Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perineural injection with 5% dextrose (D5W)., Local ozone injection, Local glucocorticoid injection (dexamethasone)..
- Who it may be relevant to
- Registry conditions: Carpal Tunnel Syndrome (CTS), Glucocorticoid, Pain, Dextrose. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparative Study Between Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome
Overview
This study aims to compare the efficacy and outcomes of perineural injection with 5% dextrose, local ozone and glucocorticoid injection in the management of carpal tunnel syndrome.
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.
Interventions
- Drug Perineural injection with 5% dextrose (D5W).
Group 1: Perineural injection with 5% dextrose (D5W). - Drug Local ozone injection
Group 2: Local ozone injection - Drug Local glucocorticoid injection (dexamethasone).
Group 3: Local glucocorticoid injection (dexamethasone).
Primary outcome measures
- median nerve distal motor latency [Time frame: 3 months]
Secondary outcome measures (1)
- Evaluation of analgesic efficacy via assessment of Visual Analog Scale [Time frame: At 1 and 3 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07498998 · 36264MS877/3/25