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Completed

NCT Number: NCT06415331

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

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.

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Key information

Conditions

Herniated Nucleus Pulposus Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Saiful Anwar Hospital

Malang, East Java, 65112, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pulsed radiofrequency

Procedure

Individualized dose of pulsed radiofrequency is given for 6 minutes.

Conventional Therapy

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

Primary outcomes

  1. Pain severity

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Dr. Syaiful Anwar Hospital, Malang

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 16, 2024
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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