Clinical trial NCT06133712: Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Pain Relief
Official title: A Comparative Study Between Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Long- Term Pain Relief
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel
Dexmedetomidine
Ozone
Dexamethasone
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 135
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the analgesic efficacy of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome.

Detailed description: Carpal tunnel syndrome (CTS) is a collection of symptoms and signs associated with median neuropathy at the carpal tunnel. Most CTS is related to idiopathic compression of the median nerve as it travels through the wrist at the carpal tunnel.

Corticosteroid injection is an extensively used and accepted treatment in mild to moderate CTS according to the guidelines of the American Academy of Orthopedic Surgeons as corticosteroids reduce the inflammation and edema associated with CTS. However, there is no guideline as to which corticosteroid has to be used as the standard treatment in CTS.

Triamcinolone acetonide, a commonly used steroid for this indication, is a particulate steroid, which can cause permanent nerve injury if accidentally injected into the nerve.

Local ozone injection as a therapeutic option in some musculoskeletal conditions; ozone (O3) gas is a molecule consisting of three oxygen atoms in a dynamically unstable structure. Ozone therapy has been utilized and studied for more than a century.

Eligibility criteria: Inclusion Criteria:

* Age from 20 to 60 years.
* Both sexes.
* Patients with ultrasonographic evidence of mild-to-moderate carpal tunnel syndrome (CTS).
* Inclusion criteria will include numbness and pain in the median nerve (MN) distribution persisting for minimum of 3 months , nerve conduction studies (NCS) consistent with carpal tunnel syndrome (CTS) as per the American Association of Neuromuscular and Electro diagnostic Medicine (AANEM) guidelines, and an median nerve (MN) cross-sectional area (CSA)at the wrist \>12 mm2 suggesting mild-to-moderate CTS forms.

Exclusion Criteria:

* Patient refusal.
* Patients with severe symptoms and signs of CTS as identified per the American Association of Neuromuscular and Electro diagnostic Medicine (AANEM) guidelines,\[14\] as this is an indication for surgery,
* Patients who show improvement on medical treatment,
* Previous surgical or injectional CTS treatment,
* Pregnancy ,co existence of brachial plexopathy, or thoracic outlet syndrome, polyneuropathy, radiculopathy and peripheral nerve lesion in upper limb.
* Severe cardiovascular disease
* Morbid obese patients (body mass index (BMI) of \>35 kg/m2)
* Infection at site of injection.
* Bleeding diathesis.
* History of thyroid deficiency, uncontrolled diabetes mellitus , rheumatoid arthritis and history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
* History of Ozone or Dexmedetomidine allergy.
* End stage renal and hepatic disease.
* History of inflammatory joint , connective tissue disorders, , burns, any local tissue contractures and history of wrist trauma.
* Patients who will not consent to completing The visual analogue scale (VAS) for pain or nerve conduction study before and after injection.

Primary outcomes:
measure: The analgesic efficacy and functional status improvement of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome
timeFrame: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
Secondary outcomes:
measure: Median motor nerve conduction study(NCS) evaluation
timeFrame: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
measure: Sensory nerve conduction study(NCS) evaluation
timeFrame: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
measure: Analgesic requirement
timeFrame: First 48 hours post injection .
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine
state: El Gharbia
Study officials:
affiliation: Tanta faculty of medicine
name: MAHMOUD ELGEBALY, MD
role: PRINCIPAL_INVESTIGATOR
References: