Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome

Chronic Pain Clinical Trial

Official title:

Efficacy of Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05500079
• Other study ID #: Carpal Tunnel Syndrome
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2023
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to examine the effect of transcutaneous pulsed radiofrequency current in the treatment of carpal tunnel syndrome.

Description:

Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy. Wrist splint is the first-line treatment option for CTS. Pulsed radiofrequency therapy is used in the treatment of chronic pain.

60 carpal tunnel syndrome patients diagnosed with electroneuromyelography will be included in the study. 30 patients will wear wrist splints for 1 month. In the other 30 patients, pulsed radiofrequency current will be given through the wrist median nerve trace. RF current will be applied through transcutaneous pads. It will be applied once a week for a total of 2 sessions, 8 minutes each. Boston carpal tunnel syndrome questionnaire with visual analog scale (VAS) will be applied to all patients before and after the treatment at 1 week and 1 month.

Our aim is to compare the effectiveness of wrist splint and pulsed rf therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 1, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Carpal tunnel syndrome detected by electroneuromyography

• Positive Tinel sign

Exclusion Criteria:

• Thenar muscle atrophy

• Weakness in the abductor pollicis brevis muscle

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Chronic Pain
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Device:
• Wrist splint
A wrist splint is a It stabilizes your wrist. Wearing a wrist splint minimizes pressure on the median nerve.

Other:
• Pulsed radiofrequency current
Pulsed rf current is delivered to the median nerve trace via transcutaneous pads. Pain expression is suppressed in the dorsal horn of the spinal cord.

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Teaching and Research Hospital	Ankara	Diskapi

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 2 and 4	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "0=no pain" and "10=worst pain.	Baseline, Week 2 and 4
Primary	Boston Carpal Tunnel Syndrome Questionnaire before treatment	The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome.; including Symptom Severity Scale is 11: no symptoms, 55: worst symptoms and Functional Disability Scale (FDS) no difficulties:8, worst difficulties: 40	Before treatment