Pain relief for carpal tunnel syndrome using Dexmedetomidine, Ozone, and Dexamethasone injections

A Comparative Study Between Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Long- Term Pain Relief

This study is testing a new combination of injections to see if it can relieve pain better for people with carpal tunnel syndrome compared to standard treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 20 Years to 60 Years
• Sex: All
• Sponsor: Tanta University (Academic / other)
• Locations: 1 site (Tanta, El Gharbia)
• Trial ID: NCT06133712 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a combination of Dexmedetomidine, Ozone, and Dexamethasone injections for pain relief in patients with carpal tunnel syndrome (CTS). CTS is characterized by symptoms related to median nerve compression at the wrist, and current treatments often involve corticosteroid injections. The study will include patients aged 20 to 60 with mild-to-moderate CTS, confirmed by ultrasound and nerve conduction studies. The goal is to determine if this novel combination therapy provides better analgesic outcomes compared to standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 60 with mild-to-moderate carpal tunnel syndrome symptoms persisting for at least three months.

Not a fit: Patients with severe carpal tunnel syndrome or those who have previously undergone surgery or injections for CTS may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a more effective pain relief option for patients suffering from carpal tunnel syndrome.

How similar studies have performed: While corticosteroid injections are a standard treatment for CTS, the combination of Dexmedetomidine and Ozone is a novel approach that has not been widely tested in similar studies.

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.

Where this trial is running

Tanta, El Gharbia

• Faculty of Medicine — Tanta, El Gharbia, Egypt (Recruiting)

Study contacts

• Principal investigator: Mahmoud Elgebaly, Md — Tanta faculty of medicine
• Study coordinator: Mahmoud T Elgebaly, MD

Conditions Carpal Tunnel; Dexmedetomidine; Ozone; Dexamethasone