tingling, and pain in the hand, which can sometimes extend to the arm, along with hand weakness and thenar atrophy. These symptoms typically worsen after hand use and at night. While clinical findings are absent in the early stages of the disease, sensory and strength loss is observed in the areas innervated by the median nerve in advanced stages.
The pathophysiology of CTS includes hypertrophic changes in the synovial tissue of the flexor tendon, connective tissue changes in the median nerve, conduction disturbances, and increased pressure in the carpal tunnel.
Treatment is tailored to the patient's symptoms. Conservative treatment is preferred in mild to moderate stages, while surgical intervention may be necessary in advanced stages. All patients should receive education on ergonomics aimed at reducing symptoms in daily life.
Conservative treatment for CTS includes nerve mobilization techniques, the use of orthoses to maintain the wrist in a neutral position, electrotherapy (ESWT, laser), manual therapy, kinesiotaping, corticosteroid and platelet-rich plasma (PRP) injections, and anti-inflammatory medications. Patients who do not respond to conservative treatment are referred for surgery.
Neural structures are capable of tolerating significant tension and compression forces encountered during daily activities and sports. This capability is due to the connective tissue sheath surrounding the nerve.
The musculoskeletal system creates an environment that surrounds the nervous system, and its movements affect peripheral nerves. With the excursion (sliding) movement, compression on the peripheral nerve decreases. Clinical neuromobilization is a manual therapy method that integrates the mechanics and physiology of the nervous system with musculoskeletal function. Neuromobilization (NM) aims to balance the relationship between neural tissues and surrounding mechanical tissues, thereby regulating optimal physiological functions.
The aim of using neuromobilization exercises with sliding techniques in nerve entrapments is to increase axonal transport and improve nerve conduction. It has been suggested that these exercises can reduce pressure within the nerve, improve its blood supply, and thus contribute to nerve regeneration. Recent studies in the literature report that neuromobilization exercises have supportive effects in pain improvement, reduction of distal latency time, and increased pinch strength. A systematic review indicated these effects as pain improvement, lowering the pain threshold, improving function, and avoiding surgery. It was stated that neuromobilization exercises added to the CTS treatment program accelerate the rehabilitation process and enhance recovery.
Although there are studies in the literature proving the superiority of neuromobilization over other treatment methods, the number of studies investigating the application of neuromobilization to the unaffected side is limited. Considering that the connective tissue sheaths surrounding peripheral nerves in both upper extremities are connected via the central nervous system, it is hypothesized that neuromobilization applied to the unaffected side or bilaterally might be more effective on the symptomatic side compared to unilateral application. However, studies that consider this connection and include the unaffected side in treatment are significantly lacking.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Unilateral Intervention, Bilateral Intervention
- Keywords
- Carpal Tunnel Syndrome, Neuromobilization, Median Nerve
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral InterventionOther
Treatment plan will be applied to the symptomatic side.
Bilateral InterventionOther
Treatment plan will be applied to the symptomatic and nonsymptomatic sides.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Intervention | Active comparator | Patients will be treated for 4 weeks (2 days in a week, 8 sessions). The treatment plan involves massage therapy, neuromobilization exercises and cold application. In this arm, treatment plan will be applied only for the symptomatic side. The rest of the treatment will be the same as the other group. Receives: Other: Unilateral Intervention |
| Bilateral Intervention | Experimental | Patients will be treated for 4 weeks (2 days in a week, 8 sessions). The treatment plan involves massage therapy, neuromobilization exercises and cold application. In this arm, treatment plan will be applied only for both symptomatic and nonsymptomatic sides. The rest of the treatment will be the same as the other group. Receives: Other: Bilateral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Severity Assessment (Boston Carpal Tunnel Syndrome Questionnaire- Symptom Severity Scale)
The Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ), developed in 1993, will be used to assess individuals' functional status and symptoms. The Turkish validity and reliability study of the test has been conducted. The test consists of two self-assessment sections: one with 11 questions evaluating symptom severity and another with 8 questions evaluating functional capacity. It is a Likert-type questionnaire, where 1 indicates the best condition and 5 indicates the worst condition. The total score is calculated by dividing the total points by the number of questions, resulting in a score between 1 and 5.
Measured: Four weeks
Secondary outcomes (5)
Light Touch and Pressure Sense
Light touch and pressure assessment will be performed using the Semmes-Weinstein Monofilament test. This test kit contains five filaments ranging from 2.83 (0.07 grams of force) to 6.65 (300 grams of force). These filaments are applied to the skin. During the assessment, the individual should not see the filament. First, the unaffected side is assessed, followed by the affected side. During the evaluation, the filament is applied to the skin at a 90-degree angle and held for 1.5 seconds. The application sites for the median nerve are the pulp of the first finger and the pulp of the second finger. The patient is asked if they can feel the filament and should respond with "yes" or "no." The evaluation starts with the lowest filament, 2.83, which represents normal sensation. If the patient responds "yes," their sensation is recorded as normal. If not, progressively higher-value filaments are used until a "yes" response is obtained.
