The Effect of Radiofrequency of 448 kHz on Pain and Function

January 11, 2023 updated by: Ivan Jurak, University of Applied Health Sciences

The Effect of Capacitive and Resistive Monopolar Radiofrequency of 448 kHz on Pain and Function in People Diagnosed With Lumbar Pain Syndrome

The goal of this trial is to compare the effects 448kHz capacitive resistive monopolar radiofrequency (CRM) with Proprioceptive Neuromuscular Facilitation (PNF) versus only PNF in chronic low back pain patients.

The main questions it aims to answer are:

  1. Is there any difference in interventions on reduction of pain.
  2. Is there any difference in interventions on reduction of disability.

Participants will in the experimental group will be treated with a combination of:

  1. 448kHz capacitive resistive monopolar radiofrequency and,
  2. PNF intervention

Participants will in the control group will be treated only using

1. PNF intervention (identical to experimental group)

Researchers will compare experimental and control group to see if there are differences in reduction of pain and disability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • Varaždinska
      • Varaždin, Varaždinska, Croatia, 42000
        • Polyclinic Cerebellum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • older than 18 years, chronic low back pain (CLBP)

Exclusion Criteria:

  • spinal fractures, radiculopathies, history of spinal surgery, spinal stenosis, history of thrombosis, pacemaker, pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group

Participants in the experimental group will be treated with a combination of 448kHz capacitive resistive monopolar radiofrequency and Proprioceptive neuromuscular facilitation (PNF) over the course of two weeks.

  1. 448 kHz radio frequency therapy will be carried for a duration of 15 min. Contact cream will be applied beforehand to increase the electrical conductivity in the treated area.
  2. After the radiofrequency therapy, participants will exercise for exactly 20 minutes using the PNF concept exercises to mobilize the pelvis and lumbar spine, primarily strengthening the muscles of the abdomen, back and hips.

Therapy will be administered for a total of 5 times in two weeks. Three times in week 1 and two times in week 2.
Device: 448kHz capacitive resistive monopolar radiofrequency
Capacitive resistive monopolar radiofrequency (CRM) treatment is a type of medical procedure that uses radiofrequency energy to heat the targeted tissue.
Other: Proprioceptive Neuromuscular Facilitation
Proprioceptive neuromuscular facilitation (PNF) is a type of physical therapy that uses techniques such as stretching and strengthening exercises to improve muscle function and movement patterns.
Other Names:
  • PNF
Active Comparator: Control group

Participants will exercise for exactly 20 minutes, over the course of two weeks, using the PNF concept exercises to mobilize the pelvis and lumbar spine, primarily strengthening the muscles of the abdomen, back and hips.

Therapy will be administered for a total of 5 times in two weeks. Three times in week 1 and two times in week 2.

This is identical intervention and the second intervention in the experimental group.
Other: Proprioceptive Neuromuscular Facilitation
Proprioceptive neuromuscular facilitation (PNF) is a type of physical therapy that uses techniques such as stretching and strengthening exercises to improve muscle function and movement patterns.
Other Names:
  • PNF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline: Pain - Visual Analogue Scale (VAS)
Time Frame: Change from baseline pain after two weeks (14 days).
Change from baseline pain, measured by 0-10 Visual Analogue Scale (VAS). VAS has a minimum score of 0 and a maximum score of 10. Higher score indicates a worse outcome (e.g., greater pain intensity).
Change from baseline pain after two weeks (14 days).
Change from baseline: Disability - ODI (Oswestry Low Back Pain Disability Questionnaire)
Time Frame: Change from baseline disability after two weeks (14 days).
Change from baseline disability, measured by Oswestry Low Back Pain Disability Questionnaire. ODI has a minimum score of 0% and maximum score of 100%. Higher score indicates a worse outcome (e.g., greater disability).
Change from baseline disability after two weeks (14 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline: Disability - Quebec Back Pain Disability Scale (QBPD)
Time Frame: Change from baseline disability after two weeks (14 days).
Change from baseline disability, measured by Quebec Back Pain Disability Scale. QBPD has a minimum score of 20 and maximum score of 100. Higher score indicates a worse outcome (e.g., greater disability).
Change from baseline disability after two weeks (14 days).
Change from baseline: Roland-Morris Disability Questionnaire (RMDQ)
Time Frame: Change from baseline disability after two weeks (14 days).
Change from baseline disability, measured by Roland-Morris Disability Questionnaire. RMDQ has a minimum score of 0 and maximum score of 24. Higher score indicates a worse outcome (e.g., greater pain-related disability).
Change from baseline disability after two weeks (14 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Applied Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

December 24, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 602-04/21-25/840

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymized IPD will be shared either as a supplement to manuscript or on adequate server for storing IPD data.

Data will always be available upon inquiry by email to lead investigators. All variables that were measured will be included in the dataset.

IPD Sharing Time Frame

When: Upon publication. How long: Indefinitely.

IPD Sharing Access Criteria

Available to all. No criteria for accessing the data.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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