Comparison of the Efficacy of Different Treatment Methods in Patients With Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Active
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Static wrist splint treatment
Tendon and nerve gliding exercises
Wrist local steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
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
Sites / Locations
- Abant Izzet Baysal University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Splint
Tendon and nerve gliding exercise
local steroid injection
Arm Description
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 to wrist in addition to static wrist splint treatment for 8 week.
Outcomes
Primary Outcome Measures
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05475808
First Posted
July 25, 2022
Last Updated
October 12, 2023
Sponsor
Abant Izzet Baysal University
1. Study Identification
Unique Protocol Identification Number
NCT05475808
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Splint
Arm Type
Active Comparator
Arm Description
Patients in Group 1 will be applied to only static wrist splint treatment for 8 week.
Arm Title
Tendon and nerve gliding exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
local steroid injection
Arm Type
Active Comparator
Arm Description
Patients in Group 3 will be applied to local steroid injection to wrist in addition to static wrist splint treatment for 8 week.
Intervention Type
Device
Intervention Name(s)
Static wrist splint treatment
Intervention Description
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
Other
Intervention Name(s)
Tendon and nerve gliding exercises
Intervention Description
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
Drug
Intervention Name(s)
Wrist local steroid injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Time Frame
Before Treatment
Title
Visual Analogue Scale
Description
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Time Frame
8 week after treatment
Title
Isokinetic Muscle Strength Measure
Description
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.
Time Frame
Before Treatment
Title
Isokinetic Muscle Strength Measure
Description
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.
Time Frame
8 week after treatment
Title
The hand grip strength
Description
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.
Time Frame
Before Treatment
Title
The hand grip strength
Description
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.
Time Frame
8 week after treatment
Title
The finger pinch strength
Description
Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.
Time Frame
Before Treatment
Title
The finger pinch strength
Description
Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.
Time Frame
8 week after treatment
Title
Boston Carpal Tunnel Syndrome Questionnaire
Description
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.
Time Frame
Before Treatment
Title
Boston Carpal Tunnel Syndrome Questionnaire
Description
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.
Time Frame
8 week after treatment
Secondary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder end Hand Questionnaire
Description
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.
Time Frame
Before Treatment
Title
Disabilities of the Arm, Shoulder end Hand Questionnaire
Description
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.
Time Frame
8 week after treatment
Title
Short Form-36 Quality of Life Scale
Description
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.
Time Frame
Before Treatment
Title
Short Form-36 Quality of Life Scale
Description
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.
Time Frame
8 week after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Abant Izzet Baysal University
City
Bolu
ZIP/Postal Code
14100
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Efficacy of Different Treatment Methods in Patients With Carpal Tunnel Syndrome
We'll reach out to this number within 24 hrs