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

May 22, 2025 updated by: Mahmoud T Elgebaly,MD, Tanta University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El Gharbia
      • Tanta, El Gharbia, Egypt, 31527
        • Recruiting
        • Faculty of medicine
        • Sub-Investigator:
          • Ayman A Yousef, MD
        • Sub-Investigator:
          • Alaa M Abo Hagar, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ashraf A Abo Elsafa, MD
        • Sub-Investigator:
          • Ahmed E Salim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine
Patients will receive injection of 1 microgram/kg dexmedetomidine average (70-100-microgram) (0.7-1ml) plus 4ml lidocaine injection nearby median nerve
Drug: Dexmedetomidine
Patients will receive injection of 1 microgram/kg dexmedetomidine average (70-100-microgram) (0.7-1ml) plus 4ml lidocaine injection nearby median nerve.
Other Names:
  • Precedex®
Active Comparator: Dexamethasone
Patients will receive a single local injection of 5 mL (3 mL lidocaine (1%) and 2 mL [8 mg] dexamethasone) via the same technique.
Drug: Dexamethasone
Patients will receive a single local injection of 5 mL (3 mL lidocaine (1%) and 2 mL [8 mg] dexamethasone) via the same technique.
Other Names:
  • Decadron
Active Comparator: Ozone
Participants will receive a single local injection of 4 ml ozone (10 micrograms/ml) plus to 1 ml lidocaine (1%) using a 25 G needle.
Drug: Ozone
Participants will receive a single local injection of 4 ml ozone (10 micrograms/ml) plus to 1 ml lidocaine (1%) using a 25 G needle.
Other Names:
  • PubChem CID 24823

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The analgesic efficacy and functional status improvement of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome
Time Frame: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date

The analgesic efficacy and functional status improvement of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome via assessment of Visual Analogue Scale (VAS) before and after injection.

VAS used as an effective tool to detect intensity of pain will be recorded (0 to10) "0" represents no pain ,"10" worst pain, "1-3" mild pain,"4-6 " moderate pain and" 7-10 " severe pain.

Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24 weeks intervals after injection.
Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median motor nerve conduction study(NCS) evaluation
Time Frame: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
Each patient will be assessed regarding electrophysiological changes sensory nerve conduction velocity in millimeter/seconds and distal motor latency in milliseconds at the baseline (before injection), at 1week, 4weeks, 12 weeks and 24 weeks intervals after injection.
Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
Sensory nerve conduction study(NCS) evaluation
Time Frame: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
Each patient will be assessed regarding electrophysiological changes sensory nerve conduction velocity in millimeter/seconds and distal motor latency in milliseconds at the baseline (before injection), at 1week, 4weeks, 12weeks, and 24 weeks intervals after injection.
Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
Analgesic requirement
Time Frame: First 48 hours post injection .
Analgesic requirement ( dose and frequency of oral acetaminophen intake in first 48 hours) for post injection .
First 48 hours post injection .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: MAHMOUD ELGEBALY, MD, Tanta faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36226/12/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dexmedetomidine

Clinical Trials on Dexmedetomidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe