Effectiveness of Conventional Therapy Plus Pulsed-Radiofrequency for Herniated Nucleus Pulposus

NCT ID: NCT06415331

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-02

Study Completion Date

2023-09-16

Brief Summary

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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

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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

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Herniated Nucleus Pulposus Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional therapy

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

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type OTHER

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

Conventional therapy + pulsed radiofrequency

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

Group Type EXPERIMENTAL

Pulsed radiofrequency

Intervention Type PROCEDURE

Individualized dose of pulsed radiofrequency is given for 6 minutes.

Conventional therapy

Intervention Type OTHER

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

Interventions

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Pulsed radiofrequency

Individualized dose of pulsed radiofrequency is given for 6 minutes.

Intervention Type PROCEDURE

Conventional therapy

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Syaiful Anwar Hospital, Malang

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hana H Fachir, M.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Universitas Brawijaya, Malang, Indonesia

Locations

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Dr. Saiful Anwar Hospital

Malang, East Java, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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RSSA-00124

Identifier Type: -

Identifier Source: org_study_id

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