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Clinical Trials/NCT05500079
NCT05500079Active, not recruitingNot Applicable

Efficacy of Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome

Diskapi Teaching and Research Hospital1 site in 1 country60 target enrollmentStarted: August 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
60
Locations
1
Primary Endpoint
Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 2 and 4

Study Overview

Brief Summary

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

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Carpal tunnel syndrome detected by electroneuromyography
  • •Positive Tinel sign

Exclusion Criteria

  • •Thenar muscle atrophy
  • •Weakness in the abductor pollicis brevis muscle

Arms & Interventions

Wrist splint group

Active Comparator

The group to be treated with a wrist splint

Intervention: Wrist splint (Device)

Transcutaneous pulsed RF group

Active Comparator

The group to be treated with transcutaneous pulsed RF

Intervention: Pulsed radiofrequency current (Other)

Outcomes

Primary Outcomes

Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 2 and 4

Time Frame: Baseline, 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.

Boston Carpal Tunnel Syndrome Questionnaire before treatment

Time Frame: 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. ıncluding Symptom Severity Scale is 11: no symptoms, 55: worst symptoms and Functional Disability Scale (FDS) no difficulties:8, worst difficulties: 40

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Damla Yürük

Director, medical doctor

Diskapi Teaching and Research Hospital

Study Sites (1)

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