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

NCT06415331 | Completed

• 1 other identifier: RSSA-00124
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Herniated Nucleus Pulposus; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conventional therapy

ACTIVE COMPARATOR

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 + pulsed radiofrequency

EXPERIMENTAL

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

Procedure: Pulsed radiofrequency; Other: Conventional therapy

Interventions

Pulsed radiofrequency PROCEDURE

Individualized dose of pulsed radiofrequency is given for 6 minutes.

Conventional therapy + pulsed radiofrequency

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

Conventional therapy; Conventional therapy + pulsed radiofrequency

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant patients
• Presence of infection at the site of pulsed radiofrequency
• HNP with red flags.

Sponsors & Collaborators

• Dr. Syaiful Anwar Hospital, Malang: lead

Study Sites (1)

Dr. Saiful Anwar Hospital

Malang, East Java, 65112, Indonesia

Location

MeSH Terms

Conditions

Pain

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Officials

• Hana H Fachir, M.D.

  Faculty of Medicine, Universitas Brawijaya, Malang, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: February 2, 2023
• Primary Completion: July 14, 2023
• Study Completion: September 16, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

ID (1)