## Protocol Section
### Identification Module
**NCT ID:** NCT06415331

**Brief Title:** Effectiveness of Conventional Therapy Plus Pulsed-Radiofrequency for Herniated Nucleus Pulposus

**Official Title:** Comparison of The Effectiveness Between Conventional Therapy and Conventional Therapy Plus Pulsed-Radiofrequency in Herniated Nucleus Pulposus Patients at Dr. Saiful Anwar Hospital, Malang

#### Organization Study ID Info
**ID:** RSSA-00124
#### Organization
**Class:** OTHER
**Full Name:** Dr. Syaiful Anwar Hospital, Malang
### Status Module
#### Completion Date
**Date:** 2023-09-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-07-14

**Type:** ACTUAL

#### Start Date
**Date:** 2023-02-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Dr. Syaiful Anwar Hospital, Malang

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The purpose of this research was to study whether the additional application of a certain medical intervention making use of radiofrequencies (pulsed-radiofrequency) would reduce pain in patients with herniated disk.

**Detailed Description:** Pain is an uncomfortable sensory and emotional experience that can affect quality of life. Low back pain (LBP) is one of the most common causes of pain, with herniated nucleus pulposus (HNP) being a common etiology. Pulsed radiofrequency (PRF) is a relatively novel technique that has shown promising results in many applications, including spinal pain conditions.

This quasi-experimental study aimed to compare pain levels between patients who underwent conventional therapy (CT) alone and CT plus PRF as management in patients with HNP. Pain severity was measured in the numeric rating scale before and 1 month after treatment.

### Conditions Module

**Conditions:**

- Herniated Nucleus Pulposus

- Pain

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects in this arm received interventions which were conventional, including opioid and non-opioid analgesics, adjuvant analgesics, muscle relaxants, and physiotherapy.

**Intervention Names:**

- Other: Conventional therapy

**Label:** Conventional therapy

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Subjects in this arm received pulsed radiofrequency in addition to the same conventional therapy as the other arm.

**Intervention Names:**

- Procedure: Pulsed radiofrequency

- Other: Conventional therapy

**Label:** Conventional therapy + pulsed radiofrequency

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Conventional therapy + pulsed radiofrequency

**Description:** Individualized dose of pulsed radiofrequency is given for 6 minutes.

**Name:** Pulsed radiofrequency

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Conventional therapy

- Conventional therapy + pulsed radiofrequency

**Description:** Conventional therapy for HNP consisting of:

* Acetaminophen
* NSAID: Etoricoxib, celecoxib, meloxicam, diclofenac, ibuprofen
* Muscle relaxant: eperisone, diazepam
* Opioid: codein, tramadol
* Adjuvant analgesics: Amitriptyline, pregabalin, gabapentin
* Physiotherapy: Short wave diathermy, ultrasound diathermy, transcutaneous electrical nerve stimulation, and exercise

**Name:** Conventional therapy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Pain severity measured with the numeric rating scale (NRS). The numeric rating scale measures pain on a scale of 0-10 with 0 representing "no pain" and 10 representing "the worst pain possible".

**Measure:** Pain severity

**Time Frame:** 1 month after treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Having an established diagnosis of HNP
* Complaint present for at least the pas 3 months
* Experiencing pain intensity of 4 or greater on the numeric rating scale
* Capable of giving informed consent

Exclusion Criteria:

* Pregnant patients
* Presence of infection at the site of pulsed radiofrequency
* HNP with red flags.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Malang

**Country:** Indonesia

**Facility:** Dr. Saiful Anwar Hospital

**State:** East Java

**Zip:** 65112

#### Overall Officials

**Official 1:**

**Affiliation:** Faculty of Medicine, Universitas Brawijaya, Malang, Indonesia

**Name:** Hana H Fachir, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: Antipy

- Name: Antipyretics

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: AntiConv

- Name: Anticonvulsants

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: MuRelCen

- Name: Muscle Relaxants, Central

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: AnTuAg

- Name: Antitussive Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: VaDiAg

- Name: Vasodilator Agents

### Intervention Browse Module - Browse Leaves

- ID: M2340

- Name: Acetaminophen

- Relevance: LOW

- As Found: Unknown

- ID: M10102

- Name: Ibuprofen

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M476

- Name: Pregabalin

- Relevance: LOW

- As Found: Unknown

- ID: M3977

- Name: Amitriptyline

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M1869

- Name: Etoricoxib

- Relevance: LOW

- As Found: Unknown

- ID: M16901

- Name: Tramadol

- Relevance: LOW

- As Found: Unknown

- ID: M7197

- Name: Diclofenac

- Relevance: LOW

- As Found: Unknown

- ID: M277

- Name: Celecoxib

- Relevance: LOW

- As Found: Unknown

- ID: M1694

- Name: Gabapentin

- Relevance: LOW

- As Found: Unknown

- ID: M1713

- Name: Meloxicam

- Relevance: LOW

- As Found: Unknown

- ID: M7167

- Name: Diazepam

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M6290

- Name: Codeine

- Relevance: LOW

- As Found: Unknown

- ID: M208150

- Name: Eperisone

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
