Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Pain Relief

Last updated: November 18, 2024
Sponsor: Tanta University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carpal Tunnel Syndrome

Treatment

Dexamethasone

Ozone

Dexmedetomidine

Clinical Study ID

NCT06133712
36226/12/22
  • Ages 20-60
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 ofNeuromuscular and Electro diagnostic Medicine (AANEM) guidelines, and an mediannerve (MN) cross-sectional area (CSA)at the wrist >12 mm2 suggestingmild-to-moderate CTS forms.

Exclusion

Exclusion Criteria:

  • Patient refusal.

  • Patients with severe symptoms and signs of CTS as identified per the AmericanAssociation 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 arthritisand 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 localtissue contractures and history of wrist trauma.

  • Patients who will not consent to completing The visual analogue scale (VAS) for painor nerve conduction study before and after injection.

Study Design

Total Participants: 135
Treatment Group(s): 3
Primary Treatment: Dexamethasone
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • Faculty of Medicine

    Tanta, El Gharbia 31527
    Egypt

    Active - Recruiting

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