Actively Recruiting

Phase Not Applicable
Age: 20Years - 60Years
All Genders
ID06133712

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

Led by Tanta University · Updated on 2025-05-29

135

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing the pain relief effects of three types of local injections—Dexmedetomidine, Ozone, and Dexamethasone—in people with carpal tunnel syndrome (CTS). CTS is caused by pressure on the median nerve at the wrist, leading to symptoms like numbness and pain. While corticosteroid injections are commonly used to reduce inflammation in mild to moderate CTS, there is no clear guideline on which steroid is best. This study aims to evaluate which injection offers better long-term pain relief and functional improvement in CTS patients. Participants receive one of three treatments: an injection of Dexmedetomidine (1 microgram/kg) combined with lidocaine near the median nerve; a single local injection of ozone gas mixed with lidocaine; or a single injection of dexamethasone with lidocaine. These injections are administered using similar techniques targeting the wrist area. The study follows a randomized, double-blind design to fairly compare these three treatment options. During the trial, patients will be assessed before treatment and then at 1 week, 4 weeks, 12 weeks, and 24 weeks after injection. Assessments include measuring pain levels and functional status, as well as nerve conduction studies to evaluate median nerve function. Researchers will also track pain medication use during the first 48 hours after injection. The study is sponsored by Tanta University and includes adults aged 20 to 60 with mild to moderate CTS confirmed by ultrasound and nerve studies.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age from 20 to 60 years.
  • Any gender.
  • Diagnosed with mild-to-moderate carpal tunnel syndrome confirmed by ultrasound.
  • Symptoms of numbness and pain in the median nerve area lasting at least 3 months.
  • Nerve conduction studies consistent with carpal tunnel syndrome as per guidelines.
  • Median nerve cross-sectional area at the wrist greater than 12 mm2 indicating mild-to-moderate CTS.
Not Eligible

You will not qualify if you...

  • Patient refusal to participate.
  • Severe symptoms of carpal tunnel syndrome indicating surgery.
  • Improvement with medical treatment.
  • Previous surgery or injections for carpal tunnel syndrome.
  • Pregnancy.
  • Coexisting brachial plexopathy, thoracic outlet syndrome, polyneuropathy, radiculopathy, or other peripheral nerve lesions in the upper limb.
  • Severe cardiovascular disease.
  • Morbid obesity with BMI over 35 kg/m2.
  • Infection at the injection site.
  • Bleeding disorders.
  • History of thyroid deficiency, uncontrolled diabetes, rheumatoid arthritis, or glucose-6-phosphate dehydrogenase deficiency.
  • Allergy to Ozone or Dexmedetomidine.
  • End-stage kidney or liver disease.
  • History of inflammatory joint or connective tissue disorders, burns, local tissue contractures, or wrist trauma.
  • Unwillingness to complete pain scale or nerve conduction studies before and after injection.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day

Participants receive a single local injection of either Dexmedetomidine, Ozone, or Dexamethasone near the median nerve for carpal tunnel syndrome pain relief.

1 treatment visit (in-person)

Follow-up

Duration - 24 weeks

Participants are assessed for pain relief and functional status improvement at multiple timepoints after the injection.

Visits at 1 week, 4 weeks, 12 weeks, and 24 weeks after injection

Trial Site Locations

Total: 1 location

1

Faculty of Medicine

Tanta, El Gharbia, Egypt, 31527

Actively Recruiting

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Research Team

M

Mahmoud T Elgebaly, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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