Measured: Four weeks
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) will be used for pain assessment. The individual will make a mark on a 10-centimeter horizontal line, where 0 indicates no pain and 10 indicates maximum pain. This marking will be done separately for both rest and activity periods. The data will be recorded in centimeters.
Measured: Four weeks
Gross Grip Strength
For gross grip strength measurement, a hydraulic hand dynamometer (Baseline®, USA) will be used. The measurement will be conducted in the standard position specified by the American Society of Hand Therapists. In this position, the individual will sit on a chair with back support, with the elbow at 90 degrees of flexion and the wrist in a neutral position. The person will be asked to squeeze the dynamometer with maximum force. The measurement will be repeated three times, and the average will be recorded in kg/f.
Measured: Four weeks
Pinch Grip Strength
For pinch grip strength measurement, a mechanical pinch meter (Baseline®, USA) will be used. Lateral (key) pinch, two-point (bipod, tip) pinch, and three-point (tripod, palmar) pinch measurements will be performed separately. For the lateral pinch, the patient will be asked to squeeze the end of the pinch meter between the thumb and the lateral surface of the middle phalanx of the second finger with maximum force. For the two-point pinch strength measurement, the patient will be asked to squeeze the pinch meter between the thumb and the pulp of the second finger, and for the three-point pinch strength measurement, between the thumb, the second finger, and the third finger as tightly as possible. Assessments will be conducted bilaterally, starting with the healthy side. The measurements will be repeated three times for each side, and the averages will be recorded in kg/f.
Measured: Four weeks
Functional Level Assessment (Boston Carpal Tunnel Syndrome Questionnaire-Functional Status Scale)
The Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ), developed in 1993, will be used to assess individuals' functional status and symptoms. The Turkish validity and reliability study of the test has been conducted. The test consists of two self-assessment sections: one with 11 questions evaluating symptom severity and another with 8 questions evaluating functional capacity. It is a Likert-type questionnaire, where 1 indicates the best condition and 5 indicates the worst condition. The total score is calculated by dividing the total points by the number of questions, resulting in a score between 1 and 5.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start31 Aug 2024
- Primary completion30 May 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Parallel groups
- Model description
- Participants will be grouped according to randomization into unilateral or bilateral intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Öznur Güney, Gazi University
- Investigators
- Öznur GÜNEY, Study chair, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554405
- Sponsor's protocol ID
- GaziU-GUNEY-001
- Status last verified
- Feb 2025
- First submitted
- 12 Aug 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Bilateral Neuromobilization in Patients With Carpal Tunnel Syndrome: Comparison Study With Unilateral Application
- ClinicalTrials.gov ID
- NCT06554405
- Acronym / sponsor ID
- GaziU-GUNEY-001
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Neuromobilization, Median Nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 15 Aug 2024 (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 study aims to investigate whether bilateral (both extremities together) neuromobilization is superior to unilateral (only the affected side) neuromobilization in individuals diagnosed with Carpal Tunnel Syndrome.
Detailed description
Carpal Tunnel Syndrome (CTS) is defined as an upper extremity nerve entrapment resulting from the compression of the median nerve at the wrist level. It is the most common entrapment neuropathy. Patients with CTS experience numbness, tingling, and pain in the hand, which can sometimes extend to the arm, along with hand weakness and thenar atrophy. These symptoms typically worsen after hand use and at night. While clinical findings are absent in the early stages of the disease, sensory and strength loss is observed in the areas innervated by the median nerve in advanced stages.
The pathophysiology of CTS includes hypertrophic changes in the synovial tissue of the flexor tendon, connective tissue changes in the median nerve, conduction disturbances, and increased pressure in the carpal tunnel.
Treatment is tailored to the patient's symptoms. Conservative treatment is preferred in mild to moderate stages, while surgical intervention may be necessary in advanced stages. All patients should receive education on ergonomics aimed at reducing symptoms in daily life.
Conservative treatment for CTS includes nerve mobilization techniques, the use of orthoses to maintain the wrist in a neutral position, electrotherapy (ESWT, laser), manual therapy, kinesiotaping, corticosteroid and platelet-rich plasma (PRP) injections, and anti-inflammatory medications. Patients who do not respond to conservative treatment are referred for surgery.
Neural structures are capable of tolerating significant tension and compression forces encountered during daily activities and sports. This capability is due to the connective tissue sheath surrounding the nerve.
The musculoskeletal system creates an environment that surrounds the nervous system, and its movements affect peripheral nerves. With the excursion (sliding) movement, compression on the peripheral nerve decreases. Clinical neuromobilization is a manual therapy method that integrates the mechanics and physiology of the nervous system with musculoskeletal function. Neuromobilization (NM) aims to balance the relationship between neural tissues and surrounding mechanical tissues, thereby regulating optimal physiological functions.
The aim of using neuromobilization exercises with sliding techniques in nerve entrapments is to increase axonal transport and improve nerve conduction. It has been suggested that these exercises can reduce pressure within the nerve, improve its blood supply, and thus contribute to nerve regeneration. Recent studies in the literature report that neuromobilization exercises have supportive effects in pain improvement, reduction of distal latency time, and increased pinch strength. A systematic review indicated these effects as pain improvement, lowering the pain threshold, improving function, and avoiding surgery. It was stated that neuromobilization exercises added to the CTS treatment program accelerate the rehabilitation process and enhance recovery.
Although there are studies in the literature proving the superiority of neuromobilization over other treatment methods, the number of studies investigating the application of neuromobilization to the unaffected side is limited. Considering that the connective tissue sheaths surrounding peripheral nerves in both upper extremities are connected via the central nervous system, it is hypothesized that neuromobilization applied to the unaffected side or bilaterally might be more effective on the symptomatic side compared to unilateral application. However, studies that consider this connection and include the unaffected side in treatment are significantly lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be grouped according to randomization into unilateral or bilateral intervention.
| Arm | Type | Receives |
|---|---|---|
| Unilateral Intervention | Active comparator | Other: Unilateral InterventionPatients will be treated for 4 weeks (2 days in a week, 8 sessions). The treatment plan involves massage therapy, neuromobilization exercises and cold application. In this arm, treatment plan will be applied only for the symptomatic side. The rest of the treatment will be the same as the other group. |
| Bilateral Intervention | Experimental | Other: Bilateral InterventionPatients will be treated for 4 weeks (2 days in a week, 8 sessions). The treatment plan involves massage therapy, neuromobilization exercises and cold application. In this arm, treatment plan will be applied only for both symptomatic and nonsymptomatic sides. The rest of the treatment will be the same as the other group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals diagnosed with CTS,
- Aged 18 and above,
- Without any other conditions in either upper extremity (such as trigger finger, osteoarthritis, tenosynovitis)
Key exclusion criteria (7 listed)
- Individuals with a history of surgery, trauma, or fracture in the same upper extremity,
- Those who have received an injection for CTS in the last 3 months,
- Those with poor cooperation,
- Those participating in any other treatment program during the study,
- Those with a history of uncontrolled systemic diseases or systemic diseases involved in the etiology of CTS (such as diabetes, thyroid diseases, rheumatoid arthritis),
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 |
|---|---|---|
| Unilateral InterventionTreatment plan will be applied to the symptomatic side. | Other | Unilateral Intervention |
| Bilateral InterventionTreatment plan will be applied to the symptomatic and nonsymptomatic sides. | Other | Bilateral Intervention |
Primary outcome
Symptom Severity Assessment (Boston Carpal Tunnel Syndrome Questionnaire- Symptom Severity Scale)
Time frame: Four weeks
The Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ), developed in 1993, will be used to assess individuals' functional status and symptoms. The Turkish validity and reliability study of the test has been conducted. The test consists of two self-assessment sections: one with 11 questions evaluating symptom severity and another with 8 questions evaluating functional capacity. It is a Likert-type questionnaire, where 1 indicates the best condition and 5 indicates the worst condition. The total score is calculated by dividing the total points by the number of questions, resulting in a score between 1 and 5.
5 secondary outcomes
Light Touch and Pressure Sense
Time frame: Four weeks
Visual Analog Scale (VAS)
Time frame: Four weeks
Gross Grip Strength
Time frame: Four weeks
Pinch Grip Strength
Time frame: Four weeks
Functional Level Assessment (Boston Carpal Tunnel Syndrome Questionnaire-Functional Status Scale)
Time frame: Four 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 24 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Öznur GÜNEY study chair
Zonguldak Bulent Ecevit 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 Unilateral Intervention and Bilateral Intervention in people with Carpal Tunnel Syndrome, run by Gazi 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 3 inclusion and 7 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 24 Dec 2025. 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?
Symptom Severity Assessment (Boston Carpal Tunnel Syndrome Questionnaire- Symptom Severity Scale) (time frame: Four weeks). 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 24 Dec 2025.