Ozone Therapy in Patients With Carpal Tunnel Syndrome

NCT06469931 | Recruiting

• 1 other identifier: 2024/06-40
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

ESWT (Extracorporeal Shock Wave Therapy), which has been used in the treatment of musculoskeletal diseases in recent years, has come to the agenda as a new treatment method in Carpal Tunnel Syndrome. Although the effectiveness of ESWT, splinting and exercise applications in CTS patients is known in the literature, studies on the effectiveness of ozone therapy are limited. The aim of this study was to compare the efficacy of ozone therapy and ESWT applied in addition to splinting and exercise applications in patients diagnosed with CTS. The study will consist of 2 groups. In addition to exercise and splinting, 3 sessions of ozone therapy will be applied once a week to study group.Patients in the control group will receive ESWT once a week for 3 consecutive weeks in addition to exercise and splinting.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; ESWT; Ozone therapy

Outcome Measures

Primary Outcomes (1)

• Median nerve cross-sectional area

  Patients will be positioned seated facing the assessor, with the volar aspect of the wrist facing the air and at rest on a pillow. In the proximal carpal tunnel (at the level of the pisiform bone), the median nerve hyperechoic inner border line will be continuously traced and the transverse section surface area will be measured.

  2 minutes

Secondary Outcomes (1)

• Pain assesment

  1 minute

Other Outcomes (1)

• Hand grip strength assessment

  5 minutes

Study Arms (2)

Ozone therapy group

EXPERIMENTAL

In addition to range of motion exercises for wrist and hand and splinting, 3 sessions of ozone therapy will be applied once a week.

Other: range of motion exercises; Other: ozone therapy

Extracorporeal shock wave therapy group

EXPERIMENTAL

Patients in this group will receive ESWT once a week for 3 consecutive weeks in addition to range of motion exercisess for wrist and hand and splinting.

Other: range of motion exercises; Device: Extracorporeal shock wave therapy

Interventions

range of motion exercises OTHER

In addition to range of motion exercises for wrist and hand and splinting, 3 sessions of ozone therapy will be applied once a week.

Extracorporeal shock wave therapy group; Ozone therapy group

Extracorporeal shock wave therapy DEVICE

Patients in this group will receive ESWT once a week for 3 consecutive weeks in addition to range of motion exercises for wrist and hand and splinting.

Extracorporeal shock wave therapy group

ozone therapy OTHER

ozone therapy

Ozone therapy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18-65 who have been complaining for at least 3 months
• Diagnosed with mild or moderate Carpal Tunnel Syndrome

You may not qualify if:

• Cervical disc herniation or radiculopathy,
• Brachial plexus lesion
• Previous hand or neck surgery
• Pregnancy,
• History of fracture at the wrist level
• Inflammatory rheumatic disease

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Songul Baglan Yentur

Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Range of Motion, Articular; Extracorporeal Shockwave Therapy

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)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physiotherapy and Rehabilitation Department

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 24, 2024
• Study Start: June 20, 2024
• Primary Completion: August 20, 2024
• Study Completion: September 20, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)