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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Herniated Nucleus Pulposus
• Intervention / Treatment: Other: Conventional therapy; Procedure: Pulsed radiofrequency

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • East Java
    • Malang, East Java, Indonesia, 65112
      • Dr. Saiful Anwar Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional therapy; Subjects in this arm received interventions which were conventional, including opioid and non-opioid analgesics, adjuvant analgesics, muscle relaxants, and physiotherapy.	Other: 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
Experimental: Conventional therapy + pulsed radiofrequency; Subjects in this arm received pulsed radiofrequency in addition to the same conventional therapy as the other arm.	Other: 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; Procedure: Pulsed radiofrequency; Individualized dose of pulsed radiofrequency is given for 6 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain severity	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".	1 month after treatment

Collaborators and Investigators

• Sponsor: Dr. Syaiful Anwar Hospital, Malang
• Investigators: Principal Investigator: Hana H Fachir, M.D., Faculty of Medicine, Universitas Brawijaya, Malang, Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): September 16, 2023

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RSSA-00124

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No