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Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05500079
Recruitment Status : Active, not recruiting
First Posted : August 12, 2022
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
Damla Yürük, Diskapi Teaching and Research Hospital

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

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Chronic Pain Device: Wrist splint Other: Pulsed radiofrequency current Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : June 1, 2023


Arm Intervention/treatment
Active Comparator: Wrist splint group
The group to be treated with a wrist splint
Device: Wrist splint
A wrist splint is a It stabilizes your wrist. Wearing a wrist splint minimizes pressure on the median nerve.

Active Comparator: Transcutaneous pulsed RF group
The group to be treated with transcutaneous pulsed RF
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.




Primary Outcome Measures :
  1. 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.

  2. 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




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Carpal tunnel syndrome detected by electroneuromyography
  • Positive Tinel sign

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05500079


Locations
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Turkey
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Ankara, Dişkapi, Turkey
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
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Study Chair: mehlika panpallı ateş Diskapi TRH
Study Director: ömer taylan akkaya Diskapi TRH
Study Chair: Hüseyin Alp Alptekin Diskapi TRH
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Responsible Party: Damla Yürük, Director, medical doctor, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT05500079    
Other Study ID Numbers: Carpal Tunnel Syndrome
First Posted: August 12, 2022    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Damla Yürük, Diskapi Teaching and Research Hospital:
carpal tunnel syndrome
pulsed radiofrequency treatment
transcutaneous pulsed radiofrequency
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Carpal Tunnel Syndrome
Chronic Pain
Pain
Neurologic Manifestations
Neuromuscular Diseases
Nervous System Diseases
Median Neuropathy
Mononeuropathies
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries