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NCT06415331 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06415331
Other study ID # RSSA-00124
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2023
Est. completion date September 16, 2023

Study information
Verified date May 2024
Source Dr. Syaiful Anwar Hospital, Malang
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date September 16, 2023
Est. primary completion date July 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Pulsed radiofrequency
Individualized dose of pulsed radiofrequency is given for 6 minutes.
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

Locations
Country Name City State
Indonesia Dr. Saiful Anwar Hospital Malang East Java

Sponsors (1)
Lead Sponsor Collaborator
Dr. Syaiful Anwar Hospital, Malang

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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