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Efficacy of Ozone Therapy and Splint in Carpal Tunnel Syndrome

Splint with Ozone Injection for Mild and Moderate Carpal Tunnel: an Electrodiagnostic Study

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06649461
Enrollment
34
Registered
2024-10-18
Start date
2024-10-15
Completion date
2024-11-05
Last updated
2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

splint, ozone therapy, rehabilitation

Brief summary

This study will investigate the effectiveness of repeated ozone therapy combined with splint therapy for carpal tunnel syndrome (CTS).CTS patients will be split into two groups: ozone plus splint and splint only. Both groups will use wrist splints for 3 weeks, with the ozone+splint group receiving weekly ozone injections for three weeks.

Interventions

PROCEDUREozone injections

Ozone injections (5 mL/10 μg/dL) were administered under aseptic conditions, with the wrist fixed in dorsiflexion, and with the insulin injector, a 23-gauge needle was inserted between the palmaris longus and flexor carpi radialis muscles at a 45-degree angle from the palmar distal line (Salutem/19147884379).

OTHERSplint

hand splint for night

Sponsors

Selcuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* being 18-65 years, with mil-modarete CTS, symptoms continued for at least 3 months

Exclusion criteria

* hand edema or prior injections, thenar atrophy, prior CTS surgery, severe EMG results, recent physical therapy, steroids, or platelet-rich plasma for CTS in the past year, and conditions causing secondary CTS (e.g., thyroid disorders, diabetes, pregnancy, rheumatoid arthritis, Dupuytren's contracture, inflammatory arthritis, connective tissue diseases). Also excluded: neck or arm pain conditions (e.g., cervical disc herniation, wrist fracture, proximal upper extremity entrapment neuropathy, polyneuropathy, peripheral nerve damage, fibromyalgia), history of G6PD deficiency, uncontrolled hyperthyroidism, thrombocytopenia, and contraindications to general ozone therapy (e.g., ACE inhibitors for severe cardiovascular instability).

Design outcomes

Primary

MeasureTime frameDescription
Boston Carpal Tunnel Syndrome Questionnaire10 minutesAs the score obtained from the survey increases, the improvement increases.
visual analog scale1 minuteAs the score approaches 10, the intensity of pain felt increases.
electromyography (EMG)10 minutesIn the electrophysiological examination, median sensory nerve conduction studies and median motor nerve conduction studies will be measured. Median motor nerve latency, median motor nerve conduction velocity, and compound muscle action potential amplitude will be measured and recorded.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026