Clinical trial NCT06554405: Bilateral Vs. Unilateral Neuromobilization in Carpal Tunnel Syndrome
Official title: Examining the Effects of Bilateral Neuromobilization in Patients with Carpal Tunnel Syndrome: Comparison Study with Unilateral Application
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Neuromobilization
Median Nerve
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be grouped according to randomization into unilateral or bilateral intervention.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Four weeks
Secondary outcomes:
measure: Light Touch and Pressure Sense
timeFrame: Four weeks
measure: Gross Grip Strength
timeFrame: Four weeks
measure: Pinch Grip Strength
timeFrame: Four weeks
measure: Functional Level and Disease Severity Assessment (Boston Carpal Tunnel Syndrome Questionnaire)
timeFrame: Four weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences
Study officials:
affiliation: Zonguldak Bulent Ecevit University
name: Öznur GÜNEY
role: STUDY_CHAIR
References: