- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07498998
Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome
A Comparative Study Between Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome
Study Overview
Status
Conditions
Detailed Description
Carpal Tunnel Syndrome is one of the most common peripheral entrapment neuropathies caused by compression of the median nerve within the carpal tunnel. This condition manifests as pain, numbness, tingling, and weakness, primarily in the thumb, index, and middle fingers. The condition significantly impairs daily activities and diminishes the quality of life, often prompting patients to seek medical interventions .
The pathophysiology of Carpal Tunnel Syndrome involves increased pressure within the carpal tunnel, leading to ischemia and dysfunction of the median nerve. Risk factors include repetitive wrist motions, systemic diseases like diabetes and rheumatoid arthritis, obesity, and hormonal changes during pregnancy .Early identification and treatment are essential to prevent irreversible nerve damage and functional impairment .
Traditional management strategies for Carpal Tunnel Syndrome vary depending on the severity of symptoms. Conservative approaches, including wrist splinting, activity modification, and physical therapy, are typically recommended for mild to moderate cases . However, these methods often provide limited relief, and invasive treatments, such as corticosteroid injections or surgical decompression, may be required for advanced or refractory cases .
In recent years, less invasive alternatives like perineural injection therapies have gained attention as promising options for carpal Tunnel Syndrome management . These therapies aim to reduce inflammation, relieve nerve compression, and promote tissue healing. The substances under investigation in this study include 5% dextrose, ozone, and glucocorticoids .
Dextrose acts as a neuroprotective and anti-inflammatory agent by modulating nociceptive pathways .It promotes tissue repair through proliferative and regenerative mechanisms, reducing local pain and inflammation. While hyperosmolar dextrose solutions may stabilize nerve function by deterring the release of pro-inflammatory cytokines, the effects of Dextrose 5% are primarily attributed to its role as an energy source for neuronal cells and its involvement in metabolic processes associated with neural repair.
Ozone, when used in medical-grade concentrations, exhibits potent anti-inflammatory and antioxidative effects. It neutralizes reactive oxygen species, reduces oxidative stress, and improves local oxygenation. These effects can enhance nerve function and reduce ischemia within the carpal tunnel .
Glucocorticoids, such as dexamethasone, exert their effects by suppressing local inflammatory responses. They inhibit the release of pro-inflammatory mediators, such as prostaglandins and cytokines, providing rapid symptom relief. However, their short-term efficacy and potential for symptom recurrence necessitate careful evaluation.
Despite the availability of these treatments, there is a lack of robust comparative studies to determine their relative efficacy and outcomes. This research aims to fill this gap by comparing the effectiveness of perineural injections with 5% dextrose, local ozone, and glucocorticoids in the management of Carpal Tunnel Syndrome.
Primary outcomes
• Evaluation of electrodiagnostic parameters (median nerve distal motor latency and sensory conduction velocity) at 3 months.
Secondary outcomes
- Evaluation of analgesic efficacy of Dextrose 5%, Ozone and Glucocorticoid local injection in carpal tunnel syndrome via assessment of Visual Analog Scale pain scores after injection by 1 and 3 months.
- Evaluation of Analgesic drugs requirement.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tasnim Ayad, Resident
- Phone Number: +20 10 12537424
- Email: tasnimayad15@gmail.com
Study Contact Backup
- Name: Tasnim Ayad, Resident
Study Locations
-
-
-
Tanta, Egypt
- Tanta University
-
Contact:
- Tasnim Ayad, Resident
- Phone Number: +20 10 12537424
- Email: tasnimayad15@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18-65 years with a clinical diagnosis of mild to moderate Carpal Tunnel Syndrome .
- Clinical diagnosis of mild to moderate Carpal Tunnel Syndrome , as classified by Bland neurophysiological classification scale: Mild Carpal Tunnel Syndrome : Slow Distal Sensory Latency(≥3.6 ms), Normal Distal Motor Latency(< 4.5 ms)
- Moderate Carpal Tunnel Syndrome : Slow Distal Sensory Latency (≥ 3.6 ms), Slow Distal Motor Latency (4.5 - 6.4 ms)
- Failure to respond to conservative treatments (e.g., splinting, activity modification, or oral medications) for at least 6 weeks.
Exclusion Criteria:
- Patient refusal.
- Severe Carpal Tunnel Syndrome requiring surgical intervention, as defined by the Bland neurophysiological classification scale: Severe Carpal Tunnel Syndrome: Absent Distal Sensory Latency and Slow Distal Motor Latency (4.5 - 6.4 ms)
- Previous corticosteroid injection for Carpal Tunnel Syndrome within the last 6 months.
- History of wrist trauma, surgery or anatomical abnormalities.
- Systemic conditions such as diabetes mellitus, thyroid dysfunction or rheumatoid arthritis.
- Pregnancy or lactation.
- Contraindications to any of the study interventions (e.g., allergy to glucocorticoids or ozone).
- Infection at wrist.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Perineural injection with 5% dextrose
|
Group 1: Perineural injection with 5% dextrose (D5W).
|
|
Experimental: Group 2
Local ozone injection
|
Group 2: Local ozone injection
|
|
Experimental: Group 3
Local glucocorticoid injection
|
Group 3: Local glucocorticoid injection (dexamethasone).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
median nerve distal motor latency
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluation of analgesic efficacy via assessment of Visual Analog Scale
Time Frame: At 1 and 3 months.
|
At 1 and 3 months.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Median Neuropathy
- Mononeuropathies
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Carpal Tunnel Syndrome
- Carbohydrates
- Polycyclic Compounds
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Pregnadienetriols
- Sugars
- Hexoses
- Monosaccharides
- Dexamethasone
- Glucose
Other Study ID Numbers
- 36264MS877/3/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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