Bilateral vs. Unilateral Neuromobilization in Carpal Tunnel Syndrome

NCT ID: NCT06554405

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2025-06-20

Brief 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.

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

Keywords

Carpal Tunnel Syndrome; Neuromobilization; Median Nerve

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Unilateral Intervention

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.

Group Type: ACTIVE_COMPARATOR

Unilateral Intervention

Intervention Type: OTHER

Treatment plan will be applied to the symptomatic side.

Bilateral Intervention

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.

Group Type: EXPERIMENTAL

Bilateral Intervention

Intervention Type: OTHER

Treatment plan will be applied to the symptomatic and nonsymptomatic sides.

Interventions

Unilateral Intervention

Treatment plan will be applied to the symptomatic side.

Intervention Type: OTHER

Bilateral Intervention

Treatment plan will be applied to the symptomatic and nonsymptomatic sides.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Individuals diagnosed with CTS,
• Aged 18 and above,
• Without any other conditions in either upper extremity (such as trigger finger, osteoarthritis, tenosynovitis)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Öznur Güney

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Öznur GÜNEY

Role: STUDY_CHAIR

Zonguldak Bulent Ecevit University

Locations

Gazi University Faculty of Health Sciences

Ankara, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GaziU-GUNEY-001

Identifier Type: -

Identifier Source: org_study_id