## Protocol Section
### Identification Module
**NCT ID:** NCT05500079

**Brief Title:** Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome

**Official Title:** Efficacy of Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome

#### Organization Study ID Info
**ID:** Carpal Tunnel Syndrome
#### Organization
**Class:** OTHER
**Full Name:** Diskapi Teaching and Research Hospital
### Status Module
#### Completion Date
**Date:** 2023-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-15

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-05-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-08-01

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2022-08-12
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-11
**Study First Submit QC Date:** 2022-08-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Diskapi Teaching and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Diskapi Teaching and Research Hospital

**Investigator Full Name:** Damla Yürük

**Investigator Title:** Director, medical doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Peripheral Neuropathy

- Chronic Pain

**Keywords:**

- carpal tunnel syndrome

- pulsed radiofrequency treatment

- transcutaneous pulsed radiofrequency

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The group to be treated with a wrist splint

**Intervention Names:**

- Device: Wrist splint

**Label:** Wrist splint group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** The group to be treated with transcutaneous pulsed RF

**Intervention Names:**

- Other: Pulsed radiofrequency current

**Label:** Transcutaneous pulsed RF group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Wrist splint group

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

**Name:** Wrist splint

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Transcutaneous pulsed RF group

**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.

**Name:** Pulsed radiofrequency current

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**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.

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

**Time Frame:** Baseline, Week 2 and 4

**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

**Measure:** Boston Carpal Tunnel Syndrome Questionnaire before treatment

**Time Frame:** Before treatment

### Eligibility Module

**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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

**Facility:** Diskapi Yildirim Beyazıt Teaching and Research Hospital

**State:** Dişkapi

#### Overall Officials

**Official 1:**

**Affiliation:** Diskapi TRH

**Name:** mehlika panpallı ateş

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Diskapi TRH

**Name:** ömer taylan akkaya

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** Diskapi TRH

**Name:** Hüseyin Alp Alptekin

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000020423

- Term: Median Neuropathy

- ID: D000020422

- Term: Mononeuropathies

- ID: D000009408

- Term: Nerve Compression Syndromes

- ID: D000012090

- Term: Cumulative Trauma Disorders

- ID: D000013180

- Term: Sprains and Strains

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M29442

- Name: Chronic Pain

- Relevance: HIGH

- As Found: Chronic Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: HIGH

- As Found: Peripheral Neuropathy

- ID: M5603

- Name: Carpal Tunnel Syndrome

- Relevance: HIGH

- As Found: Carpal Tunnel Syndrome

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22219

- Name: Median Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: M22218

- Name: Mononeuropathies

- Relevance: LOW

- As Found: Unknown

- ID: M12352

- Name: Nerve Compression Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M5853

- Name: Charcot-Marie-Tooth Disease

- Relevance: LOW

- As Found: Unknown

- ID: M18092

- Name: Hereditary Sensory and Motor Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M14930

- Name: Cumulative Trauma Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M15974

- Name: Sprains and Strains

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T1081

- Name: Charcot-Marie-Tooth Disease

- Relevance: LOW

- As Found: Unknown

- ID: T2761

- Name: Hereditary Motor and Sensory Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: T2766

- Name: Hereditary Neuropathy With Liability to Pressure Palsies

- Relevance: LOW

- As Found: Unknown

- ID: T5067

- Name: Roussy Levy Syndrome

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000002349

- Term: Carpal Tunnel Syndrome

- ID: D000059350

- Term: Chronic Pain

### Misc Info Module

- Version Holder: 2024-05-24
