Effect of Out of Plane and In Plane Injection Techniques in Patients With Carpal Tunnel Syndrome
NCT ID: NCT05343351
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2022-04-01
2023-02-21
Brief Summary
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1. To evaluate the patients in terms of the pain they feel during the application of carpal tunnel syndrome (CTS) injection,
2. Evaluation in terms of undesirable effects developing after injection,
3. To evaluate the degree of pain/drowsiness, symptom severity and functionality, and median nerve diameter at the end of the first month after the injection, and to evaluate the relationship of these parameters with the pain felt by the patients during the injection.
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Detailed Description
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One group will be injected using the out-of-plane technique under ultrasound, and the other group will be injected using the in-plane technique. Patients will be evaluated before the treatment, at the 1st hour after the injection and at the end of the 4th week after the injection.
Randomization and injection of the patients will be done by Dr Gül Tuğba Bulut, while the evaluation of the patients and the sonographic evaluation of the median nerve will be done by Dr Alper Mengi.
Age, gender, education level, body mass index, duration of symptoms, dominant hand, injection hand, and carpal tunnel syndrome severity detected in EMG of the patients included in the study will be recorded.
The patients will be questioned about the pain they feel during the injection at the end of the 1st hour after the injection, while the degree of pain/numbness in the wrist and finger, symptom severity and functionality, and median nerve diameter are evaluated at the end of the 4th week before and after the injection.
Patients will be questioned about undesirable effects at the end of the 4th week after the injection.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Out of Plane arm
The patient group who was injected using the ultrasound-guided out of plane injection method.
Technique of injection method
In 'out of plane group', the ultrasound probe will be placed at the entrance level of the proximal carpal tunnel (scaphoid-pisiform plane), the ulnar edge of the median nerve will be taken to the midpoint of the probe, and then the needle will be inserted from the middle point of the probe with the out of plane method. Then the needle will be advanced towards the ulnar side of the median nerve and the injection content will be given into the tunnel.
In 'in plane group group', the ultrasound probe will be placed at the proximal carpal tunnel entrance level (scaphoid-pisiform plane), it will be entered at a cross angle between the ulnar artery and the median nerve with the in-plane method, and be advanced under the median nerve, and then the injection content will be given into the carpal tunnel.
In Plane arm
The group of patients who were injected using the ultrasound-guided in-plane injection method.
Technique of injection method
In 'out of plane group', the ultrasound probe will be placed at the entrance level of the proximal carpal tunnel (scaphoid-pisiform plane), the ulnar edge of the median nerve will be taken to the midpoint of the probe, and then the needle will be inserted from the middle point of the probe with the out of plane method. Then the needle will be advanced towards the ulnar side of the median nerve and the injection content will be given into the tunnel.
In 'in plane group group', the ultrasound probe will be placed at the proximal carpal tunnel entrance level (scaphoid-pisiform plane), it will be entered at a cross angle between the ulnar artery and the median nerve with the in-plane method, and be advanced under the median nerve, and then the injection content will be given into the carpal tunnel.
Interventions
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Technique of injection method
In 'out of plane group', the ultrasound probe will be placed at the entrance level of the proximal carpal tunnel (scaphoid-pisiform plane), the ulnar edge of the median nerve will be taken to the midpoint of the probe, and then the needle will be inserted from the middle point of the probe with the out of plane method. Then the needle will be advanced towards the ulnar side of the median nerve and the injection content will be given into the tunnel.
In 'in plane group group', the ultrasound probe will be placed at the proximal carpal tunnel entrance level (scaphoid-pisiform plane), it will be entered at a cross angle between the ulnar artery and the median nerve with the in-plane method, and be advanced under the median nerve, and then the injection content will be given into the carpal tunnel.
Eligibility Criteria
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Inclusion Criteria
* Numbness and tingling in the median nerve innervation area with or without pain
* Worsening of symptoms at night
* Positive Tinel and/or Phalen sign
* Symptom duration longer than 12 weeks
* Electrophysiologically mild or moderate CTS being diagnosed.
Exclusion Criteria
* Presence of multiple entrapment neuropathy
* Weakness in hand thumb abduction or opposition
* Thenar atrophy
* Presence of wrist corticosteroid and/or local anesthetic injection
* Regular use of medical treatment such as oral corticosteroids or NSAIDs
* Having entered a physical therapy program due to CTS in the last 6 months before the injection
* A history of trauma or arthritis attack at the wrist level
* Previous surgery due to CTS
* Thyroid diseases, diabetes, chronic kidney failure
* Having bifid median nerve, persistent median artery, ganglion cyst, tenosynovitis or tendinitis on wrist USG
* Rheumatological disease (rheumatoid arthritis, ankylosing spondylitis, systemic lupus) erythematosus, vasculitis, systemic sclerosis, dermatomyositis)
* Presence of malignancy
* Pregnant or breastfeeding mothers
* Infection or skin lesion at the injection site
* Use of wrist splints in the last 4 weeks
* Allergy to corticosteroids or local anesthetics
18 Years
ALL
No
Sponsors
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Istanbul Training and Research Hospital
OTHER_GOV
Istanbul University - Cerrahpasa
OTHER
Responsible Party
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Alper mengi
Medical Doctor
Locations
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Istanbul Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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25.03.2022/109
Identifier Type: -
Identifier Source: org_study_id
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