Peripheral NeuropathyNCT05500079
Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome
A study testing Wrist splint and Pulsed radiofrequency current in people with Peripheral Neuropathy and Chronic Pain, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of transcutaneous pulsed radiofrequency current in the treatment of carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Neuropathy, Chronic Pain
- What is being tested?
- Wrist splint and Pulsed radiofrequency current
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Carpal tunnel syndrome detected by electroneuromyography
- Positive Tinel sign
Who cannot join
- Thenar muscle atrophy
- Weakness in the abductor pollicis brevis muscle
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Ankara, Dişkapi
About this study
Official title: Efficacy of Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome
The aim of this study is to examine the effect of transcutaneous pulsed radiofrequency current in the treatment of carpal tunnel syndrome.
Read the 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.
- Conditions
- Peripheral Neuropathy, Chronic Pain
- Being tested
- Wrist splint, Pulsed radiofrequency current
- Keywords
- carpal tunnel syndrome, pulsed radiofrequency treatment, transcutaneous pulsed radiofrequency
- Medical subject headings
- Peripheral Nervous System Diseases, Chronic Pain, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist splintDevice
A wrist splint is a It stabilizes your wrist. Wearing a wrist splint minimizes pressure on the median nerve.
Pulsed radiofrequency currentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Wrist splint group | Active comparator | The group to be treated with a wrist splint Receives: Device: Wrist splint |
| Transcutaneous pulsed RF group | Active comparator | The group to be treated with transcutaneous pulsed RF Receives: Other: Pulsed radiofrequency current |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Before treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Aug 2021
- Primary completion30 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- mehlika panpallı ateş, Study chair, Diskapi TRHömer taylan akkaya, Study director, Diskapi TRHHüseyin Alp Alptekin, Study chair, Diskapi TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500079
- Sponsor's protocol ID
- Carpal Tunnel Syndrome
- Status last verified
- May 2023
- First submitted
- 11 Aug 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05500079
- Acronym / sponsor ID
- Carpal Tunnel Syndrome
- Conditions
- Peripheral Neuropathy, Chronic Pain
- Keywords
- carpal tunnel syndrome, pulsed radiofrequency treatment, transcutaneous pulsed radiofrequency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wrist splint group | Active comparator | Device: Wrist splintThe group to be treated with a wrist splint |
| Transcutaneous pulsed RF group | Active comparator | Other: Pulsed radiofrequency currentThe group to be treated with transcutaneous pulsed RF |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Carpal tunnel syndrome detected by electroneuromyography
- Positive Tinel sign
Key exclusion criteria (2 listed)
- Thenar muscle atrophy
- Weakness in the abductor pollicis brevis muscle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist splintA wrist splint is a It stabilizes your wrist. Wearing a wrist splint minimizes pressure on the median nerve. | Device | Wrist splint group |
| Pulsed radiofrequency currentPulsed rf current is delivered to the median nerve trace via transcutaneous pads. Pain expression is suppressed in the dorsal horn of the spinal cord. | Other | Transcutaneous pulsed RF group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mehlika panpallı ateş study chair
Diskapi TRH
ömer taylan akkaya study director
Diskapi TRH
Hüseyin Alp Alptekin study chair
Diskapi TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist splint and Pulsed radiofrequency current in people with Peripheral Neuropathy and Chronic Pain, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 2 and 4 (time frame: Baseline, Week 2 and 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.