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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05475808
• Other study ID #: AIBU-FTR-SK-02
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 1, 2022
• Est. completion date: February 27, 2024

Study information

• Verified date: January 2024
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 27, 2024
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• 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.

Other:
• 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).

Drug:
• 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.

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal University	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).	Before Treatment
Primary	Visual Analogue Scale	Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).	8 week after treatment
Primary	Isokinetic Muscle Strength Measure	Wrist flexion/extension, radial/ulnar deviation, supination/pronation strengths at 60° and 210°/s will be evaluated with an isokinetic test and exercise system (CSMI Cybex). Patients will be seated on the test chair with the backrest set to 90°. The arm to be tested will be secured to the chair's forearm rest. The wrist joint will be positioned in neutral. The forearm stabilizer pad and strap will secure the distal aspect of the forearm of the test hand. Wrist flexion/extension range of motion, radial/ulnar deviation range of motion, supination/pronation range of motion will be set within each patients' available range. Patients will be permitted 4 experimental trials to become familiar with the process for each angular velocity, and then they will perform 5 maximal repetitions at 60°/s and 12 maximal repetitions at 210°/s. At the end of the test, muscle strength (Peak Torque) will be measured in Newton meters.	Before Treatment
Primary	Isokinetic Muscle Strength Measure	Wrist flexion/extension, radial/ulnar deviation, supination/pronation strengths at 60° and 210°/s will be evaluated with an isokinetic test and exercise system (CSMI Cybex). Patients will be seated on the test chair with the backrest set to 90°. The arm to be tested will be secured to the chair's forearm rest. The wrist joint will be positioned in neutral. The forearm stabilizer pad and strap will secure the distal aspect of the forearm of the test hand. Wrist flexion/extension range of motion, radial/ulnar deviation range of motion, supination/pronation range of motion will be set within each patients' available range. Patients will be permitted 4 experimental trials to become familiar with the process for each angular velocity, and then they will perform 5 maximal repetitions at 60°/s and 12 maximal repetitions at 210°/s. At the end of the test, muscle strength (Peak Torque) will be measured in Newton meters.	8 week after treatment
Primary	The hand grip strength	The hand grip strength of the patients will be measured with a North Coast hydraulic hand dynamometer. The average of 3 different repetitive measurements will be taken.	Before Treatment
Primary	The hand grip strength	The hand grip strength of the patients will be measured with a North Coast hydraulic hand dynamometer. The average of 3 different repetitive measurements will be taken.	8 week after treatment
Primary	The finger pinch strength	Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.	Before Treatment
Primary	The finger pinch strength	Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.	8 week after treatment
Primary	Boston Carpal Tunnel Syndrome Questionnaire	This questionnaire consists of two parts: Boston Symptom Severity Scale (BSSS) and Boston Functional Capacity Scale (BFCS). BSSS consists of 11 questions, and BFCS consists of 8 questions. The score of each question varies between 1-5. High scores indicate severe symptoms and reduced functional capacity.	Before Treatment
Primary	Boston Carpal Tunnel Syndrome Questionnaire	This questionnaire consists of two parts: Boston Symptom Severity Scale (BSSS) and Boston Functional Capacity Scale (BFCS). BSSS consists of 11 questions, and BFCS consists of 8 questions. The score of each question varies between 1-5. High scores indicate severe symptoms and reduced functional capacity.	8 week after treatment
Secondary	Disabilities of the Arm, Shoulder end Hand Questionnaire	The Disabilities of the Arm, Shoulder end Hand Questionnaire (DASH) consists of 3 parts: the functional/symptom model, the business model, and the sports/musicians model. The individual fills himself. In this study, functional/symptom and business model sections will be used. A score between 0-100 is obtained from each section. High score increases handicap.	Before Treatment
Secondary	Disabilities of the Arm, Shoulder end Hand Questionnaire	The Disabilities of the Arm, Shoulder end Hand Questionnaire (DASH) consists of 3 parts: the functional/symptom model, the business model, and the sports/musicians model. The individual fills himself. In this study, functional/symptom and business model sections will be used. A score between 0-100 is obtained from each section. High score increases handicap.	8 week after treatment
Secondary	Short Form-36 Quality of Life Scale	The patients' quality of life will be evaluated with the Short Form-36 Quality of Life Scale. It consists of 36 questions filled by the individual himself. High scores indicate good quality of life.	Before Treatment
Secondary	Short Form-36 Quality of Life Scale	The patients' quality of life will be evaluated with the Short Form-36 Quality of Life Scale. It consists of 36 questions filled by the individual himself. High scores indicate good quality of life.	8 week after treatment