Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-25 @ 4:20 AM
NCT ID:
NCT06725420
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Presence of typical CTS symptoms (numbness, tingling, paresthesias, or pain that may be provoked by nighttime or activity-related posture
* VAS score of ≥ 3/10
* Symptom duration longer than 12 weeks
* Positive Tinel's and/or Phalen's sign
* Electrophysiologically mild or moderate CTS being diagnosed.
* Volunteer to participate in study
Exclusion Criteria:
* Patients with shoulder, elbow, wrist, or finger problems (e.g., impingement syndrome, epicondylitis, history of fractures in the wrist, de Quervain's tenosynovitis, trigger finger, Complex Regional Pain Syndrome (CRPS), Dupuytren's contracture).
* Patients with a history of trauma or surgery in the affected hand, or those with significant anatomical deformities.
* Patients with systemic diseases such as rheumatological disorders, hypothyroidism, amyloidosis, diabetes, gout, or chronic kidney failure.
* Patients with conditions that may mimic CTS, such as polyneuropathy, plexopathy, cervical radiculopathy, or thoracic outlet syndrome.
* Patients with cognitive dysfunction or communication issues.
* Patients with severe CTS, neurological deficits (e.g., thenar atrophy, muscle weakness in thumb abduction/opposition), or those requiring surgical intervention.
* Patients who have received local steroid injections or physical therapy to the hand/wrist within the last 6 months.
* Patients who are receiving or will receive another/additional treatment for CTS.
* Pregnant or lactating women.
* Patients with active malignancies or local/systemic infections.
* Patients who are receiving any active treatment (e.g., NSAIDs, oral/intramuscular steroids, acupuncture, other pain medications).
* Patients with upper extremity involvement due to first motor neuron damage (e.g., stroke-hemiplegia, tetraparesis, multiple sclerosis).
* Patients with a bifid median nerve, persistent median artery, ganglion cyst, tenosynovitis, or tendinitis in the wrist.
* Use of a wrist splint during the last 6 months.
* Allergy to corticosteroids or local anesthetics, and blood diathesis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06725420
Study Brief:
Protocol Section:
NCT06725420