Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome

NCT05500079 | Unknown

• 1 other identifier: Carpal Tunnel Syndrome
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Neuropathy; Chronic Pain

Keywords

carpal tunnel syndrome; pulsed radiofrequency treatment; transcutaneous pulsed radiofrequency

Outcome Measures

Primary Outcomes (2)

• 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

• 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

  Before treatment

Study Arms (2)

Wrist splint group

ACTIVE COMPARATOR

The group to be treated with a wrist splint

Device: Wrist splint

Transcutaneous pulsed RF group

ACTIVE COMPARATOR

The group to be treated with transcutaneous pulsed RF

Other: Pulsed radiofrequency current

Interventions

Wrist splint DEVICE

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

Wrist splint group

Pulsed radiofrequency current OTHER

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.

Transcutaneous pulsed RF 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:

• Carpal tunnel syndrome detected by electroneuromyography
• Positive Tinel sign

You may not qualify if:

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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Diskapi Yildirim Beyazıt Teaching and Research Hospital

Ankara, Dişkapi, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Chronic Pain; Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• mehlika panpallı ateş

  Diskapi TRH

  STUDY CHAIR

• ömer taylan akkaya

  Diskapi TRH

  STUDY DIRECTOR

• Hüseyin Alp Alptekin

  Diskapi TRH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, medical doctor

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 12, 2022
• Study Start: August 1, 2021
• Primary Completion: May 30, 2023
• Study Completion: June 1, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

TU (1)