Clinical trial NCT05343351: Effect of Out of Plane and In Plane Injection Techniques in Patients With Carpal Tunnel Syndrome
Official title: The Effect of Out of Plane and In Plane Injection Techniques on Injection Pain and Functionality in Patients With Carpal Tunnel Syndrome Undergoing Ultrasound-Guided Injection: A Randomized, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Pain
Carpal Tunnel
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Istanbul Training and Research Hospital
First posted: 2022-04-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study, using two different injection techniques,

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.

Detailed description: Among the evaluated patients, the patients who met the inclusion and exclusion criteria and accepted the carpal tunnel syndrome injection will be randomized into 2 groups using the random numbers table.

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥18
* 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 conditions such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome that may mimic CTS
* 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

Primary outcomes:
measure: Assessment of pain during injection
timeFrame: 1 hour
measure: Pain/Numbness Evaluation
timeFrame: 3 days
measure: Evaluation of symptom severity and functionality
timeFrame: 3 days
measure: Evaluation of undesirable effects
timeFrame: 1 day
measure: Sonographic evaluation of the median nerve
timeFrame: 1 day
measure: Descriptive information
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
Study officials:
References: