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Effect of Out of Plane and In Plane Injection Techniques in Patients With Carpal Tunnel Syndrome

I

Istanbul University - Cerrahpasa (IUC)

Status

Completed

Conditions

Carpal Tunnel Syndrome
Pain
Carpal Tunnel

Treatments

Other: Technique of injection method

Study type

Interventional

Funder types

Other

Identifiers

NCT05343351
25.03.2022/109

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups

Out of Plane arm
Experimental group
Description:
The patient group who was injected using the ultrasound-guided out of plane injection method.
Treatment:
Other: Technique of injection method
In Plane arm
Experimental group
Description:
The group of patients who were injected using the ultrasound-guided in-plane injection method.
Treatment:
Other: Technique of injection method

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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