Comparison of the Efficacy of Different Treatment Methods in Patients With Carpal Tunnel Syndrome

NCT ID: NCT05475808

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2025-05-27

Brief Summary

It is aimed to compare the effects of different conservative methods on the clinical condition of the patients, hand grip and pinch strengths and wrist muscle strengths in patients with carpal tunnel syndrome.

Detailed Description

Carpal tunnel syndrome (CTS) is one of the most common entrapment neuropathies. It occurs as a result of compression or irritation of the median nerve as it passes through the carpal tunnel in the wrist. It is seen in 1-4% of the general population.In nerve conduction studies, patients with mild and moderate CTS are treated with conservative treatment methods, while patients with severe nerve conduction findings and thenar atrophy are treated surgically.Although there are many methods used in the conservative treatment of carpal tunnel syndrome, there is no definite data about which treatment option to choose.The most commonly used conservative method is the wrist rest splint application, which is based on the principle of resting the wrist.In addition, there are tendon and nerve gliding exercises that facilitate nerve and tendon movements. Physical therapy agents such as Tens, Laser and Ultrasound can be used in the treatment of CTS. Non-Steroidal anti-inflammatory drugs and B6 vitamins can be used as drug therapy. Apart from these, local corticosteroid injections can be applied from the wrist.

There are studies comparing conservative treatment methods in carpal tunnel syndrome. However, these are generally in the form of studies that measure and compare the effects of treatments on the clinical condition of their patients and on hand grip and finger pinch strength. There is no comparative study investigating the effects of conservative treatment methods on wrist muscle strength in patients with carpal tunnel syndrome.

It was observed that wrist muscle strength decreased in patients with CTS compared to normal patients. Wrist muscle strength is important in hand and wrist functions as well as hand grip and pinch strength are important.

Flexion-extension, radial-ulnar deviation and supination-pronation muscle strengths of the patients' wrists can be measured with an isokinetic dynamometer device.

It is aimed to compare the effects of different conservative methods on the clinical condition of the patients, hand grip and pinch strengths and wrist muscle strengths in patients with carpal tunnel syndrome.

It will be organized as a prospective randomized study. It is planned to include 60 patients in the study. Patients will be randomized into three groups in equal numbers, stratified by age and sex.

Patients in Group 1 will be applied to only static wrist splint treatment for 8 week.

Patients in Group 2 will be applied to tendon and nerve gliding exercises for the wrist in addition to static wrist splint treatment for 8 week .

Patients in Group 3 will be applied to local steroid injection the wrist in addition to static wrist splint treatment for 8 week.

Demographic data, medical history, dominant and CTS hand information will be recorded at the beginning of the patients.

Patients in both groups will be evaluated before the treatment, at the 8th week after treatment.

Conditions

Carpal Tunnel Syndrome

Study Design

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

Study Groups

Splint

Patients in Group 1 will be applied to only static wrist splint treatment for 8 week.

Group Type: ACTIVE_COMPARATOR

Static wrist splint treatment

Intervention Type: DEVICE

Static wrist splint (volar wrist cock-up orthosis): It extends from the proximal of the metacarpophalangeal (MCP) joint to the distal 2/3 of the forearm, supports the wrist from the volar face. It stabilizes the wrist in 20-30 degrees of dorsiflexion and restricts wrist movements. It allows movement of the MCP joints. Patients will be asked to wear this splint continuously at night and for at least 4 hours during the day for 8 weeks.

Tendon and nerve gliding exercise

Patients in Group 2 will be applied to tendon and nerve gliding exercises for the wrist in addition to static wrist splint treatment for 8 week.

Group Type: ACTIVE_COMPARATOR

Static wrist splint treatment

Intervention Type: DEVICE

Static wrist splint (volar wrist cock-up orthosis): It extends from the proximal of the metacarpophalangeal (MCP) joint to the distal 2/3 of the forearm, supports the wrist from the volar face. It stabilizes the wrist in 20-30 degrees of dorsiflexion and restricts wrist movements. It allows movement of the MCP joints. Patients will be asked to wear this splint continuously at night and for at least 4 hours during the day for 8 weeks.

Tendon and nerve gliding exercises

Intervention Type: OTHER

Tendon and nerve gliding exercises will be applied 5 sessions a day for 8 weeks. Each session will hold 10 repetitions and approximately 7 seconds in each exercise position.

These exercises involve a sequence of finger movements (for tendon gliding) and wrist and fingers movements (for median nerve gliding).

local steroid injection

Patients in Group 3 will be applied to local steroid injection to wrist in addition to static wrist splint treatment for 8 week.

Group Type: ACTIVE_COMPARATOR

Static wrist splint treatment

Intervention Type: DEVICE

Static wrist splint (volar wrist cock-up orthosis): It extends from the proximal of the metacarpophalangeal (MCP) joint to the distal 2/3 of the forearm, supports the wrist from the volar face. It stabilizes the wrist in 20-30 degrees of dorsiflexion and restricts wrist movements. It allows movement of the MCP joints. Patients will be asked to wear this splint continuously at night and for at least 4 hours during the day for 8 weeks.

Wrist local steroid injection

Intervention Type: DRUG

Wrist local steroid injection:

After proper area cleaning with povidone solution, 1ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml) steroid injection will be applied around the median nerve with a 22 G injector from ulnar side of the wrist proximal crease under ultrasound guidance.

Interventions

Static wrist splint treatment

Static wrist splint (volar wrist cock-up orthosis): It extends from the proximal of the metacarpophalangeal (MCP) joint to the distal 2/3 of the forearm, supports the wrist from the volar face. It stabilizes the wrist in 20-30 degrees of dorsiflexion and restricts wrist movements. It allows movement of the MCP joints. Patients will be asked to wear this splint continuously at night and for at least 4 hours during the day for 8 weeks.

Intervention Type: DEVICE

Tendon and nerve gliding exercises

Tendon and nerve gliding exercises will be applied 5 sessions a day for 8 weeks. Each session will hold 10 repetitions and approximately 7 seconds in each exercise position.

These exercises involve a sequence of finger movements (for tendon gliding) and wrist and fingers movements (for median nerve gliding).

Intervention Type: OTHER

Wrist local steroid injection

Wrist local steroid injection:

After proper area cleaning with povidone solution, 1ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml) steroid injection will be applied around the median nerve with a 22 G injector from ulnar side of the wrist proximal crease under ultrasound guidance.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with mild to moderate CTS confirmed by Electromyography
• Clinically, at least one of the symptoms of hand-wrist pain, numbness, night pain should be present.
• Clinically, at least one of the Tinel, Phalen, and median nerve compression findings should be present.

Exclusion Criteria

• Having a history of trauma and operation on the wrist.
• Patients who have had previous injections from the wrist
• Patients with thyroid diseases, diabetes mellitus, systemic peripheral neuropathy and cervical radiculopathy
• Pregnant patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Serdar Kilinc

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Abant Izzet Baysal University

Bolu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AIBU-FTR-SK-02

Identifier Type: -

Identifier Source: org_study_id