Efficacy of Ozone Therapy and Splint in Carpal Tunnel Syndrome

NCT06649461 | Enrolling By Invitation

• 1 other identifier: 2024/10.6
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

splint; ozone therapy; rehabilitation

Outcome Measures

Primary Outcomes (3)

• Boston Carpal Tunnel Syndrome Questionnaire

  As the score obtained from the survey increases, the improvement increases.

  10 minutes

• visual analog scale

  As the score approaches 10, the intensity of pain felt increases.

  1 minute

• electromyography (EMG)

  In 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.

  10 minutes

Study Arms (2)

ozone injections

EXPERIMENTAL

Procedure: ozone injections; Other: Splint

splint

ACTIVE COMPARATOR

Other: Splint

Interventions

ozone injections PROCEDURE

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).

ozone injections

Splint OTHER

hand splint for night

ozone injections; splint

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Splints

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 18, 2024
• Study Start: October 15, 2024
• Primary Completion: October 29, 2024
• Study Completion: November 5, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)