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NCT Number: NCT07498998

Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perineural injection with 5% dextrose (D5W).

Drug

Group 1: Perineural injection with 5% dextrose (D5W).

Local ozone injection

Drug

Group 2: Local ozone injection

Local glucocorticoid injection (dexamethasone).

Drug

Group 3: Local glucocorticoid injection (dexamethasone).

Primary outcomes

  1. median nerve distal motor latency

    Time frame: 3 months

Secondary outcomes

  1. Evaluation of analgesic efficacy via assessment of Visual Analog Scale

    Time frame: At 1 and 3 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Tasnim Ayad, Resident

CONTACT

[email protected]

+20 10 12537424

Tasnim Ayad, Resident

CONTACT

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

A Comparative Study Between Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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