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

Not Applicable

Completed

• Conditions: Pain; Herniated Nucleus Pulposus
• Interventions: Other: Conventional therapy; Procedure: Pulsed radiofrequency

• Registration Number: NCT06415331
• Lead Sponsor: Dr. Syaiful Anwar Hospital, Malang

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.

Study Timeline

• Study Start: 2023-02-02
• Primary Completion: 2023-07-14
• Study Completion: 2023-09-16
• Status Verified: 2024-05
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional therapy	Conventional therapy	Subjects in this arm received interventions which were conventional, including opioid and non-opioid analgesics, adjuvant analgesics, muscle relaxants, and physiotherapy.
Conventional therapy + pulsed radiofrequency	Conventional therapy	Subjects in this arm received pulsed radiofrequency in addition to the same conventional therapy as the other arm.
Conventional therapy + pulsed radiofrequency	Pulsed radiofrequency	Subjects in this arm received pulsed radiofrequency in addition to the same conventional therapy as the other arm.

Primary Outcome Measures

Name	Time	Method
Pain severity	1 month after treatment	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".

Trial Locations

Locations (1)

Dr. Saiful Anwar Hospital; 🇮🇩 Malang, East Java, Indonesia