Clinical trial NCT05475808: Comparison of the Efficacy of Different Treatment Methods in Patients With Carpal Tunnel Syndrome
Official title: Comparison of the Efficacy of Different Treatment Methods in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Before Treatment
measure: Visual Analogue Scale
timeFrame: 8 week after treatment
measure: Isokinetic Muscle Strength Measure
timeFrame: Before Treatment
measure: Isokinetic Muscle Strength Measure
timeFrame: 8 week after treatment
measure: The hand grip strength
timeFrame: Before Treatment
measure: The hand grip strength
timeFrame: 8 week after treatment
measure: The finger pinch strength
timeFrame: Before Treatment
measure: The finger pinch strength
timeFrame: 8 week after treatment
measure: Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: Before Treatment
measure: Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: 8 week after treatment
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder end Hand Questionnaire
timeFrame: Before Treatment
measure: Disabilities of the Arm, Shoulder end Hand Questionnaire
timeFrame: 8 week after treatment
measure: Short Form-36 Quality of Life Scale
timeFrame: Before Treatment
measure: Short Form-36 Quality of Life Scale
timeFrame: 8 week after treatment
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
Study officials:
References: