The Effect of ESWT in Carpal Tunnel Syndrome

NCT04896398 | Completed DMC

• 1 other identifier: 2021-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

50 patients who meet the inclusion criteria will be included in this prospective, randomized and controlled study. Demographic information of the patients will be taken and recorded. After the patients are numbered according to the order of application, they will be divided into 2 groups as study and control groups according to randomization with the computer program. A total of 5 sessions of ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the study group (1st group) for 2 weeks. Patients will be taught median nerve and tendon shifting exercises and will be asked to do it regularly. Patients in the control group (Group 2) will be asked to perform median nerve and tendon shifting exercises only for the wrist. Patients will be evaluated before treatment, at 4 and 12 weeks after treatment. In the evaluation, Boston Carpal Tunnel Inquiry Form, pain severity assessment with VAS (visual analog scale), neuropathic pain intensity with LANSS scale and median nerve conduction velocity with EMG will be evaluated.

Conditions

Carpal Tunnel Syndrome

Keywords

ESWT

Outcome Measures

Primary Outcomes (1)

• Boston carpal tunnel questionnaire

  The functional levels of the patients will be evaluated with the Boston carpal tunnel questionnaire.

  3 months

Secondary Outcomes (2)

• Visual Analog Scale

  3 months

• Median nerve conduction study

  3 months

Study Arms (2)

ESWT Group

EXPERIMENTAL

A total of 5 sessions of ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the patients in this group for 2 weeks. Median nerve and tendon shifting exercises will be taught to the patients and they will be asked to do it regularly.

Device: ESWT

Control Group

NO INTERVENTION

Patients in the control group will be asked to do median nerve and tendon shifting exercises only for the wrist.

Interventions

ESWT DEVICE

In the study group, a total of 5 sessions of focused ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the affected wrist within 2 weeks.

ESWT Group

Eligibility Criteria

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

You may qualify if:

• Patients with a diagnosis of mild to moderate CTS in the nerve conduction study within the last 1 month,
• Positive Phalen and Tinnel tests in clinical examination
• Who agreed to participate in the study

You may not qualify if:

• Patients with cervical radiculopathy,
• Pregnant women,
• Rheumatoid arthritis,
• Thenar atrophy,
• Steroid injection or surgical procedure in the wrist in the last 3 months.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Ahmet Kıvanç Menekşeoğlu

Istanbul, 34015, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

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

Study Officials

• Ahmet K Menekşeoğlu

  Kanuni Sultan Süleyman Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The evaluation of the patients will be made by an evaluator who has no knowledge of group distribution.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: After the patients are numbered according to the order of application, they will be divided into 2 groups as study and control groups according to randomization made with the computer program (block randomization). A total of 5 sessions of ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the study group (1st group) for 2 weeks. Median nerve and tendon shifting exercises will be taught to the patients and they will be asked to do it regularly. Patients in the control group (Group 2) will be asked to perform median nerve and tendon shifting exercises only for the wrist. Patients will be evaluated before treatment and at 4 and 12 weeks after treatment.

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 21, 2021
• Study Start: June 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)