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Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome

Primary Purpose

Peripheral Neuropathy, Chronic Pain

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Wrist splint
Pulsed radiofrequency current
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring carpal tunnel syndrome, pulsed radiofrequency treatment, transcutaneous pulsed radiofrequency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Carpal tunnel syndrome detected by electroneuromyography
  • Positive Tinel sign

Exclusion Criteria:

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

Sites / Locations

  • Diskapi Yildirim Beyazıt Teaching and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Wrist splint group

Transcutaneous pulsed RF group

Arm Description

The group to be treated with a wrist splint

The group to be treated with transcutaneous pulsed RF

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 11, 2022
Last Updated
May 15, 2023
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05500079
Brief Title
Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome
Official Title
Efficacy of Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Chronic Pain
Keywords
carpal tunnel syndrome, pulsed radiofrequency treatment, transcutaneous pulsed radiofrequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wrist splint group
Arm Type
Active Comparator
Arm Description
The group to be treated with a wrist splint
Arm Title
Transcutaneous pulsed RF group
Arm Type
Active Comparator
Arm Description
The group to be treated with transcutaneous pulsed RF
Intervention Type
Device
Intervention Name(s)
Wrist splint
Intervention Description
A wrist splint is a It stabilizes your wrist. Wearing a wrist splint minimizes pressure on the median nerve.
Intervention Type
Other
Intervention Name(s)
Pulsed radiofrequency current
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 2 and 4
Description
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.
Time Frame
Baseline, Week 2 and 4
Title
Boston Carpal Tunnel Syndrome Questionnaire before treatment
Description
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
Time Frame
Before treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Carpal tunnel syndrome detected by electroneuromyography Positive Tinel sign Exclusion Criteria: Thenar muscle atrophy Weakness in the abductor pollicis brevis muscle
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mehlika panpallı ateş
Organizational Affiliation
Diskapi TRH
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ömer taylan akkaya
Organizational Affiliation
Diskapi TRH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hüseyin Alp Alptekin
Organizational Affiliation
Diskapi TRH
Official's Role
Study Chair
Facility Information:
Facility Name
Diskapi Yildirim Beyazıt Teaching and Research Hospital
City
Ankara
State/Province
Dişkapi
Country
Turkey

12. IPD Sharing Statement

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Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome

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